Reduced maintenance dose of certolizumab pegol can be used in axSpA

Outcomes of the C-OPTIMISE trial show 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 flares [1,2].

Prof. Robert Landewé (University of Amsterdam, the Netherlands) presented the multicentre, 2-part, phase 3b C-OPTIMISE trial. Aim of the study was to determine the number of patients who remained free of disease flare after withdrawal or dose reduction of certolizumab pegol, by analysing whether responses to reduced maintenance dose were comparable in patients stratified by subpopulation, gender, and age. Eligible participants were patients with early axSpA, defined as <5 years symptom duration. 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 (i.e. Ankylosing Spondylitis Disease Activity Score [ASDAS] <1.3 at week 32 or 36 [if ASDAS was <1.3 at week 32, it must be <2.1 at week 36, or vice versa] and at week 48) were randomised 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 the maintenance period of 48 weeks. The primary endpoint was the percentage of patients not experiencing a flare (ASDAS ≥2.1 at 2 consecutive visits or >3.5 at any timepoint) between week 48 and 96.

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 maintenance 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 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. Similar responses were seen when stratified by sex or age. Prof. Landewé emphasised 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.

1. Landewé RBM, et al. OP0103. EULAR E-Congress, 3-6 June 2020.
2. Landewé RBM, et al. Ann Rheum Dis. 2020;annrheumdis-2019-216839.

 



Posted on 14 August, 202025 March, 2024