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Psoriasis: HELP
Articles from Metroplex Clinical Research Center
Based on 4 articles published since 2010
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These are the 4 published articles about Psoriasis that originated from Metroplex Clinical Research Center during 2010-2020.
 
+ Citations + Abstracts
1 Review The efficacy and safety of golimumab in the treatment of arthritis. 2010

Fleischmann, Roy. ·University of Texas Southwestern Medical School, Metroplex Clinical Research Center, 8144 Walnut Hill Lane, Suite 800, Dallas, Texas 75231, USA. rfleischmann@arthdocs.com ·Expert Opin Biol Ther · Pubmed #20504106.

ABSTRACT: IMPORTANCE OF THE FIELD: Twenty-five years ago, rheumatoid arthritis (RA) was a relentless disease, treated symptomatically because of the lack of effective, well tolerated medications which could halt disease in most patients. The introduction of methotrexate, sulfasalazine and leflunomide, and aggressive treatment, changed the prognosis of RA in the 1990s. Biologic therapies have dramatically changed the long-term prognosis of patients with rheumatoid and psoriatic arthritis and ankylosing spondylitis. AREAS COVERED IN THIS REVIEW: Unfortunately, no one single agent is fully effective in every patient. For this reason, another agent, golimumab (GLM), a TNF-alpha inhibitor (TNF-I) was developed. The basis of this review is all peer-reviewed manuscripts on GLM in the treatment of RA, psoriatic arthritis (PsA) and ankylosing spondylitis (AS) found in Pub Med. and Medline from 2000 to 2010 and abstracts presented at the major rheumatology congresses within the past five years. WHAT THE READER WILL GAIN: This review describes the efficacy and safety of GLM and should enable an understanding of the benefit-risk profile of GLM in the treatment of RA, PsA and AS. TAKE HOME MESSAGE: GLM is effective and has a safety profile similar to other TNF-I in the treatment of RA, AS and PsA.

2 Clinical Trial Cutting Edge: Selective Oral ROCK2 Inhibitor Reduces Clinical Scores in Patients with Psoriasis Vulgaris and Normalizes Skin Pathology via Concurrent Regulation of IL-17 and IL-10. 2017

Zanin-Zhorov, Alexandra / Weiss, Jonathan M / Trzeciak, Alissa / Chen, Wei / Zhang, Jingya / Nyuydzefe, Melanie S / Arencibia, Carmen / Polimera, Seetharam / Schueller, Olivier / Fuentes-Duculan, Judilyn / Bonifacio, Kathleen M / Kunjravia, Norma / Cueto, Inna / Soung, Jennifer / Fleischmann, Roy M / Kivitz, Alan / Lebwohl, Mark / Nunez, Margarita / Woodson, Johnnie / Smith, Shondra L / West, Robert F / Berger, Mark / Krueger, James G / Ryan, John L / Waksal, Samuel D. ·Kadmon Corporation, LLC, New York, NY 10016; alexandra.zanin-zhorov@kadmon.com. · Kadmon Corporation, LLC, New York, NY 10016. · Laboratory for Investigative Dermatology, Rockefeller University, New York, NY 10065. · Southern California Dermatology, Inc., Santa Ana, CA 92701. · Metroplex Clinical Research Center, Dallas, TX 75231. · Altoona Center for Clinical Research, Duncanville, PA 16635. · Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY 10029. · High Point Clinical Trials Center, High Point, NC 27265. · Clinical Studies Group, LLC, Henderson, NV 89074. · Dermatology & Advanced Aesthetics, Lake Charles, LA 70605; and. · Arrowhead Health Centers, Glendale, AZ 85306. ·J Immunol · Pubmed #28389592.

ABSTRACT: Targeted inhibition of Rho-associated kinase (ROCK)2 downregulates the proinflammatory T cell response while increasing the regulatory arm of the immune response in animals models of autoimmunity and Th17-skewing human cell culture in vitro. In this study, we report that oral administration of a selective ROCK2 inhibitor, KD025, reduces psoriasis area and severity index scores by 50% from baseline in 46% of patients with psoriasis vulgaris, and it decreases epidermal thickness as well as T cell infiltration in the skin. We observed significant reductions of IL-17 and IL-23, but not IL-6 and TNF-α, whereas IL-10 levels were increased in peripheral blood of clinical responders after 12 wk of treatment with KD025. Collectively, these data demonstrate that an orally available selective ROCK2 inhibitor downregulates the Th17-driven autoimmune response and improved clinical symptoms in psoriatic patients via a defined molecular mechanism that involves concurrent modulation of cytokines without deleterious impact on the rest of the immune system.

