Pick Topic
Review Topic
List Experts
Examine Expert
Save Expert
  Site Guide ··   
Psoriasis: HELP
Articles by Kenneth B. Gordon
Based on 67 articles published since 2008
||||

Between 2008 and 2019, K. B. Gordon wrote the following 67 articles about Psoriasis.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3
1 Guideline Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. 2019

Menter, Alan / Strober, Bruce E / Kaplan, Daniel H / Kivelevitch, Dario / Prater, Elizabeth Farley / Stoff, Benjamin / Armstrong, April W / Connor, Cody / Cordoro, Kelly M / Davis, Dawn M R / Elewski, Boni E / Gelfand, Joel M / Gordon, Kenneth B / Gottlieb, Alice B / Kavanaugh, Arthur / Kiselica, Matthew / Korman, Neil J / Kroshinsky, Daniela / Lebwohl, Mark / Leonardi, Craig L / Lichten, Jason / Lim, Henry W / Mehta, Nehal N / Paller, Amy S / Parra, Sylvia L / Pathy, Arun L / Rupani, Reena N / Siegel, Michael / Wong, Emily B / Wu, Jashin J / Hariharan, Vidhya / Elmets, Craig A. ·Baylor Scott and White, Dallas, Texas. · University of Connecticut, Farmington, Connecticut; Probity Medical Research, Waterloo, Ontario, Canada. · University of Pittsburgh, Pittsburgh, Pennsylvania. · University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma. · Emory University School of Medicine, Atlanta, Georgia. · University of Southern California, Los Angeles, San Francisco. · University of Alabama, Birmingham, Alabama. · University of California, San Francisco School of Medicine, Department of Dermatology, San Francisco, California. · Mayo Clinic, Rochester, Minnesota. · University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania. · Medical College of Wisconsin, Milwaukee, Wisconsin. · Department of Dermatology, Icahn School of Medicine at Mt. Sinai, New York. · University of California San Diego, San Diego, California. · National Psoriasis Foundation, Portland, Oregon. · University Hospitals Cleveland Medical Center, Cleveland, Ohio. · Massachusetts General Hospital, Boston, Massachusetts. · Central Dermatology, St. Louis, Missouri. · Department of Dermatology, Henry Ford Hospital, Detroit, Michigan. · National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland. · Northwestern University Feinberg School of Medicine, Chicago, Illinois. · Dermatology and Skin Surgery, Sumter, South Carolina. · Colorado Permanente Medical Group, Centennial, Colorado. · San Antonio Uniformed Services Health Education Consortium, Joint-Base San Antonio. · Dermatology Research and Education Foundation, Irvine, California. · American Academy of Dermatology, Rosemont, Illinois. Electronic address: vhariharan@aad.org. ·J Am Acad Dermatol · Pubmed #30772098.

ABSTRACT: Psoriasis is a chronic, inflammatory multisystem disease that affects up to 3.2% of the US population. This guideline addresses important clinical questions that arise in psoriasis management and care, providing recommendations based on the available evidence. The treatment of psoriasis with biologic agents will be reviewed, emphasizing treatment recommendations and the role of the dermatologist in monitoring and educating patients regarding benefits as well as associated risks.

2 Guideline Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with awareness and attention to comorbidities. 2019

Elmets, Craig A / Leonardi, Craig L / Davis, Dawn M R / Gelfand, Joel M / Lichten, Jason / Mehta, Nehal N / Armstrong, April W / Connor, Cody / Cordoro, Kelly M / Elewski, Boni E / Gordon, Kenneth B / Gottlieb, Alice B / Kaplan, Daniel H / Kavanaugh, Arthur / Kivelevitch, Dario / Kiselica, Matthew / Korman, Neil J / Kroshinsky, Daniela / Lebwohl, Mark / Lim, Henry W / Paller, Amy S / Parra, Sylvia L / Pathy, Arun L / Prater, Elizabeth Farley / Rupani, Reena / Siegel, Michael / Stoff, Benjamin / Strober, Bruce E / Wong, Emily B / Wu, Jashin J / Hariharan, Vidhya / Menter, Alan. ·University of Alabama, Birmingham, Alabama. · Central Dermatology, St. Louis, Missouri. · Mayo Clinic, Rochester, Minnesota. · University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania. · National Psoriasis Foundation, Portland, Oregon. · National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland. · University of Southern California, Los Angeles, California. · Department of Dermatology, University of California San Francisco School of MedicineSan Francisco, California. · Medical College of Wisconsin, Milwaukee, Wisconsin. · Department of Dermatology, Icahn School of Medicine at Mt. Sinai, New York, New York. · University of Pittsburgh, Pennsylvania. · University of California San Diego, San Diego, California. · Baylor Scott and White, Dallas, Texas. · University Hospitals Cleveland Medical Center, Cleveland, Ohio. · Massachusetts General Hospital, Boston, Massachusetts. · Department of Dermatology, Henry Ford Hospital, Detroit, Michigan. · Northwestern University Feinberg School of Medicine, Chicago, Illinois. · Dermatology and Skin Surgery, Sumter, South Carolina. · Colorado Permanente Medical Group, Centennial, Colorado. · University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma. · Icahn School of Medicine at Mount Sinai, New York, New York. · Emory University School of Medicine, Atlanta, Georgia. · University of Connecticut, Farmington, Connecticut; Probity Medical Research, Waterloo, Canada. · San Antonio Uniformed Services Health Education Consortium, Joint-Base San Antonio, Texas. · Dermatology Research and Education Foundation, Irvine, California. · American Academy of Dermatology, Rosemont, Illinois. Electronic address: vhariharan@aad.org. ·J Am Acad Dermatol · Pubmed #30772097.

ABSTRACT: Psoriasis is a chronic, inflammatory, multisystem disease that affects up to 3.2% of the US population. This guideline addresses important clinical questions that arise in psoriasis management and care, providing recommendations on the basis of available evidence.

3 Guideline Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. 2009

Menter, Alan / Korman, Neil J / Elmets, Craig A / Feldman, Steven R / Gelfand, Joel M / Gordon, Kenneth B / Gottlieb, Alice / Koo, John Y M / Lebwohl, Mark / Lim, Henry W / Van Voorhees, Abby S / Beutner, Karl R / Bhushan, Reva / Anonymous150622. ·Baylor University Medical Center, Dallas, Texas, USA. ·J Am Acad Dermatol · Pubmed #19217694.

