POS0232 CLINICAL EFFECTIVENESS OF ADALIMUMAB VERSUS NON-BIOLOGIC THERAPY IN THE MANAGEMENT OF EXTRA-ARTICULAR MANIFESTATIONS IN ANKYLOSING SPONDYLITIS PATIENTS OVER 24 MONTHS – RESULTS OF THE COMPLETE-AS CANADIAN OBSERVATIONAL STUDY
Authors: L. Bessette, B. Haraoui, B. Florica, M. C. Laliberté, M. Khraishi
Journal: Annals of the Rheumatic Diseases (2021)

Background: COMPLETE-AS was a Canadian observational study among biologic-naïve adults with active ankylosing spondylitis (AS) initiated on either adalimumab (ADA) or subsequent non-biologic disease-modifying anti-rheumatic drugs and/or non-steroidal anti-inflammatory drugs (nbDMARD/NSAID) after a switch from initial treatment due to inadequate response or intolerance, as per the judgement of the treating physician. Objectives: The aim of this analysis was to assess the 24-month effectiveness of ADA compared to nbDMARD/NSAID in the management of heel enthesitis and extra-articular manifestations (EAMs). Methods: Patients were enrolled between July 2011 and December 2017, and followed for up to 24 months. Patients were treated as per routine care and all analyses were performed using the intent-to-treat (ITT) approach. The disease outcomes assessed in this study included enthesitis (of the heel) and EAMs [inflammatory bowel disease (IBD), uveitis, and psoriasis (PsO)]. The rate ratio (RR) for first occurrence or flare-up/exacerbation of disease outcomes was ascertained with multivariate models. The time to first occurrence of EAMs and enthesitis was ascertained with Cox proportional hazard models, generating a hazard ratio (HR). Results: A total of 452 patients treated with ADA and 187 patients receiving a subsequent nbDMARD/NSAID were enrolled in the study. Baseline characteristics were overall comparable between treatment groups: patients had a mean (SD) age of 42.7 (13.4) years, 55.6% were male, and 85.8% were Caucasian. The mean (SD) duration of AS since diagnosis was 5.6 (9.3) years. A total of 17.7%, 12.4%, 18.5%, and 16.3% of patients had experienced enthesitis, IBD, uveitis, and PsO, respectively at baseline. Disease severity (mean [SD] BASDAI) was however higher among ADA- vs. nbDMARD/NSAID-treated patients (6.4 [1.8] vs. 5.0 [1.8]; p&lt;0.001). In terms of the rates of first occurrence or flare-up/exacerbation of enthesitis and EAMs, statistically significant between-group differences were found, whereby ADA-treated patients had a 60% reduced rate of both uveitis [RR (95% CI): 0.4 (0.2-0.6)] and enthesitis [0.4 (0.3-0.7)] compared to nbDMARD/NSAID-treated patients. The rates of first occurrence or flare-up/exacerbation for IBD [1.1 (0.7-1.7)] and PsO [3.3 (0.9-12.7)]were statistically comparable between treatment groups. The time to first occurrence of both enthesitis and uveitis was also statistically significant (p&lt;0.05) between groups. ADA-treated patients had a 50% lower risk of enthesitis as a first occurrence compared to nbDMARD/NSAID-treated patients [HR (95% CI): 0.5 (0.3-0.9)], and an 80% lower risk of uveitis [0.2 (0.0-0.8)]. The time to first occurrence of IBD [0.7 (0.2-2.1)] and PsO [1.9 (0.8-4.6)], were statistically comparable between treatment groups. Conclusion: Despite a comparable proportion of patients reporting baseline EAMs and enthesitis, patients treated with ADA were less likely to experience a first occurrence or flare-up/exacerbation, of both enthesitis and uveitis compared to patients treated with nbDMARD/NSAID. The results of this real-world Canadian study suggest that treatment with ADA among AS patients is more effective at preventing the first occurrence / exacerbation of select EAMs and heel enthesitis. Acknowledgements: The authors wish to acknowledge JSS Medical Research for their contribution to the statistical analysis, medical writing, and editorial support during the preparation of this abstract. AbbVie provided funding to JSS Medical Research for this work. Disclosure of Interests: Louis Bessette Speakers bureau: Speaker for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Lilly, Novartis, Gilead, Sandoz, Fresenius Kabi, Consultant of: Consultant for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Celgene, Lilly, Novartis, Gilead, Sandoz, Samsung Bioepis, Fresenius Kabi, Grant/research support from: Investigator for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Gilead, Boulos Haraoui Speakers bureau: Speakers for AbbVie, Amgen, BMS, Gilead, Lilly, Merck, Pfizer, Sandoz, and UCB, Consultant of: Advisor for AbbVie, Amgen, BMS, Gilead, Lilly, Merck, Pfizer, Sandoz, and UCB, Grant/research support from: Research grants from AbbVie, Amgen, BMS, Gilead, Lilly, Merck, Pfizer, Sandoz, and UCB, Brandusa Florica Speakers bureau: Speaker for Merck, AbbVie, Roche, BMS, and Novartis, Consultant of: Consultant for Roche, AbbVie, Pfizer, Janssen, Celgene, and UCB, Grant/research support from: Investigator for AbbVie, Pfizer, and BMS, Marie-Claude Laliberté Employee of: Employee of AbbVie, Majed Khraishi Speakers bureau: Speaker for AbbVie, Consultant of: Consultant for AbbVie, Grant/research support from: Principal Investigator for AbbVie.