Philip J Mease1, Alexis Ogdie2, Soumya D Chakravarty3,4, Natalie J Shiff3,5, Iris Lin3, Robert R McLean6, Wendi Malley6, Rebecca L Spitzer6, Arthur Kavanaugh7, Joseph F Merola8. 1. Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, 601 Broadway, Suite 600, Seattle, WA, 98122, USA. pmease@philipmease.com. 2. University of Pennsylvania School of Medicine, Philadelphia, PA, USA. 3. Janssen Scientific Affairs, LLC, Horsham, PA, USA. 4. Drexel University College of Medicine, Philadelphia, PA, USA. 5. Adjunct, Department of Community Health and Epidemiology, College of Medicine, University of Saskatchewan, Saskatoon, SK, Canada. 6. CorEvitas, LLC, Waltham, MA, USA. 7. University of California San Diego, La Jolla, CA, USA. 8. Brigham and Women's Hospital, Department of Medicine, Division of Rheumatology, Inflammation, and Immunity, Department of Dermatology, Harvard Medical School, Boston, MA, USA.
Abstract
BACKGROUND: The monoclonal antibody guselkumab is the first selective inhibitor of the interleukin-23 p19 subunit approved to treat adults with moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA). Given its recent approval for active PsA, data describing patients with PsA initiating guselkumab outside of clinical trials are limited. OBJECTIVE: This analysis describes characteristics of patients with rheumatologist-diagnosed PsA initiating guselkumab in the US-based, prospective, observational CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry. METHODS: Demographics, lifestyle/disease characteristics, comorbidities, prior treatment, and disease activity were summarized for patients with PsA initiating guselkumab from registry inception through 30 September, 2021. RESULTS: Of 113 patients initiating guselkumab, the majority were female (63%), obese (67%), had psoriasis (89%), and initiated guselkumab as monotherapy (81%). Common comorbidities were hypertension (32%), depression (30%), and diabetes mellitus (26%). Mean tender (6.8) and swollen (2.0) joint counts, clinical Disease Activity Index for PsA score (19.1), and 57% of participants with ≥ 3% body surface area affected by psoriasis indicated moderate disease activity. Axial involvement was identified in 49% of patients. Median patient-reported pain and fatigue visual analog scale scores (0-100) were 60 and 59, respectively. Prior to guselkumab, 76% of patients had received two or more biologic disease-modifying antirheumatic drugs; the last therapy prior to guselkumab was a biologic disease-modifying antirheumatic drug in 81% of patients. CONCLUSIONS: Registry participants with PsA initiating guselkumab had active peripheral joint and skin disease, with substantial pain and fatigue; a considerable proportion had axial involvement. Future studies will evaluate the effectiveness of guselkumab in this population.
BACKGROUND: The monoclonal antibody guselkumab is the first selective inhibitor of the interleukin-23 p19 subunit approved to treat adults with moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA). Given its recent approval for active PsA, data describing patients with PsA initiating guselkumab outside of clinical trials are limited. OBJECTIVE: This analysis describes characteristics of patients with rheumatologist-diagnosed PsA initiating guselkumab in the US-based, prospective, observational CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry. METHODS: Demographics, lifestyle/disease characteristics, comorbidities, prior treatment, and disease activity were summarized for patients with PsA initiating guselkumab from registry inception through 30 September, 2021. RESULTS: Of 113 patients initiating guselkumab, the majority were female (63%), obese (67%), had psoriasis (89%), and initiated guselkumab as monotherapy (81%). Common comorbidities were hypertension (32%), depression (30%), and diabetes mellitus (26%). Mean tender (6.8) and swollen (2.0) joint counts, clinical Disease Activity Index for PsA score (19.1), and 57% of participants with ≥ 3% body surface area affected by psoriasis indicated moderate disease activity. Axial involvement was identified in 49% of patients. Median patient-reported pain and fatigue visual analog scale scores (0-100) were 60 and 59, respectively. Prior to guselkumab, 76% of patients had received two or more biologic disease-modifying antirheumatic drugs; the last therapy prior to guselkumab was a biologic disease-modifying antirheumatic drug in 81% of patients. CONCLUSIONS: Registry participants with PsA initiating guselkumab had active peripheral joint and skin disease, with substantial pain and fatigue; a considerable proportion had axial involvement. Future studies will evaluate the effectiveness of guselkumab in this population.
Authors: Iain B McInnes; Proton Rahman; Alice B Gottlieb; Elizabeth C Hsia; Alexa P Kollmeier; Soumya D Chakravarty; Xie L Xu; Ramanand A Subramanian; Prasheen Agarwal; Shihong Sheng; Yusang Jiang; Bei Zhou; Yanli Zhuang; Désirée van der Heijde; Philip J Mease Journal: Arthritis Rheumatol Date: 2021-03-17 Impact factor: 15.483
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