Results from a randomized controlled trial published in Arthritis & Rheumatology support the efficacy of adding certolizumab pegol (CZP) to background medication as treatment for nonradiographic axial spondyloarthritis (axSpA).
As part of the ongoing C-axSpAnd Study (ClinicalTrials.gov identifier: NCT02552212), patients with nonradiographic axSpA were recruited from 80 centers in Australia, Europe, North America, and Taiwan and randomly assigned 1:1 to receive either CZP or placebo in addition to their current nonbiologic background medication (NBBM) for 52 weeks. Study treatment was administered by prefilled syringe; CZP was given at a dose of 400 mg at weeks 0, 2, and 4, followed by 200 mg every 2 weeks until study completion.
As the primary outcome measure, investigators captured the proportion of patients achieving major improvement by week 52, defined as a ≥2.0-point decrease in Ankylosing Spondylitis Disease Activity Scorefrom baseline. Achievement of 40% improvement according to the Assessment in SpondyloArthritis international Society 40 at weeks 12 and 52 was assessed as a secondary endpoint. Investigators also captured any switches to open-label treatment (CZP or other biologic) or changes in background medication.
A total of 317 patients were randomly assigned to receive placebo plus NBBM (n=158) or CZP plus NBBM (n=159). Demographic characteristics were similar across study groups, with the majority of participants residing in Europe (n=260). Half of all participants were women and mean (±SD) age was 37.4 ± 10.8 and 37.3 ± 10.5 for the placebo and CZP groups, respectively.
Major improvement according to the Ankylosing Spondylitis Disease Activity Score was achieved in 47.2% of patients receiving CZP, compared with just 7.0% of patients receiving placebo (P <.0001). By week 52, 60.8% of patients in the placebo plus NBBM group had switched to open-label treatment, compared with 12.6% of patients in the CZP group.
Additionally, 69.6% of patients treated with placebo had changes made to their background medications during the study, compared with 27.7% of patients in the CZP group. Compared with patients receiving placebo, a greater proportion of the CZP group achieved Assessment in SpondyloArthritis international Society40 at week 12 (47.8% vs 11.4%) and week 52 (56.6% vs 15.8%; both P <.0001).
These data suggest that adding CZP to background medication is superior to adding placebo in the treatment of nonradiographic axSpA. The low incidence of remission among placebo-treated patients also underscores the limitations of nonbiologic therapy in treating active disease; options beyond nonbiologics remain important in reducing symptoms.
Disclosure: UCB Pharma was involved in study conduct, data analysis, data interpretation and writing of the final report. Multiple authors disclosed affiliations with pharmaceutical companies. See the reference for complete disclosure information.
Deodhar A, Gensler LS, Kay J, et al. A fifty-two-week, randomized, placebo-controlled trial of certolizumab pegol in nonradiographic axial spondyloarthritis [published online March 8, 2019]. Arthritis Rheumatol. doi:10.1002/art.40866