Reduced certolizumab pegol dose feasible for patients across axSpA spectrum
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Certolizumab pegol may be safely reduced in patients across the axial spondyloarthritis spectrum who have achieved sustained disease remission on a full dose of the drug, according to data presented at the EULAR 2020 E-Congress.
‘The abstract starts with asking the question what strategies for maintaining clinical remission are actually available for patients with axial spondyloarthritis that have been brought into remission with TNF blocking agents,” Robert B. M. Landewé, MD, PhD, professor in rheumatology at the Academic Medical Center/University of Amsterdam, and chair of the department of rheumatology at Zuyderland Medical Center Heerlen, in the Netherlands, said. “Previous studies have shown that if you withdraw TNF inhibitors in patients with sustained remission, especially those with ankylosing spondylitis, it will result in a flare.”
Landewe noted that no studies have formally examined TNF inhibitor dose reduction across the axSpA spectrum.
The aim of this study was to determine the proportion of patients who remained free of disease flare after withdrawal or dose reduction of certolizumab pegol (Cimzia, UCB). Eligible participants in the multicenter, two-part, phase 3b study had early axSpA disease, defined as less than 5 years of symptom duration. Patients were stratified by radiographic or non-radiographic subpopulation, sex and age.
During the induction period, after a loading dose of 400 mg on weeks 0, 2 and 4, patients were treated with 200 mg twice a week. At 48 weeks, patients in sustained remission — defined as Ankylosing Spondylitis Disease Activity Score less than 1.3 at 32 or 36 weeks and at 48 weeks; or at less than 1.3 at 32 weeks, less than 2.1 at 36 weeks, or vice versa, and then less than 1.3 at 48 weeks — were randomly assigned treatment for the maintenance part of the study.
For maintenance, patients received certolizumab pegol 200 mg every 2 weeks — which the researchers defined as the full maintenance dose — every 4 weeks (reduced maintenance dose) or placebo for another 48 weeks.
The primary endpoint for the maintenance part was ASDAS 2.1 or greater at two consecutive visits or more than 3.5 at any time point between weeks 48 and 96.
Results showed that 43.9% of 736 patients achieved sustained remission after the induction period, with 313 patients entering the maintenance leg.
Background data for these 313 patients showed that 168 had radiographic disease while 145 had nonradiographic disease. There were 247 men and 66 women, with 165 patients aged 32 years or younger and 145 aged older than 32 years.
Outcomes from the maintenance period showed that 83.9% of radiographic and 83.3% of nonradiographic patients receiving the full maintenance dose did not experience a flare. Among patients treated with the reduced maintenance dose, 82.1% of patients in the radiographic group and 75.5% of patients in the nonradiographic group were free of flare. By comparison, 17.9% of radiographic patients and 22.9% of nonradiographic patients in the placebo group experienced no flares.
Stratification by sex or age had no impact on response rates of certolizumab pegol dose, according to the results. “It was exactly the same picture,” Landewe said. “Half-dose certolizumab, after a 48-week induction period, was as good as full-dose, and far better than placebo.”
The trend was consistent among patients with radiographic and nonradiographic disease. “Half-dose is enough to maintain the state of remission,” Landewe said.
The researchers concluded that certolizumab pegol may be reduced in patients who have achieved sustained remission on a full induction dose of the drug. “This is the first study in an axSpA population, in a broad sense, to show this phenomenon,” Landewe said
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Landewe RBM, et al. OP0103. Presented at: EULAR 2020 E-Congress; June 3-6, 2020 (virtual meeting).
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