Certolizumab pegol dose reduction feasible in axSpA remission
medwireNews: Patients with early axial spondyloarthritis (axSpA) who achieve remission with certolizumab pegol can reduce their dose without increasing their risk for flares but should not stop treatment completely, show results of the phase 3b C-OPTIMISE trial.
Robert Landewé (Amsterdam Rheumatology Center, the Netherlands) and co-investigators say their findings are “important […] for clinicians who face decisions on how best to manage axSpA patients in sustained remission.”
The two-part study included a 48-week open-label induction period, in which 736 patients (mean age 33 years, 70% men) with early active axSpA (mean symptom duration 3.3 years) received the tumor necrosis factor (TNF) inhibitor certolizumab pegol 200 mg every 2 weeks. Just over half (55%) of participants had ankylosing spondylitis (radiographic axSpA) and the remainder had nonradiographic axSpA.
At week 48, 323 (43.9%) patients were in sustained remission (ASDAS <1.3 points at week 32 or 36 and at week 48).
Of these, 313 (96.9%) were included in the maintenance period of the study and were randomly assigned to receive certolizumab pegol 200 mg every 2 weeks (full maintenance dose; n=104), certolizumab pegol 200 mg every 4 weeks (reduced maintenance dose; n=105), or placebo (withdrawal; n=104) for a further 48 weeks.
The researchers report in the Annals of the Rheumatic Diseases that the proportion of patients who remained flare-free at week 96 was significantly higher with the full and reduced maintenance doses than with placebo, at 83.7% and 79.0% versus 20.2%, respectively. A flare was defined as an ASDAS of 2.1 points or higher at two consecutive visits or above 3.5 points at any time.
And the team notes that the response rates were similar regardless of whether participants had radiographic or nonradiographic axSpA.
Among the patients who experienced flares and thus restarted certolizumab pegol 200 mg every 2 weeks, 16.7% of six from the full maintenance group, 60.0% of 15 from the reduced maintenance group, and 63.4% of 71 from the placebo group regained clinical remission within 12 weeks. The corresponding rates of ASDAS low disease activity (<2.1 points) were 66.7%, 80.0%, and 90.1%.
The team also found that individuals who received the full or reduced certolizumab pegol maintenance dose had stable disease activity according to BASDAI, stable function as measured by BASFI, and stable mobility according to BASMI between weeks 48 and 96.
By contrast, individuals in the placebo arm experienced worsening disease activity and function during the maintenance period.
Landewé et al conclude: “[Certolizumab pegol] maintenance dose reduction is a feasible option for the long-term management of patients with axSpA in remission, preserving the clinical benefits of remaining on TNF [inhibitor] treatment, reducing costs and limiting patients’ long-term exposure to immunosuppressive therapy.”
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