ABSTRACT: Psoriasis is a common, chronic, inflammatory, multi-system disease with predominantly skin and joint manifestations affecting approximately 2% of the population. In this third of 6 sections of the guidelines of care for psoriasis, we discuss the use of topical medications for the treatment of psoriasis. The majority of patients with psoriasis have limited disease (<5% body surface area involvement) and can be treated with topical agents, which generally provide a high efficacy-to-safety ratio. Topical agents may also be used adjunctively for patients with more extensive psoriasis undergoing therapy with either ultraviolet light, systemic or biologic medications. However, the use of topical agents as monotherapy in the setting of extensive disease or in the setting of limited, but recalcitrant, disease is not routinely recommended. Treatment should be tailored to meet individual patients' needs. We will discuss the efficacy and safety of as well as offer recommendations for the use of topical corticosteroids, vitamin D analogues, tazarotene, tacrolimus, pimecrolimus, emollients, salicylic acid, anthralin, coal tar, as well as combination therapy.

4 Guideline Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. 2008

Gottlieb, Alice / Korman, Neil J / Gordon, Kenneth B / Feldman, Steven R / Lebwohl, Mark / Koo, John Y M / Van Voorhees, Abby S / Elmets, Craig A / Leonardi, Craig L / Beutner, Karl R / Bhushan, Reva / Menter, Alan. ·Department of Dermatology, Tufts-New England Medical Center, Tufts University School of Medicine, Boston, Massachusetts, USA. ·J Am Acad Dermatol · Pubmed #18423261.

ABSTRACT: Psoriasis is a common, chronic, inflammatory, multisystem disease with predominantly skin and joint manifestations affecting approximately 2% of the population. In this second of 5 sections of the guidelines of care for psoriasis, we give an overview of psoriatic arthritis including its cardinal clinical features, pathogenesis, prognosis, classification, assessment tools used to evaluate psoriatic arthritis, and the approach to treatment. Although patients with mild to moderate psoriatic arthritis may be treated with nonsteroidal anti-inflammatory drugs and/or intra-articular steroid injections, the use of disease-modifying antirheumatic drugs, particularly methotrexate, along with the biologic agents, are considered the standard of care in patients with more significant psoriatic arthritis. We will discuss the use of disease-modifying antirheumatic drugs and the biologic therapies in the treatment of patients with moderate to severe psoriatic arthritis.

5 Guideline Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. 2008

Menter, Alan / Gottlieb, Alice / Feldman, Steven R / Van Voorhees, Abby S / Leonardi, Craig L / Gordon, Kenneth B / Lebwohl, Mark / Koo, John Y M / Elmets, Craig A / Korman, Neil J / Beutner, Karl R / Bhushan, Reva. ·Baylor University Medical Center, Dallas, Texas, USA. ·J Am Acad Dermatol · Pubmed #18423260.

ABSTRACT: Psoriasis is a common, chronic, inflammatory, multisystem disease with predominantly skin and joint manifestations affecting approximately 2% of the population. In this first of 5 sections of the guidelines of care for psoriasis, we discuss the classification of psoriasis; associated comorbidities including autoimmune diseases, cardiovascular risk, psychiatric/psychologic issues, and cancer risk; along with assessment tools for skin disease and quality-of-life issues. Finally, we will discuss the safety and efficacy of the biologic treatments used to treat patients with psoriasis.

6 Guideline National Psoriasis Foundation clinical consensus on psoriasis comorbidities and recommendations for screening. 2008

Kimball, Alexa B / Gladman, Dafna / Gelfand, Joel M / Gordon, Kenneth / Horn, Elizabeth J / Korman, Neil J / Korver, Gretchen / Krueger, Gerald G / Strober, Bruce E / Lebwohl, Mark G / Anonymous5660593. ·Department of Dermatology, Harvard Medical School and Massachusetts General Hospital, Boston, Massachusetts 02114, USA. harvardskinstudies@partners.org ·J Am Acad Dermatol · Pubmed #18313171.

ABSTRACT: There have been several articles and reports in recent months about comorbidities and risks that affect psoriasis patients in addition to their underlying disease. This piece reviews the current literature and begins to address what should be done with this new information by updating the clinician about what health screening tests, preventative exams, and referrals should be considered in this population.

7 Editorial Systemics to topicals in psoriasis: the unfilled need. 2013

Lingam, P / Nwe, S / Gordon, K B. · ·Br J Dermatol · Pubmed #23834112.

ABSTRACT: -- No abstract --

8 Editorial Strategies for treatment with anti-tumor necrosis factor agents in psoriasis: maintaining efficacy and safety for the long haul. 2010

Gordon, Kenneth B / Gandhi, Mona. · ·Arch Dermatol · Pubmed #20157030.

ABSTRACT: -- No abstract --

9 Review Unmet needs in the treatment of psoriasis. 2014

Kragballe, Knud / van de Kerkhof, Peter C M / Gordon, Kenneth B. ·Dept of Dermatology, Århus University Hospital, Århus Sygehus, P.P. Ørums Gade 11, 8000 Århus, Denmark. · Dept of Dermatology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. · Dept of Dermatology, Northwestern University, Feinberg School of Medicine, Chicago, Illinois, USA. ·Eur J Dermatol · Pubmed #25115238.

ABSTRACT: Biologics have greatly improved the treatment of moderate-to-severe plaque psoriasis, as most patients are now able to achieve an initial improvement of 75% in the Psoriasis Area and Severity Index. However, only ∼20%-57% reach a 90% improvement in this measurement and responses may be lost over time. In addition, there are potential safety issues as TNF-inhibitor biologics have been associated with infections or non-melanoma skin malignancies. Here we review unmet needs with current therapies for psoriasis. We researched the medical literature to discuss new therapies in development and assess their potential to meet these needs. Several new classes of anti-psoriatic drugs are currently undergoing clinical development and potential improvements with these new therapies include attaining earlier and higher-level responses that are durable, more specific targeting of cytokines involved directly in psoriatic inflammation, and new therapies offering convenient administration. Additionally, based on results from clinical trials evaluating these new agents, it may be possible to find predictive markers that identify patients best treated with certain drug classes, those prone to lose treatment responses and patients who can discontinue treatment and remain in remission. It remains to be determined whether the promising results seen in early studies of therapies in development for psoriasis will translate into actual improvements over currently available treatment options.

