Certolizumab efficacy for axial spondyloarthritis sustained over 4 years
medwireNews: The benefits of certolizumab pegol treatment in patients with axial spondyloarthritis are maintained over 4 years without worsening tolerability, researchers report.
They stress that the response to certolizumab, an anti-tumor necrosis factor (TNF) drug, was sustained to a similar degree in both patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis and included improvements in disease activity, function, spinal mobility, articular inflammation, enthesitis, and uveitis.
The phase III trial – RAPID-axSpA – involved 325 patients, of whom 218 were randomly assigned to receive certolizumab pegol at doses of 200 mg every 2 weeks or 400 mg every 4 weeks, and 107 to receive placebo.
The researchers note that patients originally assigned to placebo were switched to certolizumab at week 16 if they failed to meet a 20% improvement according to Assessment in Ankylosing Spondylitis Response Criteria (ASAS20), or at week 24. This meant that a total of 315 patients received certolizumab at any time during the study.
At week 204, 83.7% of the 135 patients who received certolizumab for the duration of the study met the criteria for an ASAS20 response. The percentage when non-responder imputation was used for missing data values or because of early patient withdrawal was 54.1%. The respective rates for meeting the criteria for an ASAS40 response were 68.1% and 44.0%.
Désirée van der Heijde (Leiden University Medical Center, the Netherlands) and colleagues point out that 76 patients withdrew from the study early, and only nine of these due to a lack of efficacy.
“The distribution of disease activity, at the point of withdrawal, in those patients who withdrew for reasons other than lack of efficacy, was comparable to disease activity at week 204 in patients who completed the study, which strengthens the conclusion that few patients withdrew because of lack of efficacy,” they note in Rheumatology.
Continuous measures of disease activity – Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) – confirmed that response to certolizumab was maintained relatively consistently between weeks 24 and 204 and to a similar degree in both patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis.
There was also no significant effect of age, gender, concomitant or prior use of disease-modifying anti-rheumatic drugs, symptom duration or prior anti-TNF exposure on response.
Improvements in patient-reported outcomes, including back pain, morning stiffness, fatigue, sleep, and overall health-related quality of life, at week 24 were sustained to week 204. And improvements in swollen and tender joint counts, enthesitis and uveitis were sustained or further improved between week 24 and 204.
In accordance with treat-to-target guidelines for spondyloarthritides, remission, defined as ASDAS-inactive disease or a BASDAI score below 2 with normal C-reactive protein levels, was achieved by 30.3% of certolizumab-treated patients at week 24 on both measures and by 32.1% and 33.0%, respectively, at week 204.
This was achieved without any new safety signals reported between weeks 96 and 204 and no deaths over the whole 4 years. Over a total certolizumab exposure of 981 person–years, the adverse event rate was 292.8 per 100 person–years, of which just 10.4 were serious.
By Lucy Piper
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