Long-term Treatment Suitable for Patients With NraxSpA

Patients treated with certolizumab pegol (CZP) for active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation sustained clinical outcomes reported at 1 year over an additional 2 years of treatment, according to study results published in RMD Open.

“Reduced disease activity, improved patient function, and quality of life achieved in the first year of CZP treatment were observed to be sustained at 3 years after a further 2 years of CZP treatment,” wrote researchers. “Overall, our findings support long-term CZP treatment as a suitable option for patients with nr-axSpA and objective signs of inflammation.”

The follow-up extension study followed a 1-year, double-blind trial of CZP 200 mg every 2 weeks vs placebo. Among 317 patients enrolled in the original trial, 243 patients entered the extension and received open-label CZP for 2 years.

Patients in the initial CZP-randomised group maintained Ankylosing Spondylitis Disease Activity Score and Bath Ankylosing Spondylitis Disease Activity Index scores from week 52 at week 156, according to study authors.

Magnetic resonance imaging of sacroiliac joints at both timepoints also remained low. Down from a baseline average of 7.6, SpondyloArthritis Research Consortium of Canada sacroiliac joint inflammation scores averaged 1.7 at week 52 and 2.4 at week 156.

Treatment-emergent adverse events occurred in 149 patients and was serious in 15 patients. The safety profile of CZP was consistent with previous clinical trial data, reported researchers, and no new safety signals emerged during the extension.

“The most common treatment-emergent adverse events reported during the safety follow-up extension was nasopharyngitis in 26 patients, followed by upper respiratory tract infections in 21 patients,” wrote researchers. “These outcomes are consistent with infections commonly reported as the most frequent treatment-emergent adverse events for patients with nr-axSpA treated with tumor necrosis factor inhibitors.”

Reference:
van der Heijde D, Gensler LS, Maksymowych WP, et al. Long-term safety and clinical outcomes of certolizumab pegol treatment in patients with active non-radiographic axial spondyloarthritis: 3-year results from the phase 3 C-axSpAnd study. RMD Open. 2022;8(1):e002138. doi:10.1136/rmdopen-2021-002138