The use of certolizumab pegol was proven effective in the treatment of non-radiographic axial spondyloarthritis (nr-axSpA), based on the findings of the Phase 3 C-AXSPAND study, published in Arthritis & Rheumatology.
CIMZIA (UCB Pharmaceuticals) is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA), adults with active psoriatic arthritis (PsA), adults with active ankylosing spondylitis (AS), and indicated for the treatment of moderate to severe plaque psoriasis. However, CIMZIA is not currently approved for the treatment of nr-axSpA by the U.S. Food and Drug Administration (FDA).
Certolizumab pegol significantly reduced disease activity and signs of inflammation compared with placebo among patients with non-radiographic axial #spondyloarthritis, according to 52-week data from the C-axSpAnd trial.#axSpA#AnkylosingSpondylitishttps://t.co/57yCOhhz7n
— Bhushan Ghate (@bhushanghate) November 18, 2018
An International, Multi-Center Study
In this 52-week, parallel-group, double-blind study to examine CIMZIA’s safety and efficacy in nr-axSpA, researchers enlisted 317 nr-axSpA patients with objective signs of inflammation from 80 centers across Australia, Europe, North America, and Taiwan. Patients were randomized (1:1) to receive either placebo (n=158) or CZP (n=159). The CZP group received 400 mg of the therapy at zero, two, and four weeks, followed by 200 mg every two weeks, in addition to the non-biologic background mediation (NBBM). Researchers authorized participants to switch to open-label CZP (or other biologic) at any point, however, changes prior to week 12 were discouraged. The study’s primary endpoint was proportion of patients attaining a significant improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS-MI: ≥2.0) point decrease from baseline or lowest possible score [0.6] at week 52.
Certolizumab pegol: results from the 52-week Phase 3 C-AXSPAND study in Non-Radiographic AxSpA.
Primary objective, with 47.2% of Certolizumab patients demonstrating major improvement in disease activity (ASDAS-MI) at Week 52 versus 7% of placebo patient.https://t.co/oCXZfFUU8b
— Nigil Haroon (@NigilHaroon) May 21, 2018
CIMZIA Passes on Efficacy
According to the study results, ASDAS-MI was achieved in 47.2% (75/159) CZP+NBBM patients, which was significantly greater when juxtaposed with the 7% (11/158) of placebo+NBBM patients who reached the same result. Moreover, 60.8% (96/158) of placebo+NBBM patients switched to open-label treatment prior week 52, compared to only 12.6% (20/159) in the CZP+NBBM group.
“People living with nr-axSpA experience a significant disease burden, as there are currently no treatment options approved for this patient population in the US,” said lead investigator Atul Deodhar, MD, a professor of medicine at Ohio State University, in a press release. “The results from the C-AXSPAND study are uniquely impactful as they show that nr-axSpA does not improve spontaneously and most patients do not typically experience relief with existing medications, such as NSAIDs or analgesics. These data will help inform and evolve the treatment landscape for nr-axSpA.”
The next steps of the C-AXSPAND study will consist of an additional two years of safety follow-up, which are underway.
“These findings are particularly revealing because they highlight the importance of disease control for patients living with non-radiographic axial spondylarthritis, for whom common medications may not adequately control active disease,” stated Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB. “CIMZIA has the potential to become a valuable option for patients with axSpA and their rheumatologists.”