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Certolizumab pegol superior to placebo for non-radiographic axSpA
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CHICAGO — 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.
In the United States, no drugs are currently approved for non-radiographic axial SpA (axSpA). During a presentation at the ACR/ARHP 2018 Annual Meeting, Atul A. Deodhar, MD, professor of medicine and medical director at the Oregon Health and Science University, said the FDA has previously expressed concern over the lack of knowledge about the natural history of non-radiographic axSpA and the potential for spontaneous remission in patients with objective signs of inflammation.
The C-axSpAnd trial was launched to investigate the outcomes of patients with non-radiographic axSpA and signs of inflammation who received certolizumab pegol (CZP; Cimzia, UCB) — an FDA-approved treatment for active ankylosing spondylitis (AS) — vs. conventional standard care. During the 52-week, placebo-controlled trial, researchers examined the natural history of non-radiographic axSpA, as well as the percentage of patients who achieved spontaneous remission. At any point, changes in background treatment and a shift to open-label treatment were permitted.
For the study, 317 patients were randomly assigned to placebo (n = 158) or 400 mg of CZP at baseline, week 2 and week 4, followed by 200 mg of CZP every 2 weeks (n = 159). The primary endpoint was AS Disease Activity Score Major Improvement (ASDAS-MI), defined as a 2-point reduction in baseline ASDAS or lowest possible ASDAS, which is 0.6. Secondary endpoints included Assessment of Spondyloarthritis International Society 40 (ASAS40) response and signs of inflammation at weeks 12 and 52.
At baseline, the average symptom duration was 8 years in the placebo group and 7.8 years in the CZP group. For both groups, the mean ASDAS was 3.8 points and the Bath AS Function Index (BASFI) was 5.4 points.
At week 52, patients assigned to CZP were more likely to complete double-blind treatment (79% vs. 34%) and less likely to shift to open-label treatment (13% vs. 61%) compared with patients who were assigned to placebo, indicating limited efficacy of standard care in this patient population, Deodhar said.
The primary endpoint of ASDAS-MI was achieved in 35.2% of patients in the CZP arm vs. 6.3% in the placebo arm at week 12, and 47.2% of patients in the CZP arm vs. 7% in the placebo arm at week 52. Sensitivity analyses yielded similar results.
Patients in the CZP arm also had significantly better outcomes in secondary analyses, including:
- ASAS40 response at week 12 (47.8% vs. 11.4%) and week 52 (56.6% vs. 15.8%);
- Bath AS Disease Activity Index (BASDAI) at week 12 (2.95-point reduction vs. 1.08-point reduction) and week 52 (3.62-point reduction vs. 1.32-point reduction); and
- BASFI at week 12 (2.22-point reduction vs. 0.49-point reduction) vs. 2.74-point reduction vs. 0.73-point reduction).
Treatment-related adverse events occurred among 14.6% of patients in the placebo arm and 30.2% in the CZP arm. One patient in the CZP developed a serious infection. No deaths were reported.
“In conclusion, CZP plus standard care was superior to placebo plus standard care for the treatment of patients with non-radiographic axSpA who had objective signs of inflammation,” Deodhar said. “This first 52-week placebo-controlled period was specifically done to find out whether non-radiographic axSpA is self-limiting, and the answer is no, it is not. The C-axSpAnd trial highlights the limitations of current standard of care for this condition.” – by Stephanie Viguers
References:
Deodhar A, et al. Abstract 1868. Presented at: ACR/ARHP Annual Meeting, Oct. 20-24, 2018; Chicago.
Disclosures: Deodhar reports receiving grant/research support and/or consulting fees from AbbVie, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma.