Background/Purpose:  COMPLETE-PsA is an ongoing observational study planning to enroll 670 psoriatic arthritis (PsA) patients (pts) from ~40 sites across Canada. Main objectives are to compare the real-life effectiveness of adalimumab (ADA) to traditional non-biologic DMARDs and to describe the PsA burden of illness. The goal of this analysis is to describe the demographics and baseline disease parameters of the cohort and to report preliminary Canadian data on the real-life effectiveness of ADA in PsA.

Methods:

This was a pre-specified interim analysis of pts enrolled between 8/2011−8/2015. Eligible pts are adults with active PsA with ≥3 tender and swollen joints, active psoriatic skin lesions or confirmed history of psoriasis, who are anti-TNF naïve and require a change in current treatment. Pts are followed for up to two years as per routine care with suggested assessments at months 3, 6, 9, 12, 18, and 24. Data captured include disease activity (28 tender [TJC28] and swollen [SJC28] joints, HAQ, physician [PGA] and patient [PtGA] global assessment, morning stiffness, psoriasis body surface area [BSA], PASQ, and DLQI), periarticular manifestations, quality of life (SF-36, BDI-II), and work limitations (WLQ).

Results:

Of the 319 pts (ADA n=181, DMARD n=138) included in the analysis, 236 (74%) had available 6-month data. At baseline, mean age was 51.0 yrs (SD 12.3), 51.7% were female, and mean disease duration was 4.2 yrs (SD 6.5). There were no significant differences between treatment groups. Family history of PsA (14.2%) and arthritis subtype (64.2% symmetric polyarthritis) were also comparable.

 Within the ADA group, 79.6% were treated with a concomitant DMARD (MTX: 65.7%; HCQ: 18.2%; SSZ: 16%; LEF: 9.4%; AZA: 1.7%; Gold: 1.1%) at baseline, while 63.5% had been previously treated with a DMARD (33.1% with 1 DMARD, 18.8% with 2, 11.6% with ≥3). Within the DMARD group, the following DMARDs were used: MTX (85% of pts), HCQ (18.0%), SSZ (18%), LEF (15.8%), and AZA (1.5%); with 33.8% using ≥1 DMARDs.

 At baseline, ADA pts had significantly higher DAS28 (4.9 vs. 4.5; P=0.017), SJC28 (8.5 vs. 6.0; P<0.001), morning stiffness (88.5 vs. 58.7 min; P=0.008), PtGA (56.6 vs. 44.6; P<0.001), HAQ (1.1 vs. 0.9; P<0.001), and lower SF-36 score (26.6 vs. 27.4; P=0.003) but statistically comparable CRP, ESR, TJC28, BSA, PGA, PASQ, and DLQI. Productivity loss was higher in the DMARD group (17.8% vs. 16.4%; P=0.021).

 By 6 months, 8% of pts in the DMARD group vs. 2.8% in the ADA group (P=0.035) were discontinued. At 6 months, significant improvements were observed in almost all disease parameters. Adjusting for baseline values, ADA pts had significantly lower DAS28 (2.6 vs. 3.7; P<0.001), TJC28 (3.0 vs. 5.8; P=0.001), SJC28 (1.4 vs. 4.2; P<0.001), PGA (16.9 vs. 34.5; P<0.001), PtGA (29.3 vs. 39.9; P=0.030), HAQ (0.64 vs. 0.93; P<0.001), PASQ (9.5 vs. 10.7; P=0.015) and DLQI (2.2 vs. 4.1; P=0.015) vs. pts in the DMARD group.

Conclusion:  PsA pts initiating ADA in Canadian routine clinical care have more severe disease compared with those initiating traditional DMARDs. However, over 6 months, ADA treatment had better retention, and was more effective in reducing symptom severity and improving outcomes.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/canadian-humira-post-marketing-observational-epidemiological-study-assessing-effectiveness-in-psoriatic-arthritis-complete-psa-interim-analysis/