10 Review Rationale and early clinical data on IL-17 blockade in psoriasis. 2013

Nwe, Steven M / Champlain, Amanda H / Gordon, Kenneth B. ·Department of Dermatology, Northwestern University, Feinberg School of Medicine, 676 N. St. Clair St., Suite 1600, Chicago, IL 60611, USA. ·Expert Rev Clin Immunol · Pubmed #23899238.

ABSTRACT: Psoriasis vulgaris is a chronic, immune-mediated, inflammatory disease that affects between 2 and 3% of the US population. Often severely physically and emotionally debilitating, psoriasis has driven investigators to strive to better characterize its complex immune pathogenesis. Some of the most promising and exciting advances have occurred in the last decade with recognition of the IL-23/Th17 pathway in disease initiation, progression and maintenance. Biologic therapies targeting various points in the pathway have met with success, prompting the study of the safety and efficacy of IL-17 blockade for moderate-to-severe plaque psoriasis. This article will review the rationale and early clinical data on IL-17 blockade in psoriasis.

11 Review Adalimumab: long-term safety in 23 458 patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and Crohn's disease. 2013

Burmester, Gerd R / Panaccione, Remo / Gordon, Kenneth B / McIlraith, Melissa J / Lacerda, Ana P M. ·Correspondence to Professor G R Burmester, Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Charitéplatz 1, 10117 Berlin, Germany. gerd.burmester@charite.de ·Ann Rheum Dis · Pubmed #22562972.

ABSTRACT: BACKGROUND: As long-term treatment with antitumour necrosis factor (TNF) drugs becomes accepted practice, the risk assessment requires an understanding of anti-TNF long-term safety. Registry safety data in rheumatoid arthritis (RA) are available, but these patients may not be monitored as closely as patients in a clinical trial. Cross-indication safety reviews of available anti-TNF agents are limited. OBJECTIVE: To analyse the long-term safety of adalimumab treatment. METHODS: This analysis included 23 458 patients exposed to adalimumab in 71 global clinical trials in RA, juvenile idiopathic arthritis, ankylosing spondylitis (AS), psoriatic arthritis, psoriasis (Ps) and Crohn's disease (CD). Events per 100 patient-years were calculated using events reported after the first dose through 70 days after the last dose. Standardised incidence rates for malignancies were calculated using a National Cancer Institute database. Standardised death rates were calculated using WHO data. RESULTS: The most frequently reported serious adverse events across indications were infections with greatest incidence in RA and CD trials. Overall malignancy rates for adalimumab-treated patients were as expected for the general population; the incidence of lymphoma was increased in patients with RA, but within the range expected in RA without anti-TNF therapy; non-melanoma skin cancer incidence was raised in RA, Ps and CD. In all indications, death rates were lower than, or equivalent to, those expected in the general population. CONCLUSIONS: Analysis of adverse events of interest through nearly 12 years of adalimumab exposure in clinical trials across indications demonstrated individual differences in rates by disease populations, no new safety signals and a safety profile consistent with known information about the anti-TNF class.

12 Review Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. 2011

Anonymous2160686 / Menter, Alan / Korman, Neil J / Elmets, Craig A / Feldman, Steven R / Gelfand, Joel M / Gordon, Kenneth B / Gottlieb, Alice / Koo, John Y M / Lebwohl, Mark / Leonardi, Craig L / Lim, Henry W / Van Voorhees, Abby S / Beutner, Karl R / Ryan, Caitriona / Bhushan, Reva. ·Psoriasis Research Center, Baylor University Medical Center, Dallas, Texas, USA. ·J Am Acad Dermatol · Pubmed #21306785.

ABSTRACT: Psoriasis is a common, chronic, inflammatory, multisystem disease with predominantly skin and joint manifestations affecting approximately 2% of the population. In the first 5 parts of the American Academy of Dermatology Psoriasis Guidelines of Care, we have presented evidence supporting the use of topical treatments, phototherapy, traditional systemic agents, and biological therapies for patients with psoriasis and psoriatic arthritis. In this sixth and final section of the Psoriasis Guidelines of Care, we will present cases to illustrate how to practically use these guidelines in specific clinical scenarios. We will describe the approach to treating patients with psoriasis across the entire spectrum of this fascinating disease from mild to moderate to severe, with and without psoriatic arthritis, based on the 5 prior published guidelines. Although specific therapeutic recommendations are given for each of the cases presented, it is important that treatment be tailored to meet individual patients' needs. In addition, we will update the prior 5 guidelines and address gaps in research and care that currently exist, while making suggestions for further studies that could be performed to help address these limitations in our knowledge base.

13 Review Anti-p40 antibodies ustekinumab and briakinumab: blockade of interleukin-12 and interleukin-23 in the treatment of psoriasis. 2010

Gandhi, Mona / Alwawi, Eihab / Gordon, Kenneth B. ·Division of Dermatology, NorthShore University HealthSystem, Skokie, IL 60077, USA. ·Semin Cutan Med Surg · Pubmed #20430307.

ABSTRACT: The choice of therapeutic agents for patients with moderate-to-severe psoriasis has expanded significantly in the past decade. With new understanding of the immunologic basis of psoriasis, multiple new potential targets for therapy have been identified. It is likely that a series of new medications to focus on the newly identified pathways is on the horizon. The first pathway targeted by new medications focuses on the p40 subunit that is shared by interleukin (IL)-12 and IL-23. Two human anti-p40 antibodies have been used therapeutically in psoriasis to date, ustekinumab (CNTO-1275, Stelara, Centocor, Horsham, PA) and briakinumab (ABT-874, Abbott, Abbott Park, IL). Ustekinumab was recently approved by the United States Food and Drug Administration, making it the first medication approved in the United States to work by this pathway while briakinumab is currently in phase III clinical trials.

14 Review Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 5. Guidelines of care for the treatment of psoriasis with phototherapy and photochemotherapy. 2010

Menter, Alan / Korman, Neil J / Elmets, Craig A / Feldman, Steven R / Gelfand, Joel M / Gordon, Kenneth B / Gottlieb, Alice / Koo, John Y M / Lebwohl, Mark / Lim, Henry W / Van Voorhees, Abby S / Beutner, Karl R / Bhushan, Reva. ·Psoriasis Research Center, Baylor University Medical Center, Dallas, Texas, USA. ·J Am Acad Dermatol · Pubmed #19811850.