3 Clinical Trial A Phase III, Randomized, Controlled Trial of Apremilast in Patients with Psoriatic Arthritis: Results of the PALACE 2 Trial. 2016

Cutolo, Maurizio / Myerson, Gary E / Fleischmann, Roy M / Lioté, Frédéric / Díaz-González, Federico / Van den Bosch, Filip / Marzo-Ortega, Helena / Feist, Eugen / Shah, Kamal / Hu, ChiaChi / Stevens, Randall M / Poder, Airi. ·From the Research Laboratory and Division of Clinical Rheumatology, University of Genoa, Genoa, Italy; Arthritis and Rheumatology of Georgia, Atlanta, Georgia; Metroplex Clinical Research Center, Dallas, Texas, USA; AP-HP, Hôpital Lariboisière, Rheumatology Department, Université Paris Diderot, Paris, France; University of La Laguna, Hospital Universitario de Canarias, La Laguna, Spain; UZ Gent, Ghent, Belgium; UK National Institute for Health Research (NIHR) Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; Charité - Universitätsmedizin Berlin, Department for Rheumatology and Clinical Immunology, Berlin, Germany; Celgene Corp., Summit, New Jersey, USA; Clinical Research Centre Ltd., Tartu, Estonia.M. Cutolo, MD, University of Genoa; G.E. Myerson, MD, Arthritis and Rheumatology of Georgia; R.M. Fleischmann, MD, Metroplex Clinical Research Center; F. Lioté, MD, AP-HP, Hôpital Lariboisière, Université Paris Diderot; F. Diaz-González, MD, University of La Laguna, Hospital Universitario de Canarias; F. Van den Bosch, MD, UZ Gent; H. Marzo-Ortega, MD, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; E. Feist, MD, Charité - Universitätsmedizin Berlin; K. Shah, MD, Celgene Corp.; C. Hu, EdM, MS, Celgene Corp.; R.M. Stevens, MD, Celgene Corp.; A. Poder, MD, Clinical Research Centre Ltd. ·J Rheumatol · Pubmed #27422893.

ABSTRACT: OBJECTIVE: Apremilast, an oral phosphodiesterase 4 inhibitor, downregulates intracellular inflammatory mediator synthesis by elevating cyclic adenosine monophosphate levels. The PALACE 2 trial evaluated apremilast efficacy and safety in patients with active psoriatic arthritis (PsA) despite prior conventional disease-modifying antirheumatic drugs and/or biologic therapy. METHODS: Eligible patients were randomized (1:1:1) to placebo, apremilast 20 mg BID, or apremilast 30 mg BID. At Week 16, patients with swollen and tender joint count improvement < 20% entered early escape, with placebo patients rerandomized (1:1) to apremilast 20 mg BID or 30 mg BID while apremilast patients continued on their initial apremilast dose. At Week 24, patients remaining on placebo were rerandomized to apremilast 20 mg BID or 30 mg BID. The primary endpoint was the proportion of patients achieving > 20% improvement in American College of Rheumatology response criteria (ACR20) at Week 16. RESULTS: In the intent-to-treat population (N = 484), ACR20 at Week 16 was achieved by more patients receiving apremilast 20 mg BID [37.4% (p = 0.0002)] and 30 mg BID [32.1% (p = 0.0060)] versus placebo (18.9%). Clinically meaningful improvements in signs and symptoms of PsA, physical function, and psoriasis were observed with apremilast through Week 52. The most common adverse events were diarrhea, nausea, headache, and upper respiratory tract infection. Diarrhea and nausea generally occurred early and usually resolved spontaneously with continued treatment. Laboratory abnormalities were infrequent and transient. CONCLUSION: Apremilast demonstrated clinical improvements in PsA for up to 52 weeks, including signs and symptoms, physical function, and psoriasis. No new safety signals were observed. ClinicalTrials.gov identifier: NCT01212757.

4 Article Five-year Safety Data from 5 Clinical Trials of Subcutaneous Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis. 2016

