Discontinuation of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) after response to combination csDMARDs and certolizumab pegol therapy did not alter treatment effectiveness in patients with rheumatoid arthritis (RA), according to study findings published in Rheumatology.
The randomized, open-label study included 125 patients with RA treated with csDMARD(s) plus certolizumab pegol, 88 of whom were randomly assigned to either discontinue csDMARD therapy (n=45) or to remain on combination therapy (n=43) after 3 or 6 months of combined treatment. Only patients with a change of ≥1.2 in the 28-joint disease activity score (DAS28) were included. The primary endpoint was reaching low disease activity on DAS28 at 18 months, or noninferiority of continuing or discontinuing csDMARD(s) therapy on maintaining a change in DAS28 score of ≥1.2.
At 18 months, the researchers found that the noninferiority criteria was not met (absolute risk difference, 2.6%; upper limit of 90% CI, 19.1%), despite the rate of change in DAS28 score and/or achieving low disease activity on DAS28 being similar between the treatment arms (72% vs 69%).
“Safety and tolerability were comparable in RA patients withdrawing vs continuing csDMARD(s) after response to certolizumab pegol,” they reported.
One key limitation was the potential for assessment bias because of the open-label study design.
“Stopping csDMARDs after a treatment response with certolizumab pegol may be a successful strategy if required,” they concluded.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Pope J, Rampakakis E, Vaillancourt J, Bessette L, Lazovskis J, Haraoui B, Sampalis JS. An open-label randomized controlled trial of DMARD withdrawal in RA patients achieving therapeutic response with certolizumab pegol combined with DMARDs [published online October 18, 2019]. Rheumatology. doi:10.1093/rheumatology/kez470