ABSTRACT: Psoriasis is a common, chronic, inflammatory, multisystem disease with predominantly skin and joint manifestations affecting approximately 2% of the population. In this fifth of 6 sections of the guidelines of care for psoriasis, we discuss the use of ultraviolet (UV) light therapy for the treatment of patients with psoriasis. Treatment should be tailored to meet individual patients' needs. We will discuss in detail the efficacy and safety as well as offer recommendations for the use of phototherapy, including narrowband and broadband UVB and photochemotherapy using psoralen plus UVA, alone and in combination with topical and systemic agents. We will also discuss the available data for the use of the excimer laser in the targeted treatment of psoriasis. Finally, where available, we will summarize the available data that compare the safety and efficacy of the different forms of UV light therapy.

15 Review Long-term efficacy of biologics in the treatment of psoriasis: what do we really know? 2009

Alwawi, Eihab A / Krulig, Eliana / Gordon, Kenneth B. ·NorthShore University HealthSystem, Feinberg School of Medicine, Stokie, Illinois 60077, USA. ·Dermatol Ther · Pubmed #19845720.

ABSTRACT: Psoriasis is a chronic inflammatory condition that often requires life-long treatment. Conventional therapies have not fully met the needs of psoriatic patients, because of limited efficacy, adverse effects with cumulative use, and patient inconvenience. In the past decade, biologic immunotherapies have become accepted treatments for psoriasis as a result of perceived efficacy and safety on the part of patients and practitioners. However, most data on these medications come from relatively limited short-term trials. In this review, we will focus on the available long-term data on the efficacy of the biologic agents. We will emphasize the strengths and weakness of the available data of the biologic agents that are Food and Drug Administration (FDA)-approved for the treatment of moderate to severe psoriasis (alefacept, efalizumab,* etanercept, infliximab, and adalimumab), with the inclusion of a newer agent currently under FDA evaluation (ustekinumab).

16 Review AJC editor's consensus: psoriasis and coronary artery disease. 2008

Friedewald, Vincent E / Cather, Jennifer C / Gelfand, Joel M / Gordon, Kenneth B / Gibbons, Gary H / Grundy, Scott M / Jarratt, Michael T / Krueger, James G / Ridker, Paul M / Stone, Neil / Roberts, William C. ·Department of Internal Medicine, The University of Texas Medical School at Houston, Houston, Texas, USA. vfriedew@nd.edu ·Am J Cardiol · Pubmed #19064017.

ABSTRACT: -- No abstract --

17 Clinical Trial Phase 2 Trial of Selective Tyrosine Kinase 2 Inhibition in Psoriasis. 2018

Papp, Kim / Gordon, Kenneth / Thaçi, Diamant / Morita, Akimichi / Gooderham, Melinda / Foley, Peter / Girgis, Ihab G / Kundu, Sudeep / Banerjee, Subhashis. ·From K. Papp Clinical Research and Probity Medical Research, Waterloo (K.P.), the SKiN Centre for Dermatology and Probity Medical Research, Peterborough (M.G.), and Queen's University, Kingston (M.G.) - all in Ontario, Canada · Medical College of Wisconsin, Milwaukee (K.G.) · the University of Luebeck, Luebeck, Germany (D.T.) · Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan (A.M.) · the University of Melbourne, St. Vincent's Hospital Melbourne, Skin and Cancer Foundation, and Probity Medical Research, Melbourne, VIC, Australia (P.F.) · and Bristol-Myers Squibb, Princeton, NJ (I.G.G., S.K., S.B.). ·N Engl J Med · Pubmed #30205746.

ABSTRACT: BACKGROUND: Tyrosine kinase 2 (TYK2) signaling pathways, which mediate cytokine signaling, are implicated in the pathophysiology of psoriasis. Selective inhibitors of TYK2 may be effective in treating psoriasis. METHODS: We conducted a phase 2, double-blind trial of a TYK2 inhibitor, BMS-986165, in adults with moderate-to-severe psoriasis, excluding patients with a previous lack of response to agents targeting cytokine signaling through the same tyrosine kinase pathway. Patients were randomly assigned to receive the drug orally at a dose of 3 mg every other day, 3 mg daily, 3 mg twice daily, 6 mg twice daily, or 12 mg daily or to receive placebo. The primary end point was a 75% or greater reduction from baseline in the Psoriasis Area and Severity Index (PASI) score at week 12 (higher scores indicate greater severity of psoriasis). RESULTS: A total of 267 patients received at least one dose in an intervention group of the trial. At week 12, the percentage of patients with a 75% or greater reduction in the PASI score was 7% (3 of 45 patients) with placebo, 9% (4 of 44 patients) with 3 mg of BMS-986165 every other day (P=0.49 vs. placebo), 39% (17 of 44 patients) with 3 mg daily (P<0.001 vs. placebo), 69% (31 of 45 patients) with 3 mg twice daily (P<0.001 vs. placebo), 67% (30 of 45 patients) with 6 mg twice daily (P<0.001 vs. placebo), and 75% (33 of 44 patients) with 12 mg daily (P<0.001 vs. placebo). There were three serious adverse events in patients receiving the active drug, as well as one case of malignant melanoma 96 days after the start of treatment. CONCLUSIONS: Selective inhibition of TYK2 with the oral agent BMS-986165 at doses of 3 mg daily and higher resulted in greater clearing of psoriasis than did placebo over a period of 12 weeks. Larger and longer-duration trials of this drug are required to determine its safety and durability of effect in patients with psoriasis. (Funded by Bristol-Myers Squibb; ClinicalTrials.gov number, NCT02931838 .).

