Background bDMARDs (TNF or IL-17 inhibitors) have been shown to be efficacious in patients with axial spondyloarhritis (axSpA). However, approximately 30–50% of patients who receive a first bDMARD do not respond well. Current practice in these patients is switching to another bDMARD but the scientific evidence for this attitude is sparse.
Objectives To evaluate the efficacy of switching bDMARDs in patients with axSpA.
Methods A systematic literature review until February 2016 was performed using Medline, EMBASE and Cochrane databases. Furthermore, abstracts from the previous EULAR and ACR meetings were reviewed. The research question was formulated according to the PICOS method: Population (axSpA patients); Intervention (bDMARD); Outcome (clinical response); and Setting (longitudinal studies with follow-up ≥12 weeks of follow up including data from ≥50 patients). Data was extracted using a form developed for this specific purpose. The quality of the studies was assessed based on CEBM Oxford. Clinical response in patients who switched to a second bDMARD was determined and compared with the one achieved after receiving the first bDMARD (a TNFi in all cases). Results are shown as median (range) and relative frequencies (%).
Results In total, 7 studies out of 1506 retrieved citations were included. All studies included patients with ankylosing spondylitis (AS). The study design was prospective observational (n=3), retrospective observational (n=2), open-label trial (n=1) and post-hoc analysis from two RCTs (n=1). The level of evidence for all the studies was 4. In these studies, a total of in 4678 patients received a first bDMARD and 1198 patients switched to a second bDMARD (a TNFi in all cases except in 51 patients that switched to secukinumab). Baseline characteristics of patients included in the studies were: 41 (38–44) years old, 67% (64–74) males, 78% (74–89) HLA-B27+ and BASDAI before switching 6.2 (5.3–6.5). The most frequent reason to switch bDMARD was inefficacy, followed by intolerance/adverse events. Median (range) time to assess response after switching was 6 (3–12) months. The criteria to define clinical response were heterogeneous. BASDAI50 was employed in four studies and the percentage of patients who achieved this response after the first and the second bDMARD for each study was: (63% vs 41%), (50% vs 28%), (54% vs 37%), (72% vs 56%), respectively. The response for the other three studies was based on different definitions, being as follows: BASDAI <4 (83% vs 78%), ASAS20 response (67% vs 48%) and retention rate after one year (65% vs 60%). The reason to switch bDMARD (intolerance or inefficacy) was not found as a significant predictor of treatment response in most of the studies. In addition, two studies reported data (n=137 and 11 patients) to evaluate the efficacy of switching to a third bDMARD (TNFi in both cases). The percentage of patients who responded (BASDAI50) to the third TNFi was 30% and 52%, respectively.
Conclusions In patients with AS who do not respond to a first TNFi, switching to another bDMARD (either a TNFi or secukinumab) is efficacious in a considerable number of patients (30–50%). However, the clinical response after receiving a second bDMARD is lower to the one experienced after the first TNFi. Published data for switching to a third bDMARD is very limited.
Disclosure of Interest None declared