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OP0143 IMPACT OF ADALIMUMAB VERSUS NON-BIOLOGIC THERAPY ON DISEASE ACTIVITY AND PATIENT-REPORTED OUTCOMES IN ANKYLOSING SPONDYLITIS OVER 24 MONTHS – RESULTS OF THE COMPLETE-AS CANADIAN OBSERVATIONAL STUDY
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  1. L. Bessette1,
  2. A. Chow2,
  3. V. Pavlova3,
  4. M. C. Laliberté4,
  5. M. Khraishi5
  1. 1Laval University, Centre Hospitalier de l’Université Laval, Laval University, Centre Hospitalier de l’Université Laval, Quebec City, Canada
  2. 2University of Toronto, University of Toronto, Toronto, Canada
  3. 3McMaster University, McMaster University, Hamilton, Canada
  4. 4AbbVie Corporation, AbbVie Corporation, Montreal, Canada
  5. 5Memorial University of Newfoundland, Memorial University of Newfoundland, St. John’s, Canada

Abstract

Background: COMPLETE-AS was an observational study among Canadian biologic-naïve adults with active ankylosing spondylitis (AS) treated with either adalimumab or subsequent non-biologic disease-modifying anti-rheumatic drugs and/or non-steroidal anti-inflammatory drugs (nbDMARD/NSAID) after having switched from initial treatment with a preceding nbDMARD and/or NSAID due to lack of response or intolerance, as per treating physician judgement.

Objectives: To assess the impact of adalimumab on disease activity and patient-reported outcomes among adalimumab- vs. nbDMARD/NSAID-treated patients over 24 months.

Methods: Patients were enrolled between July 2011 and December 2017 and followed for up to 24 months. Treatment was per routine care and all analyses were perfomed using the intent-to-treat (ITT) approach. Between-group differences for change in patient-reported disease activity (BASDAI), morning stiffness (minutes/day), functional limitation (BASFI), quality of life (QoL: SF-12), depression (BDI-II), and work productivity (WLQ) were assessed with repeated measures models for overall treatment effect; baseline-adjusted estimates (least square means [LSM]) for each visit were produced. Achievement of, and time to the following endpoints were assessed: 50% improvement from baseline in BASDAI (BASDAI50); minimum clinically important improvements (MCIIs) in BASDAI (Δ≥1.1); BASFI (Δ≥0.6); SF-12 physical component score (PCS; Δ≥4.4) and mental component score (MCS; Δ≥3.1); and low disease activity for BASDAI (<4) and BASFI (<3.8).

Results: A total of 452 adalimumab-treated patients and 187 nbDMARD/NSAID-treated patients were enrolled in the study and included in the analyses. At baseline, mean (SD) BASDAI [6.4 (1.8) vs. 5.0 (1.8); p<0.001] and BASFI [5.5 (2.4) vs. 3.7 (2.4)] were however significantly (p<0.001) higher among adalimumab-treated patients compared to nbDMARD/NSAID-treated patients, respectively.

Over 24 months, adalimumab-treated patients had significantly lower overall BASDAI scores compared to nbDMARD/NSAID-treated patients [estimate (95% CI): -0.7 (-1.2, -0.3); p=0.007]. BASFI scores were also significantly lower among adalimumab-treated patients over the course of the study [estimate (95% CI): -0.4 (-0.8, 0.0); p=0.013]. Both groups had statistically comparable outcomes for morning stiffness, BDI-II, WLQ, and SF-12.

Adalimumab-treated patients were also at significantly higher odds of achieving therapeutic response thresholds, including BASDAI50 [OR (95% CI): 1.7 (1.2-2.3)], BASDAI<4 [1.8 (1.2-2.7)], MCII for BASDAI [1.9 (13.-2.9)], and MCII for BASFI [1.6 (1.1-1.2)]. Time to achievement of each threshold was significantly shorter among adalimumab-treated patients for BASDAI50 [HR (95% CI): 1.8 (1.1-2.8)], BASDAI<4 [1.7 (1.6-3.6)], and MCII for BASDAI [1.5 (1.0-2.3)]. Time to achievement of MCII for BASFI was not statistically different between groups; for BASFI<3.8 and MCII for both SF-12 PCS and MCS, both odds of, and time to achievement, were also statistically comparable.

At month 24, baseline-adjusted BASDAI and BASFI was comparable (p>0.05): LSM (95%CI) 3.5 (3.3, 3.8) vs. 3.6 (3.2-4.0), and 2.9 (2.6-3.1) vs. 3.3 (2.9-3.7), respectively, for adalimumab-treated vs. nbDMARD/NSAID-treated patients.

Conclusion: Among Canadian patients with active AS, adalimumab-treated patients reported a greater overall reduction in disease burden related to both self-reported disease activity and functional capacity compared to nbDMARD/NSAID-treated patients, along with higher odds and shorter time to achieving therapeutic response thresholds. Despite the overall beneficial effects observed with adalimumab, residual disease burden, however, is observed for Canadian AS patients even after 24 months of treatment.

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, Andrew Chow Speakers bureau: Speaker for AbbVie, BMS, Janssen, Pfizer, Consultant of: Consultant for AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Grant/research support from: Investigator for AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Viktoria Pavlova Speakers bureau: Speaker for Amgen, Abbvie, BMS, Jenssen, Lilly, Merk, Novartis, Roche, UCB, and Pfizer, Consultant of: Consultant for Amgen, Abbvie, BMS, Jenssen, Lilly, Merk, Novartis, Roche, UCB, and Pfizer, Grant/research support from: Investigator for Janssen, UCB, Abbvie, and Pfizer; and received research grants from UCB, 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

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