18 Clinical Trial Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. 2018

Gordon, Kenneth B / Strober, Bruce / Lebwohl, Mark / Augustin, Matthias / Blauvelt, Andrew / Poulin, Yves / Papp, Kim A / Sofen, Howard / Puig, Lluís / Foley, Peter / Ohtsuki, Mamitaro / Flack, Mary / Geng, Ziqian / Gu, Yihua / Valdes, Joaquin M / Thompson, Elizabeth H Z / Bachelez, Hervé. ·Medical College of Wisconsin, Milwaukee, WI, USA. Electronic address: kegordon@mcw.edu. · University of Connecticut Health Center and Probity Medical Research, Farmington, CT, USA. · Icahn School of Medicine at Mount Sinai, New York, NY, USA. · University Medical Center Hamburg-Eppendorf, Hamburg, Germany. · Oregon Medical Research Center, Portland, OR, USA. · Centre Dermatologique du Québec Métropolitain, Québec, QC, Canada. · K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada. · University of California, Los Angeles, CA, USA; School of Medicine, Los Angeles, CA, USA. · Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain. · University of Melbourne, Parkville, Skin & Cancer Foundation Inc, Carlton, Probity Medical Research, Carlton, and St Vincent's Hospital Melbourne, Fitzroy VIC, Australia. · Jichi Medical University, Shimotsuke, Japan. · Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA. · AbbVie, North Chicago, IL, USA. · AbbVie, Redwood City, CA, USA. · Saint-Louis Hospital, AP-HP, Sorbonne Paris Cité Université Paris Diderot, INSERUM UMR 1163, Institut Imagine, Paris, France. Electronic address: herve.bachelez@aphp.fr. ·Lancet · Pubmed #30097359.

ABSTRACT: BACKGROUND: Risankizumab is a humanised IgG1 monoclonal antibody that binds to the p19 subunit of interleukin-23, inhibiting this key cytokine and its role in psoriatic inflammation. We aimed to assess the efficacy and safety of risankizumab compared with placebo or ustekinumab in patients with moderate-to-severe chronic plaque psoriasis. METHODS: UltIMMa-1 and UltIMMa-2 were replicate phase 3, randomised, double-blind, placebo-controlled and active comparator-controlled trials done at 139 sites in Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Japan, Mexico, Poland, Portugal, South Korea, Spain, and the USA. Eligible patients were 18 years or older, with moderate-to-severe chronic plaque psoriasis. In each study, patients were stratified by weight and previous exposure to tumour necrosis factor inhibitor and randomly assigned (3:1:1) by use of interactive response technology to receive 150 mg risankizumab, 45 mg or 90 mg ustekinumab (weight-based per label), or placebo. Following the 16-week double-blind treatment period (part A), patients initially assigned to placebo switched to 150 mg risankizumab at week 16; other patients continued their originally randomised treatment (part B, double-blind, weeks 16-52). Study drug was administered subcutaneously at weeks 0 and 4 during part A and at weeks 16, 28, and 40 during part B. Co-primary endpoints were proportions of patients achieving a 90% improvement in the Psoriasis Area Severity Index (PASI 90) and a static Physician's Global Assessment (sPGA) score of 0 or 1 at week 16 (non-responder imputation). All efficacy analyses were done in the intention-to-treat population. These trials are registered with ClinicalTrials.gov, numbers NCT02684370 (UltIMMa-1) and NCT02684357 (UltIMMa-2), and have been completed. FINDINGS: Between Feb 24, 2016, and Aug 31, 2016, 506 patients in UltIMMa-1 were randomly assigned to receive 150 mg risankizumab (n=304), 45 mg or 90 mg ustekinumab (n=100), or placebo (n=102). Between March 1, 2016, and Aug 30, 2016, 491 patients in UltIMMa-2 were randomly assigned to receive 150 mg risankizumab (n=294), 45 mg or 90 mg ustekinumab (n=99), or placebo (n=98). Co-primary endpoints were met for both studies. At week 16 of UltIMMa-1, PASI 90 was achieved by 229 (75·3%) patients receiving risankizumab versus five (4·9%) receiving placebo (placebo-adjusted difference 70·3% [95% CI 64·0-76·7]) and 42 (42·0%) receiving ustekinumab (ustekinumab-adjusted difference 33·5% [22·7-44·3]; p<0·0001 vs placebo and ustekinumab). At week 16 of UltIMMa-2, PASI 90 was achieved by 220 (74·8%) patients receiving risankizumab versus two (2·0%) receiving placebo (placebo-adjusted difference 72·5% [95% CI 66·8-78·2]) and 47 (47·5%) receiving ustekinumab (ustekinumab-adjusted difference 27·6% [16·7-38·5]; p<0·0001 vs placebo and ustekinumab). In UltIMMa-1, sPGA 0 or 1 at week 16 was achieved by 267 (87·8%) patients receiving risankizumab versus eight (7·8%) receiving placebo (placebo-adjusted difference 79·9% [95% CI 73·5-86·3]) and 63 (63·0%) receiving ustekinumab (ustekinumab-adjusted difference 25·1% [15·2-35·0]; p<0·0001 vs placebo and ustekinumab). In UltIMMa-2, 246 (83·7%) patients receiving risankizumab versus five (5·1%) receiving placebo (placebo-adjusted difference 78·5% [95% CI 72·4-84·5]) and 61 (61·6%) receiving ustekinumab achieved sPGA 0 or 1 at week 16 (ustekinumab-adjusted difference 22·3% [12·0-32·5]; p<0·0001 vs placebo and ustekinumab). The frequency of treatment-emergent adverse events in UltIMMa-1 and UltIMMa-2 was similar across risankizumab (part A: 151 [49·7%] of 304 and 134 [45·6%] of 294; part B: 182 [61·3%] of 297 and 162 [55·7%] of 291), placebo (part A: 52 [51·0%] of 102 and 45 [45·9%] of 98), ustekinumab (part A: 50 [50·0%] of 100 and 53 [53·5%] of 99; part B: 66 [66·7%] of 99 and 70 [74·5%] of 94), and placebo to risankizumab (part B: 65 [67·0%] of 97 and 61 [64·9%] of 94) treatment groups throughout the study duration. INTERPRETATION: Risankizumab showed superior efficacy to both placebo and ustekinumab in the treatment of moderate-to-severe plaque psoriasis. Treatment-emergent adverse event profiles were similar across treatment groups and there were no unexpected safety findings. FUNDING: AbbVie and Boehringer Ingelheim.

