1 Khraishi et al Canadian Adalimumab Postmarketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis (COMPLETE-PsA): 12-month Results of Comparative Effectiveness of Adalimumab and nbDMARDs Majed M. Khraishi 1 , Valencia P. Remple 2 , Samuel Silverberg 3 , Jacqueline C. Stewart 4 , Brandusa Florica 5 , and Louis Bessette 6 ABSTRACT. Objective. COMPLETE-PsA was an observational study of biologic-naïve Canadian adults with active pso- riatic arthritis (PsA) treated with adalimumab (ADA) or a nonbiologic disease-modifying antirheumatic drug (nbDMARD) regimen, afer inadequate response/intolerance to a current nbDMARD treatment regimen. Te aim of this analysis was to assess the 12-month efectiveness of ADA vs nbDMARDs. Methods. Patients enrolled between March 2012 and November 2017 were included. Te following clin- ical variables and patient-reported outcomes were collected/calculated per routine care: Disease Activity Index for Psoriatic Arthritis in 28 joints (DAPSA28), Disease Activity Score in 28 joints (DAS28), erythro- cyte sedimentation rate (ESR), C-reactive protein, physician global assessment (PGA), patient global assess- ment (PtGA), pain, Health Assessment Questionnaire–Disability Index (HAQ-DI), 12-item Short Form Health Survey, enthesitis, dactylitis, body surface area (BSA), and time to achieving American College of Rheumatology (ACR) 50, ACR70, and modifed minimal disease activity (mMDA). Results. Two hundred and seventy-seven ADA-treated and 148 nbDMARD-treated patients were included. At baseline, ADA-treated patients were less likely to be employed, had longer morning stifness, higher DAPSA28, DAS28, PGA, PtGA, pain, and HAQ-DI, and lower prevalence of dactylitis (all P < 0.05). ADA-treated patients showed lower baseline-adjusted DAPSA28 (16.5 vs 26.6), DAS28 (2.8 vs 3.9), PGA (25.3 vs 37.1), and ESR (10.4 vs 15.0 mm/h) afer 3 months compared to nbDMARD-treated patients, with observed improvements maintained to month 12. Time to achievement of ACR50, ACR70, and mMDA was signifcantly shorter (P < 0.001) among ADA-treated patients, with the likelihood of having dactylitis (odds ratio [OR] 0.4, 95% CI 0.2–0.6) and BSA< 3% (OR 2.7, 95% CI 1.5–5.0) signifcantly lower and higher, respectively. Switching to another biologic was less likely in ADA-treated vs nbDMARD-treated patients (hazard ratio 0.3, 95% CI 0.2–0.5). Conclusion. In a real-world Canadian population of patients with PsA, ADA was more efective than nbDMARDs at reducing disease activity and the severity of skin involvement, and demonstrated higher retention. [ClinicalTrials.gov: NCT01559038] Key Indexing Terms: disease-modifying antirheumatic drugs, longitudinal studies, nonsteroidal antiinfam- matory drugs, psoriatic arthritis The design, study conduct, and financial support for the study were provided by AbbVie. 1 M.M. Khraishi, MB BCh, FRCP(C), Memorial University of Newfoundland, St. John’s, Newfoundland and Labrador, Canada; 2 V.P. Remple, MSN, PhD, AbbVie Biopharmaceuticals Sarl, Rungis, France; 3 S. Silverberg, MD, Etobicoke General Hospital, Toronto, Ontario, Canada; 4 J.C. Stewart, MD, FRCPC, University of British Columbia, Penticton, British Columbia, Canada; 5 B. Florica, MD, PhD, FRCPC, University of Toronto, Toronto, Ontario, Canada; 6 L. Bessette, MD, FRCPC, MSc, Laval University, Centre Hospitalier de l’Université Laval, Quebec City, Quebec, Canada. MMK is a speaker, consultant, and principal investigator for AbbVie. VPR receives a salary and stock options as an employee of AbbVie. SS is an advisory board consultant for AbbVie and a consultant for Janssen. JCS is an advisory board consultant for AbbVie, Amgen, Celgene, Merck, Novartis, Pfizer, Sanofi Genzyme, Celltrion, Roche, and Sandoz; a speaker for AbbVie, Amgen, Janssen, and Eli Lilly; and has participated in research with AbbVie, BMS, Janssen, and Roche. BF is a speaker for Merck, AbbVie, Roche, BMS, and Novartis; a consultant for Roche, AbbVie, Pfizer, Janssen, Celgene, and UCB; and an investigator for AbbVie, Pfizer, and BMS. LB is a speaker for Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Eli Lilly, and Novartis; a consultant for Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Celgene, Eli Lilly, and Novartis; and an investigator for Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Eli Lilly, and Novartis. Address correspondence to Dr. M.M. Khraishi, 220 Elizabeth Ave, St. John’s, NL A1C 5S7, Canada. Email: mkhraish@mun.ca. Accepted for publication December 24, 2021. Te Journal of Rheumatology 2022;xx:xxxx doi:10.3899/jrheum.200609 First Release February 15 2022 © 2022 Te Journal of Rheumatology. Tis is an Open Access article, which permits use, distribution, and reproduction, without modifcation, provided the original article is correctly cited and is not used for commercial purposes. www.jrheum.org Downloaded on April 14, 2022 from