Background ABILITY 1 demonstrated that adalimumab (ADA) is effective in reducing the signs and symptoms of non-radiographic axial spondyloarthritis (nr-axSpA) compared to placebo (PBO) at Week (Wk) 12.1
Objectives To describe the long-term efficacy and safety of ADA in patients (pts) with nr-axSpA.
Methods ABILITY 1 is an ongoing phase 3, multicenter, double-blind, randomized, controlled trial of ADA 40 mg every other week (eow) vs PBO in pts with nr-axSpA (fulfilling ASAS axial SpA criteria but not modified New York criteria for AS) who had an inadequate response, intolerance, or contraindication to NSAIDs. The 12-wk double blind period is followed by an open-label (OL) extension phase in which pts could receive OL ADA 40 mg eow for up to an additional 144 wks. This post hoc analysis evaluated data at Wk 68 of the study. The percentages of pts satisfying various clinical endpoints at Wk 68 were summarized by observed data analysis and by non-responder imputation (NRI). Safety was assessed in terms of adverse events.
Results Pts who entered the OL period (n=179; 87/91 and 92/94 from the original ADA and PBO arms, respectively) had baseline demographics and disease characteristics that were comparable with those of pts initially randomized (55% female, 98% white, 9.8 years of symptom duration, 49% had past or present MRI sacroiliitis, 79% were HLA-B27 positive, and the mean BASDAI was 6.5). The study met its primary endpoint – % Wk 12 ASAS40 responders, 36% ADA vs 15% PBO (P <0.001, NRI). A total of 144 pts completed Wk 68 of the study (69 from ADA, 75 from original PBO). PBO pts who switched to OL ADA had improved disease signs and symptoms to levels that were comparable with those of pts who received ADA throughout (Table). As of Wk 68 of the study and 193.3 pt years of ADA exposure, there were only 3 serious infections (1.6 events/100 pt-years), which included 1 case of TB. There was 1 death due to suicide. No malignancies, demyelinating diseases, or lupus-like syndromes have been reported.
Conclusions Among pts who remained on ADA therapy, further improvement was noted beyond Wk 12, with almost half achieving ASDAS inactive disease state at Wk 68. These long-term data demonstrate continued efficacy and support the use of ADA therapy for pts with nr-axSpA.
Sieper J, et al. Arthritis Rheum 2011;63(10 Supplement):S970-1.
Disclosure of Interest J. Sieper Grant/Research support from: Abbott, Merck, Pfizer, UCB, Consultant for: Abbott, Merck, Pfizer, UCB, Speakers Bureau: Abbott, Merck, Pfizer, UCB, D. van der Heijde Consultant for: Abbott, Amgen, AstraZeneca, BMS, Centocor, Chugai, Merck, Novartis, Otsuka, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB, Wyeth, M. Dougados Grant/Research support from: Abbott, Pfizer, Roche, UCB, BMS, Merck, Consultant for: Abbott, Pfizer, Roche, UCB, BMS, Merck, F. Van den Bosch Consultant for: Abbott, Merck, UCB, P. Goupille Consultant for: Abbott, BMS, Merck, Pfizer, Roche, Schering-Plough, UCB, Wyeth, S. Sarkar Shareholder of: Abbott, Employee of: Abbott, A. Pangan Shareholder of: Abbott, Employee of: Abbott
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