Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: results of a randomised placebo-controlled trial (ABILITY-1)

Abstract

PurposeTo evaluate the efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis (nr-axSpA).MethodsPatients fulfilled Assessment of Spondyloarthritis international Society (ASAS) criteria for axial spondyloarthritis, had a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥ 4, total back pain score of ≥ 4 (10 cm visual analogue scale) and inadequate response, intolerance or contraindication to non-steroidal anti-inflammatory drugs (NSAIDs); patients fulfilling modified New York criteria for ankylosing spondylitis were excluded. Patients were randomised to adalimumab (N=91) or placebo (N=94). The primary endpoint was the percentage of patients achieving ASAS40 at week 12. Efficacy assessments included BASDAI and Ankylosing Spondylitis Disease Activity Score (ASDAS). MRI was performed at baseline and week 12 and scored using the Spondyloarthritis Research Consortium of Canada (SPARCC) index.ResultsSignificantly more patients in the adalimumab group achieved ASAS40 at week 12 compared with patients in the placebo group (36% vs 15%, p<0.001). Significant clinical improvements based on other ASAS responses, ASDAS and BASDAI were also detected at week 12 with adalimumab treatment, as were improvements in quality of life measures. Inflammation in the spine and sacroiliac joints on MRI significantly decreased after 12 weeks of adalimumab treatment. Shorter disease duration, younger age, elevated baseline C-reactive protein or higher SPARCC MRI sacroiliac joint scores were associated with better week 12 responses to adalimumab. The safety profile was consistent with what is known for adalimumab in ankylosing spondylitis and other diseases.ConclusionsIn patients with nr-axSpA, adalimumab treatment resulted in effective control of disease activity, decreased inflammation and improved quality of life compared with placebo. Results from ABILITY-1 suggest that adalimumab has a positive benefit–risk profile in active nr-axSpA patients with inadequate response to NSAIDs.

Symptomatic Efficacy of Etanercept and Its Effects on Objective Signs of Inflammation in Early Nonradiographic Axial Spondyloarthritis: A Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Trial

“…In the Ability-1 study (18), the treatment effect of adalimumab, assessed using the end point ASAS40, was similar to that observed with etanercept after 12 weeks of treatment in the present study (38). When comparing the present study with the RAPID-axial SpA trial of certolizumab pegol treatment (20), several important differences in patient inclusion criteria and baseline demographic and disease characteristics are evident.…”

“…Recently, several studies of anti-TNF therapy have been conducted in nonradiographic axial SpA, with results suggesting that these agents have efficacy similar to that seen in radiographic axial SpA (15)(16)(17)(18)(19)(20). However, to date the number of large well-controlled studies of treatment with anti-TNF or other biologic agents in nonradiographic axial SpA, including populations of patients satisfying current ASAS criteria for nonradiographic axial SpA, is limited.…”

A Randomized, Double‐Blind, Placebo‐Controlled Multicenter Study of Adalimumab in Pediatric Patients With Enthesitis‐Related Arthritis

“…Safety results were similar to those obtained in adalimumab trials of polyarticular JIA 23, 24, 25 and adults with rheumatoid arthritis and SpA 26, 27, 39. No AEs were identified that were unique to patients with ERA.…”

“…Adalimumab has been previously demonstrated to be safe and effective in children ages 2–17 years with polyarticular JIA 23, 24, 25, in children ages 12–17 years with refractory juvenile ankylosing spondylitis having axial symptoms 19, and in adults with axial SpA 26, 27.…”

Brief Report: Six‐Week Treatment of Axial Spondyloarthritis Patients With an Optimal Dose of Nonsteroidal Antiinflammatory Drugs: Early Response to Treatment in Signal Intensity on Magnetic Resonance Imaging of the Sacroiliac Joints

“…In a randomized controlled trial of adalimumab in 82 predominantly male AS patients, a significant decrease of 52.9% (9.3 units) in SPARCC scores of the SI joints was observed in adalimumab-treated patients after 12 weeks of therapy, whereas a decrease of only 12.7% (1.3 units) was observed in placebo-treated patients (15). In the Ability-1 Trial of adalimumab in nonradiographic axial SpA, a mean decrease of 62.7% (3.2 units) in SPARCC score for the SI joint was reported, while the placebo responses showed a decrease of 12.8% (0.6 units) (16). However, the participants in those studies were older, had a longer disease duration, and had substantially lower mean baseline SPARCC scores than the patients in the present study.…”