Outcomes of the C-OPTIMISE trial showed that a reduced maintenance dose of certolizumab pegol may be used in patients with axial spondyloarthritis (axSpA) who have been treated with the drug for a year and who have achieved sustained disease remission, regardless of subpopulation. However, complete treatment withdrawal is not recommended due to the high risk of flare [1,2].
Researchers aimed to determine the number of patients who remained free of disease flare after withdrawal or dose reduction of certolizumab pegol, by analyzing whether responses to reduced maintenance dose were comparable in patients stratified by subpopulation, gender, and age.
C-OPTIMISE was a multicentre, two-part, phase 3b trial, for which patients with early axSpA (which was defined as <5 years symptom duration) were eligible. Patients were treated with certolizumab pegol 200 mg every 2 weeks with a loading dose of 400 mg at weeks 0, 2, and 4 during the open-label induction period. At week 48, patients in sustained remission (ASDAS <1.3 at week 32 or 36 [if ASDAS <1.3 at week 32, it must be <2.1 at week 36, or vice versa] and at week 48) were randomized to double-blind full maintenance dose of certolizumab pegol 200 mg every 2 weeks; reduced maintenance dose (200 mg every 4 weeks); or placebo for a further 48 weeks. The primary endpoint for the maintenance period was remaining free of flares (with flare defined as ASDAS ≥2.1 at two consecutive visits or ≥3.5 at any timepoint between week 48 and 96).
It was shown that during the 48-week induction period, 43.9% of patients (n=323) achieved sustained remission and 313 patients entered the 48-week maintenance period. During this period, responses in radiographic and non-radiographic axSpA patients were comparable across all 3 randomised arms. In total, 83.9% of radiographic axSpA patients and 83.3% of non-radiographic axSpA patients who received the full maintenance dose of certolizumab pegol did not experience a flare. This was also the case in the reduced maintenance dose arm for 82.1% and 75.5%, respectively. Rates for the placebo group were 17.9% and 22.9%, respectively. When stratified by sex or age, similar responses were seen.
It was emphasized by Prof. Landewé that half-dose certolizumab pegol administered after a 48-week induction period is just as beneficial as the full dose, and far better than placebo.
Reference:
1. Landewé RBM, et al. Does gender, age or subpopulation influence the maintenance of clinical remission in axial spondyloarthritis following certolizumab pegol dose reduction? OP0103. EULAR 2020.
2. Landewé RBM, et al. Maintenance of Clinical Remission in Early Axial Spondyloarthritis Following Certolizumab Pegol Dose Reduction Ann Rheum Dis. 2020;annrheumdis-2019-216839.