Treating Ankylosing Spondylitis Refractory to TNF-inhibition
Treating Ankylosing Spondylitis Refractory to TNF-inhibition
The IL-1 receptor antagonist anakinra was studied in patients with AS in two open clinical trials published several years ago. In an open study performed in Berlin, 20 patients with active AS refractory to NSAIDs were treated with 100mg anakinra given subcutaneously daily over 24 weeks. Although seven patients did not complete the study, the primary outcome parameter ASAS 40 was achieved in four patients at 24 weeks. Because the mean BASDAI had not decreased significantly, 5.8–4.8 (P>0.05), the study was considered not to support the hypothesis that anakinra works for patients with AS. Furthermore, MRI follow-up examinations (n=10) of the spine had not shown improvement of active inflammatory lesions.
In a 3-month open-label study performed in the United Kingdom, nine patients with active AS who had not sufficiently responded to NSAIDs were treated with anakinra. The potential effects of the drug on axial enthesitis and osteitis based on MRIs of the spine and the sacroiliac joints (SIJ) were systematically evaluated in this study. At week 12, six patients had achieved an ASAS 20 response. Reportedly, 23 out of 38 regions of enthesitis/osteitis determined by MRI at baseline (61%) had either improved or regressed completely. Follow-up examinations of three patients showed sustained response to anakinra for up to 30 months (range 19–30). One patient lost efficacy after 19 months of therapy; two patients continued to respond until the drug was withdrawn because of problems with funding.
Overall, there is little evidence that anakinra may be efficacious from these small open-label trials but randomized controlled studies have not yet been performed.
Anakinra
The IL-1 receptor antagonist anakinra was studied in patients with AS in two open clinical trials published several years ago. In an open study performed in Berlin, 20 patients with active AS refractory to NSAIDs were treated with 100mg anakinra given subcutaneously daily over 24 weeks. Although seven patients did not complete the study, the primary outcome parameter ASAS 40 was achieved in four patients at 24 weeks. Because the mean BASDAI had not decreased significantly, 5.8–4.8 (P>0.05), the study was considered not to support the hypothesis that anakinra works for patients with AS. Furthermore, MRI follow-up examinations (n=10) of the spine had not shown improvement of active inflammatory lesions.
In a 3-month open-label study performed in the United Kingdom, nine patients with active AS who had not sufficiently responded to NSAIDs were treated with anakinra. The potential effects of the drug on axial enthesitis and osteitis based on MRIs of the spine and the sacroiliac joints (SIJ) were systematically evaluated in this study. At week 12, six patients had achieved an ASAS 20 response. Reportedly, 23 out of 38 regions of enthesitis/osteitis determined by MRI at baseline (61%) had either improved or regressed completely. Follow-up examinations of three patients showed sustained response to anakinra for up to 30 months (range 19–30). One patient lost efficacy after 19 months of therapy; two patients continued to respond until the drug was withdrawn because of problems with funding.
Overall, there is little evidence that anakinra may be efficacious from these small open-label trials but randomized controlled studies have not yet been performed.