19 Clinical Trial Anxiety and depression in patients with moderate-to-severe psoriasis and comparison of change from baseline after treatment with guselkumab vs. adalimumab: results from the Phase 3 VOYAGE 2 study. 2018

Gordon, K B / Armstrong, A W / Han, C / Foley, P / Song, M / Wasfi, Y / You, Y / Shen, Y-K / Reich, K. ·Medical College of Wisconsin, Milwaukee, WI, USA. · University of Southern California, Los Angeles, CA, USA. · Janssen Research & Development, LLC, Spring House, PA, USA. · The University of Melbourne, St. Vincent's Hospital Melbourne, Skin & Cancer Foundation Inc., Carlton, VIC, Australia. · Dermatologikum Berlin, Berlin, Germany. ·J Eur Acad Dermatol Venereol · Pubmed #29706008.

ABSTRACT: BACKGROUND: Anxiety and depression are clinically significant comorbidities associated with psoriasis. Improvements in psoriasis are known to decrease anxiety and depression. Guselkumab, an anti-interleukin-23 monoclonal antibody, has demonstrated efficacy and safety for the treatment of moderate-to-severe psoriasis. OBJECTIVE: Assess improvements in anxiety and depression with guselkumab vs. placebo and adalimumab using the Hospital Anxiety and Depression Scale (HADS). METHODS: In VOYAGE 2, a Phase 3, randomized, double-blind, placebo- and adalimumab-controlled study, patients received placebo (through week 16 followed by crossover to guselkumab), guselkumab, or adalimumab through week 24. HADS consists of two subscales measuring anxiety (HADS-A) and depression (HADS-D), with scores ranging from 0 to 21 and higher scores indicating more severe symptoms. Scores ≥8 indicate instrument-defined anxiety or depression. Severity of psoriasis was assessed using the Psoriasis Area and Severity Index (PASI). RESULTS: Among 989 patients randomized (with baseline HADS measurements), mean HADS-A and HADS-D scores were 6.8 ± 4.2 and 5.3 ± 4.2, respectively; 38.6% of patients reported HADS-A ≥8 and 27.7% HADS-D ≥8 at baseline. At week 16, a significantly greater proportion of guselkumab patients with baseline HADS-A or HADS-D ≥8 reported HADS-A <8 (51.4% vs. 25.9%; P < 0.001) or HADS-D <8 (59.2% vs. 27.0%; P < 0.001) vs. placebo patients. At week 24, a greater proportion of guselkumab patients with baseline HADS-A or HADS-D ≥8 reported HADS-A <8 (58.4% vs. 42.9%; P = 0.028) or HADS-D <8 (59.8% vs. 46.4%; P = 0.079) vs. adalimumab patients. PASI improvements correlated with improvement in anxiety (r = 0.27; P < 0.0001) and depression (r = 0.25; P < 0.0001) scores in patients with baseline HADS-A or HADS-D ≥8. Greater improvements in HADS were also observed at week 16 in guselkumab-treated patients vs. placebo using a more stringent cut-off of HADS ≥11. CONCLUSION: Guselkumab treatment was associated with greater improvements in symptoms of anxiety and depression scores in patients with psoriasis compared with placebo and adalimumab.

20 Clinical Trial Efficacy and safety of ixekizumab over 4 years of open-label treatment in a phase 2 study in chronic plaque psoriasis. 2018

Zachariae, Claus / Gordon, Kenneth / Kimball, Alexandra B / Lebwohl, Mark / Blauvelt, Andrew / Leonardi, Craig / Braun, Daniel / McKean-Matthews, Missy / Burge, Russel / Cameron, Gregory. ·University Hospital of Copenhagen Gentofte, Copenhagen, Denmark. Electronic address: claus.zachariae@regionh.dk. · Medical College of Wisconsin, Milwaukee, Wisconsin. · Harvard Medical School, Boston, Massachusetts. · Mount Sinai Medical Center, New York, New York. · Oregon Medical Research Center, Portland, Oregon. · Department of Dermatology, Saint Louis University School of Medicine, St. Louis, Missouri. · Eli Lilly and Company, Indianapolis, Indiana. · Syneos Health, Ann Arbor, Michigan. ·J Am Acad Dermatol · Pubmed #29653208.

ABSTRACT: BACKGROUND: Ixekizumab has demonstrated improvement in patients with moderate-to-severe psoriasis by selectively targeting interleukin-17A, which is a proinflammatory cytokine that is important in the pathogenesis of psoriasis. OBJECTIVE: To report 4-year efficacy and safety results from the open-label extension (OLE) of this phase 2 trial. METHODS: Analysis was by last observation carried forward. Patients received ixekizumab, 120 mg, and then 80 mg subcutaneously once every 4 weeks. RESULTS: Of the patients who completed the randomized placebo-controlled trial, 93% entered the OLE. A 75% reduction in the Psoriasis Area Severity Index score was reported in 82% of patients at week 208 of the OLE. A static Physician's Global Assessment score of 0 or 1 was reported in 64% of patients, and a score of 0 was reported in 45% at week 208. Patients' Dermatology Life Quality Index and Itch Visual Analog Scale scores decreased when compared with baseline. Improvements were observed in other efficacy and health outcome measures. Serious adverse events were observed in 16.7% of patients, and 87% had 1 or more treatment-emergent adverse events. Three patients had serious infections. One patient reported 2 major cardiovascular events. LIMITATIONS: The study was unblinded and lacked a placebo or active comparator. CONCLUSIONS: Efficacy was shown to be maintained for up to 4 years of ixekizumab treatment.

21 Clinical Trial Efficacy of guselkumab in subpopulations of patients with moderate-to-severe plaque psoriasis: a pooled analysis of the phase III VOYAGE 1 and VOYAGE 2 studies. 2018

Gordon, K B / Blauvelt, A / Foley, P / Song, M / Wasfi, Y / Randazzo, B / Shen, Y K / You, Y / Griffiths, C E M. ·Medical College of Wisconsin, Milwaukee, WI, U.S.A. · Oregon Medical Research Center, Portland, OR, U.S.A. · The University of Melbourne, St Vincent's Hospital, Melbourne, Australia. · Skin & Cancer Foundation Inc., Carlton, Victoria, Australia. · Janssen Research & Development, LLC, Spring House, PA, U.S.A. · The Dermatology Centre, Salford Royal Hospital, The University of Manchester, Manchester Academic Health Science Centre, Manchester, U.K. ·Br J Dermatol · Pubmed #28940259.