Kay, Jonathan / Fleischmann, Roy / Keystone, Edward / Hsia, Elizabeth C / Hsu, Benjamin / Zhou, Yiying / Goldstein, Neil / Braun, Jürgen. ·From the Division of Rheumatology, Department of Medicine, UMass Memorial Medical Center, and University of Massachusetts Medical School, Worcester, Massachusetts; Rheumatology, University of Texas Southwestern Medical Center and Metroplex Clinical Research Center, Dallas, Texas; Janssen Research and Development LLC, Spring House; University of Pennsylvania, Philadelphia, Pennsylvania, USA; Division of Rheumatology, University of Toronto, Toronto, Ontario, Canada; Rheumatology, Rheumazentrum Ruhrgebeit, Herne, Germany. jonathan.kay@umassmemorial.org. · J. Kay, MD, Division of Rheumatology, and Department of Medicine, UMass Memorial Medical Center, University of Massachusetts Medical School; R. Fleischmann, MD, Rheumatology, University of Texas Southwestern Medical Center, and Metroplex Clinical Research Center; E. Keystone, MD, FRCP(C), Division of Rheumatology, University of Toronto; E.C. Hsia, MD, Janssen Research and Development LLC, and University of Pennsylvania; B. Hsu, MD, PhD, Janssen Research and Development LLC, and University of Pennsylvania; Y. Zhou, PhD, Janssen Research and Development LLC; N. Goldstein, MD, Janssen Research and Development LLC; J. Braun, MD, Rheumatology, Rheumazentrum Ruhrgebeit. jonathan.kay@umassmemorial.org. · From the Division of Rheumatology, Department of Medicine, UMass Memorial Medical Center, and University of Massachusetts Medical School, Worcester, Massachusetts; Rheumatology, University of Texas Southwestern Medical Center and Metroplex Clinical Research Center, Dallas, Texas; Janssen Research and Development LLC, Spring House; University of Pennsylvania, Philadelphia, Pennsylvania, USA; Division of Rheumatology, University of Toronto, Toronto, Ontario, Canada; Rheumatology, Rheumazentrum Ruhrgebeit, Herne, Germany. · J. Kay, MD, Division of Rheumatology, and Department of Medicine, UMass Memorial Medical Center, University of Massachusetts Medical School; R. Fleischmann, MD, Rheumatology, University of Texas Southwestern Medical Center, and Metroplex Clinical Research Center; E. Keystone, MD, FRCP(C), Division of Rheumatology, University of Toronto; E.C. Hsia, MD, Janssen Research and Development LLC, and University of Pennsylvania; B. Hsu, MD, PhD, Janssen Research and Development LLC, and University of Pennsylvania; Y. Zhou, PhD, Janssen Research and Development LLC; N. Goldstein, MD, Janssen Research and Development LLC; J. Braun, MD, Rheumatology, Rheumazentrum Ruhrgebeit. ·J Rheumatol · Pubmed #27803138.

ABSTRACT: OBJECTIVE: Assess 5-year golimumab (GOL) safety in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). METHODS: Subcutaneous (SC) GOL (50 mg or 100 mg every 4 weeks) was evaluated in phase 3 trials of patients with active RA, PsA, and AS. Safety data through Year 5 were pooled across 3 RA trials [1 each evaluating methotrexate (MTX)-naive, MTX-experienced, and antitumor necrosis factor (TNF)-experienced patients], 1 PsA trial, and 1 AS trial. Data summarized was derived from both placebo-controlled (through weeks 24-52) and uncontrolled study periods. For adverse events (AE) of special interest [serious infections (SI), opportunistic infections (OI), deaths, malignancies, demyelination, tuberculosis (TB)], incidence per 100 patient-years (pt-yrs) was determined. RESULTS: Across all trials, 639 patients received placebo and 2228 received SC GOL 50 mg only (n = 671), 50 mg and 100 mg (n = 765), or 100 mg only (n = 792). Safety followup extended for averages of 28.5 and 203.2 weeks for placebo and GOL, respectively. Respective placebo and GOL AE incidence/100 pt-yrs (95% CI) through Year 5 were 4.86 (2.83-7.78) and 3.29 (2.92-3.69) for SI, 0.00 (0.00-0.86) and 0.23 (0.14-0.35) for TB, 0.00 (0.00-0.86) and 0.22 (0.13-0.34) for OI, 0.00 (0.00-0.86) and 0.10 (0.05-0.20) for lymphoma, 0.00 (0.00-0.86) and 0.08 (0.03-0.17) for demyelination, and 0.29 (0.01-1.59) and 0.41 (0.29-0.57) for death. TB, OI, lymphoma, and demyelination incidence appeared to be higher among patients receiving GOL 100 mg only. CONCLUSION: SC GOL safety through Year 5 remained consistent with previously reported Year 3 findings and with other TNF antagonists. Numerically higher incidences of TB, OI, lymphoma, and demyelination were observed with 100 mg versus 50 mg. Clinicaltrials.gov identifiers: NCT00264537 (GO-BEFORE), NCT00264550 (GO-FORWARD), NCT00299546 (GO-AFTER), NCT00265096 (GO-REVEAL), and NCT00265083 (GO-RAISE).