BACKGROUND:

Radiographic axial spondyloarthritis (r-axSpA) is a chronic, gradually progressive inflammatory disease of the spine, leading to high disability rates in young working age patients. This is the first network meta-analysis (NMA) assessing efficacy and safety of netakimab together with other biologics for the treatment of r-axSpA.

OBJECTIVES:

To compare the efficacy and safety of biologics, approved and reimbursed in Russia (netakimab, secukinumab, ustekinumab, infliximab, adalimumab, etanercept, golimumab, certolizumab pegol) in adults with r-axSpA.

METHODS:

We performed the literature search in Pubmed database and Cochrane library, as well as in reference lists of original articles to identify eligible publications of phase II, III RCTs. We assessed these RCTs for the risk of bias and possible sources of heterogeneity. Finally, we conducted NMA using random effects model to synthesize evidence obtained from selected studies.

RESULTS:

Overall, we selected 20 articles and 1 unpublished manuscript from BIOCAD for quantitative and qualitative synthesis. Efficacy outcomes included ASAS 20, ASAS 40, ASAS 5/6, BASDAI 50, BASDAI change, BASFI change, assessed at week 16. Safety was defined as the proportion of patients suffering at least one adverse event (AE) during the first 16 weeks of treatment. NMA demonstrated that netakimab is statistically more effective than other biologics and placebo in terms of ASAS 20 response. Also, netakimab has a statistically significant benefit in terms of ASAS 40 and ASAS 5/6 response over placebo, adalimumab, secukinumab, and etanercept; in terms of BASDAI change - over placebo and secukinumab. All biologics demonstrated similar efficacy profile in terms of BASDAI 50 and BASFI change and were superior to placebo. As for safety outcomes, we found no statistically significant difference between the interventions and placebo.

CONCLUSIONS:

Results suggest that except for ASAS 20, ASAS 40 and ASAS 5/6 outcomes, all biologics have comparable efficacy and similar safety profile.