ABSTRACT: BACKGROUND: Significant advances have been made in the treatment of moderate-to-severe plaque psoriasis with biological therapies; however, these agents may not work equally in all populations. OBJECTIVES: To evaluate the efficacy of guselkumab in patient subgroups with moderate-to-severe psoriasis from the pooled guselkumab VOYAGE 1 and VOYAGE 2 phase III studies. METHODS: Using data from the pooled VOYAGE 1 and VOYAGE 2 psoriasis studies, analyses were performed to evaluate the consistency of efficacy [Investigator's Global Assessment (IGA) 0/1 (cleared or minimal psoriasis) and IGA 0 (cleared)] across subpopulations defined by demographics, baseline disease characteristics and previous psoriasis treatment. RESULTS: A total of 1829 patients were randomized. Baseline demographics, disease characteristics and previous psoriasis treatment were comparable across treatment groups in the pooled population. Guselkumab, an anti-interleukin (IL)-23 monoclonal antibody that binds to the p19 subunit of IL-23, provided substantial benefit across almost all subpopulations, with greater proportions of patients achieving IGA 0/1 vs. placebo at week 16, and vs. adalimumab (an antitumour necrosis factor monoclonal antibody) at week 24. Patients treated with guselkumab achieved greater efficacy (IGA 0/1 and IGA 0) compared with adalimumab at week 24 across all weight quartiles, most notably among patients weighing ≥ 100 kg. CONCLUSIONS: This analysis demonstrates a high degree of efficacy with guselkumab treatment compared with placebo at week 16 and with adalimumab at week 24 among broad subpopulations of patients with varying baseline demographics, disease characteristics and previous psoriasis treatments.

22 Clinical Trial Poor early response to methotrexate portends inadequate long-term outcomes in patients with moderate-to-severe psoriasis: Evidence from 2 phase 3 clinical trials. 2017

Gordon, Kenneth B / Betts, Keith A / Sundaram, Murali / Signorovitch, James E / Li, Junlong / Xie, Meng / Wu, Eric Q / Okun, Martin M. ·Medical College of Wisconsin, Milwaukee, Wisconsin. · Analysis Group Inc, Boston, Massachusetts. Electronic address: keith.betts@analysisgroup.com. · AbbVie Inc, North Chicago, Illinois. · Analysis Group Inc, Boston, Massachusetts. · AbbVie Inc, North Chicago, Illinois; Fort HealthCare, Fort Atkinson, Wisconsin. ·J Am Acad Dermatol · Pubmed #28993007.

ABSTRACT: BACKGROUND: Most methotrexate-treated psoriasis patients do not achieve a long-term PASI75 (75% reduction from baseline Psoriasis Area and Severity Index score) response. Indications of nonresponse can be apparent after only 4 weeks of treatment. OBJECTIVE: To develop a prediction rule to identify patients unlikely to respond adequately to methotrexate. METHODS: Patient-level data from CHAMPION (NCT00235820, N = 110) was used to construct a prediction model for week 16 PASI75 by using patient baseline characteristics and week 4 PASI25. A prediction rule was determined on the basis of the sensitivity and specificity and validated in terms of week 16 PASI75 response in an independent validation sample from trial M10-255 (NCT00679731, N = 163). RESULTS: PASI25 achievement at week 4 (odds ratio = 8.917) was highly predictive of response with methotrexate at week 16. Patients with a predicted response probability <30% were recommended to discontinue methotrexate. The rates of week 16 PASI75 response were 65.8% and 21.1% (P < .001) for patients recommended to continue and discontinue methotrexate, respectively. LIMITATIONS: The CHAMPION trial excluded patients previously treated with biologics, and the M10-255 trial had no restrictions. CONCLUSION: A prediction rule was developed and validated to identify patients unlikely to respond adequately to methotrexate. The rule indicates that 4 weeks of methotrexate might be sufficient to predict long-term response with limited safety risk.

23 Clinical Trial Continuous dosing versus interrupted therapy with ixekizumab: an integrated analysis of two phase 3 trials in psoriasis. 2017

Blauvelt, A / Papp, K A / Sofen, H / Augustin, M / Yosipovitch, G / Katoh, N / Mrowietz, U / Ohtsuki, M / Poulin, Y / Shrom, D / Burge, R / See, K / Mallbris, L / Gordon, K B. ·Oregon Medical Research Center, Portland, OR, USA. · Probity Medical Research and K. Papp Clinical Research, Waterloo, ON, Canada. · Department of Medicine (Dermatology), David Geffen School of Medicine, Los Angeles, CA, USA. · Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg, Hamburg, Germany. · Department of Dermatology, Miller School of Medicine, University of Miami, Miami, FL, USA. · Department of Dermatology, Kyoto Prefectural University of Medicine Graduate School of Medical Science, Kyoto, Japan. · Psoriasis-Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Germany. · Department of Dermatology, Jichi Medical University, Shimotsuke, Tochigi, Japan. · Department of Medicine, Université Laval, Hôpital Hôtel-Dieu de Québec, Quebec, QC, Canada. · Centre de Recherche Dermatologique du Québec Métropolitain, Quebec, QC, Canada. · Eli Lilly and Company, Indianapolis, IN, USA. · Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. ·J Eur Acad Dermatol Venereol · Pubmed #28190255.

ABSTRACT: BACKGROUND: Continuous treatment is recommended for patients with moderate-to-severe psoriasis; however, treatment may need to be interrupted in routine clinical practice. OBJECTIVE: To assess outcomes in patients continuously treated with ixekizumab versus those who interrupted therapy and were subsequently retreated with ixekizumab (IXE). METHODS: This analysis used data pooled from two phase 3 trials, UNCOVER-1 and UNCOVER-2. Patients were randomized to placebo (PBO), IXE every 4 (Q4W) or IXE every 2 weeks (Q2W) for 12 weeks. Patients with a static Physician's Global Assessment (sPGA) 0, 1 at Week 12 were rerandomized to IXEQ4W, IXE every 12 weeks (not presented) or PBO. We examined outcomes in patients who were continuously treated (IXEQ2W/IXEQ4W; IXEQ4W/IXEQ4W) or withdrawn (IXEQ2W/PBO; IXEQ4W/PBO), and in patients who were withdrawn and retreated with IXEQ4W for 24 weeks after disease relapse (sPGA ≥3). RESULTS: A total of 1226 treated patients achieved an sPGA 0, 1 at Week 12 and entered the maintenance phase; of these patients, 402 and 416 were rerandomized to PBO and IXEQ4W, respectively. Among patients interrupting treatment, 157 (82.2%) of IXEQ4W/PBO and 176 (83.4%) of IXEQ2W/PBO had an sPGA ≥3 by Week 60; median time to relapse was approximately 20 weeks irrespective of induction dose. At Week 60, continuously treated patients maintained high levels of PASI and sPGA responses (90.0% PASI 75 IXEQ2W/IXEQ4W; 81.9% sPGA 0, 1 IXEQ2W/IXEQ4W, non-responder imputation). After 24 weeks of retreatment with IXEQ4W (IXEQ2W/PBO/IXEQ4W and IXEQ4W/PBO/IXEQ4W), 87.0% (107 of 123) and 95.1% (97 of 102) (observed), respectively, of patients recaptured PASI 75 and 70.7% (104 of 147) and 82.3% (107 of 130) (observed) recaptured an sPGA 0, 1. Overall, adverse events in continuously treated and retreated patients were comparable. CONCLUSION: High levels of response were sustained with continuous ixekizumab treatment through 60 weeks. Most patients who were withdrawn experienced disease relapse, and most of those patients recaptured response after 24 weeks of retreatment.

