FRI0356 BURDEN OF DISEASE IN PATIENTS INITIATING APREMILAST TREATMENT: 2014-2019 FINDINGS FROM THE CORRONA PSORIATIC ARTHRITIS/SPONDYLOARTHRITIS REGISTRY
Authors: A. Ogdie, M. Liu, M. Glynn, K. Emeanuru, L. Harrold, J. Mohawk, S. Richter, B. Guerette, P. J. Mease
Journal: Annals of the Rheumatic Diseases (2020)

Background: The prospective, US-based, observational Corrona PsA/SpA Registry collects real-world data on patients (pts) with PsA provided by pts and their providers. Objectives: To examine trends in characteristics of pts initiating apremilast (APR) from 2014-2019 and compare characteristics of treatment-naive pts initiating APR or methotrexate (MTX). Methods: PsA pts aged ≥18 yrs enrolled in the registry who initiated APR, MTX, and/or biologics for PsA from January 2014-August 2019 were included and stratified by year of initiation (2014-2015, 2016-2017, or 2018-2019). Demographics, clinical characteristics, treatment history, disease activity, and pt-reported outcomes (PROs) were analyzed at treatment initiation. Comparisons between treatment-naive APR vs MTX initiators during the entire 2014-2019 study period were summarized descriptively. Results: 1460 PsA pts initiated APR (n=238), MTX (n=178), and/or a biologic (n=1044), including treatment-naive APR (n=20) and MTX (n=99) initiators from 2014-2019. For APR initiators in the 3 successive time periods, respectively, mean disease duration was 10.5, 12.2, and 11.4 yrs, and 87.5%, 82.5%, and 68.6% of pts had prior use of csDMARDs (similar to biologic initiators: 77.9%, 77.2%, and 68.8%). Over time, lower joint, enthesitis, and dactylitis counts, composite disease activity, and PRO measures of disease burden were observed (Table). Compared with treatment-naive MTX initiators, treatment-naive APR initiators had longer duration of PsA (8.5 vs 5.5 yrs) and time since PsA diagnosis (3.3 vs 1.8 yrs). Rates of comorbidities such as hypertension (50.0% vs 37.8%), diabetes mellitus (38.9% vs 13.3%), and metabolic syndrome (33.3% vs 8.9%) were higher in treatment-naive APR vs MTX initiators. Greater proportions of treatment-naive APR initiators had high/very high disease activity according to CDAI, DAPSA, cDAPSA, PASDAS, and DAS-28 vs MTX initiators. Conclusion: In this Corrona Registry analysis, PsA pts initiating APR had lower disease burden in recent vs prior yrs, indicating use of APR earlier in the course of PsA is increasing in real-world practice. Treatment-naive APR initiators had greater disease activity and severity vs MTX initiators. Comorbidities were common at APR initiation. Table: Disease Severity and Activity, and PROs for APR Initiators in the Corrona PsA/SpA Registry Characteristic 2014-2015 n=72 2016-2017 n=80 2018-2019 n=86 SJC (0-66), median (IQR) 2.0 (4.0) 1.0 (3.0) 0.0 (3.0) TJC (0-68), median (IQR) 5.0 (14.0) 2.0 (4.0) 2.0 (10.0) SPARCC enthesitis*, mean (SD) 4.7 (3.0) 3.8 (2.2) 3.7 (3.1) Dactylitis count † , mean (SD) 2.5 (2.5) 2.3 (1.0) 2.2 (2.3) cDAPSA category, n (%) Remission 4 (7.4) 8 (14.8) 13 (15.9) Low disease activity 12 (22.2) 18 (33.3) 30 (36.6) Minimal disease activity, n (%) 8 (15.1) 14 (26.9) 21 (25.6) DAS-28 remission, n (%) 5 (19.2) 8 (32.0) 24 (43.6) Pain VAS (0-100 mm) &gt;15, n (%) 47 (85.5) 47 (83.9) 60 (73.2) Pt’s Global Assessment of Arthritis VAS (0-100 mm) &gt;20, n (%) 47 (82.5) 45 (77.6) 54 (65.9) HAQ &gt;0.5, n (%) 39 (69.6) 35 (59.3) 44 (53.7) Fatigue VAS (0-100 mm), mean (SD) 56.7 (25.4) 49.8 (25.9 45.6 (31.5) Spine pain VAS (0-100 mm), mean (SD) 38.8 (27.6) 36.5 (29.6) 28.8 (34.1) BASDAI ‡ , mean (SD) 5.4 (2.4) 4.9 (2.5) 4.4 (2.6) Morning stiffness VAS (0-100 mm), mean (SD) 52.8 (27.3) 51.4 (28.3) 48.0 (31.2) The n represents the total sample. Number of pts with data available may vary. *Among pts with enthesitis at baseline. †Among pts with dactylitis at baseline. ‡Among pts thought to have spondylitis by the investigator. IQR=interquartile range. Disclosure of Interests: Alexis Ogdie Grant/research support from: Novartis, Pfizer – grant/research support, Consultant of: AbbVie, BMS, Eli Lilly, Novartis, Pfizer, Takeda – consultant, Mei Liu Shareholder of: Corrona, LLC – shareholder at the time of study conduct, Employee of: Corrona, LLC – employment at the time of study conduct, Meghan Glynn Shareholder of: Corrona, LLC – shareholder, Grant/research support from: Pfizer – grant/research support, Employee of: Corrona, LLC – employment, Kelechi Emeanuru Employee of: Corrona, LLC – employment, Leslie Harrold Shareholder of: Corrona, LLC – shareholder, Grant/research support from: Pfizer – grant/research support, Consultant of: AbbVie, BMS, Roche – consultant, Employee of: Corrona, LLC – employment, Jennifer Mohawk Employee of: Amgen Inc. – employment; Celgene Corporation – employment at the time of study conduct, Sven Richter Employee of: Amgen Inc. – employment; Celgene Corporation – employment at the time of study conduct, Benoit Guerette Employee of: Amgen Inc. – employment; Celgene Corporation – employment at the time of study conduct, Philip J Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – grant/research support, Consultant of: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – consultant, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB – speakers bureau