24 Clinical Trial Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: Results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. 2017

Reich, Kristian / Armstrong, April W / Foley, Peter / Song, Michael / Wasfi, Yasmine / Randazzo, Bruce / Li, Shu / Shen, Y-K / Gordon, Kenneth B. ·Dermatologikum Hamburg and SCIderm Research Institute, Hamburg, Germany. Electronic address: kreich@dermatologikum.de. · University of Southern California, Los Angeles, California. · University of Melbourne, St Vincent's Hospital, Melbourne, Australia; Skin and Cancer Foundation Inc, Carlton, Australia. · Janssen Research & Development, LLC, Spring House, Pennsylvania. · Northwestern University, Feinberg School of Medicine, Chicago, Illinois. ·J Am Acad Dermatol · Pubmed #28057361.

ABSTRACT: BACKGROUND: Phase II data suggested that guselkumab, an anti-interleukin-23 monoclonal antibody, was efficacious in psoriasis. OBJECTIVE: We sought to assess efficacy and safety of guselkumab in moderate to severe psoriasis versus placebo and adalimumab, including interrupted treatment and switching adalimumab nonresponders to guselkumab. METHODS: Patients were randomized to guselkumab 100 mg (weeks 0 and 4, then every 8 weeks; n = 496); placebo→guselkumab (weeks 0, 4, and 12 then guselkumab at weeks 16 and 20; n = 248); or adalimumab (80 mg week 0, then 40 mg week 1, and every 2 weeks through week 23; n = 248). At week 28, guselkumab 90% or greater improvement in Psoriasis Area and Severity Index (PASI) score from baseline (PASI 90) responders were rerandomized to guselkumab or placebo with guselkumab after loss of response. Placebo→guselkumab responders and adalimumab responders received placebo, then guselkumab after loss of response. Nonresponders received guselkumab. RESULTS: At week 16, more patients receiving guselkumab achieved an Investigator Global Assessment (IGA) score 0/1 (cleared/minimal) (84.1% vs 8.5%) and PASI 90 (70.0% vs 2.4%) versus placebo (coprimary end points). Guselkumab was superior to adalimumab at week 16 (IGA score 0/1, 75% or greater improvement in PASI score from baseline, and PASI 90) and week 24 (IGA score 0/1 and 0, PASI 90, 100% improvement in PASI score from baseline) (P < .001). From weeks 28 to 48, better persistence of response was observed in guselkumab maintenance versus withdrawal groups (P < .001). Of adalimumab nonresponders who switched to guselkumab, 66.1% achieved PASI 90 at week 48. Guselkumab improved patient-reported outcomes. Adverse events were comparable among groups. LIMITATIONS: One-year follow-up limits retreatment data. CONCLUSIONS: Guselkumab is a highly effective, well-tolerated, maintenance therapy, including in adalimumab nonresponders.

25 Clinical Trial Early clinical response to tofacitinib treatment as a predictor of subsequent efficacy: Results from two phase 3 studies of patients with moderate-to-severe plaque psoriasis. 2017

Tan, Huaming / Valdez, Hernan / Griffins, Chris E M / Mrowietz, Ulrich / Tallman, Anna / Wolk, Robert / Gordon, Kenneth. ·a Global Medicines Development, Global Innovative Pharma, Pfizer Inc , Groton , CT , USA. · b Global Medical Affairs, Global Innovative Pharma, Pfizer Inc. , New York , NY , USA. · c The Dermatology Centre , Salford Royal NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre , Manchester , UK. · d Psoriasis-Center at the Department of Dermatology , University Medical Center Schleswig-Holstein , Campus Kiel , Germany. · e Department of Dermatology, Feinberg School of Medicine , Northwestern University , Chicago , IL , USA. ·J Dermatolog Treat · Pubmed #27538247.

ABSTRACT: BACKGROUND: The ability to predict response to psoriasis treatments has important implications. Tofacitinib is an oral JAK inhibitor being investigated for psoriasis. OBJECTIVE: The objective of this study is to identify and validate the clinical predictors of responses in psoriasis patients treated with tofacitinib. METHODS: Selected baseline characteristics or early improvement in Psoriasis Area and Severity Index (PASI) in the phase 3 tofacitinib study OPT 1 (NCT01276639) were evaluated as predictors for a clinical response (75% improvement in PASI [PASI75]) at week 16. Predictive ability was assessed by the area-under-the-receiver operating characteristic curve (AUC-ROC). The predictive ability of the identified variables was validated with study OPT 2 (NCT01309737). RESULTS: PASI improvement at weeks 8 and 12 demonstrated good discriminatory abilities to predict PASI75 response at week 16 (AUC-ROC ≥86% and 94%, respectively) in OPT 1. Validation with PASI50 response at week 8 in OPT 2 to predict PASI75 response at week 16 showed that the sensitivity, specificity, PPV, and NPV were 88%, 69%, 80%, and 81%, respectively, in tofacitinib-treated subjects. CONCLUSION: Achieving a PASI50 response after 8 weeks of treatment with tofacitinib in psoriasis patients appears to be a reliable predictor of achieving a PASI75 response at week 16. TRIAL REGISTRATION: clinicaltrials.gov: NCT01276639 and NCT01309737.

Next