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Tofacitinib Seen as Safe, Effective in Patients With Ankylosing Spondylitis
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Tofacitinib — in 5-mg and 10-mg dose regimens twice per day — was effective in patients with ankylosing spondylitis and showed a similar 12-week safety profile to its other indications, according to results of a recently published phase 2 study.
Désirée van de Heijde, MD, PhD, in the Department of Rheumatology at Leiden University Medical Center in the Netherlands, and colleagues performed a 16-week, phase 2 trial of patients randomized to receive either placebo (n = 51) or tofacitinib at 2 mg (n = 52), 5 mg (n = 52) or 10 mg (n = 52). The primary efficacy endpoint was Assessment of Spondyloarthritis International Society 20% improvement (ASAS20) response rate at week 12. Secondary endpoints included disease activity, patient-reported outcomes and MRI of sacroiliac joints and spine. The final 4 weeks of the trial were a washout.
Researchers found placebo had an ASAS20 response rate of 41.2% compared with 55.8% for 10-mg tofacitinib, 80.8% for 5-mg tofacitinib and 51.9% for 2-mg tofacitinib doses. The 2-mg and 10-mg tofacitinib groups did not have a significantly higher response rate than the placebo group. Secondary endpoints showed greater improvements with 5-mg and 10-mg tofacitinib doses and objective endpoints showed a clear dose response. In addition, adverse events were similar across treatment groups. By week 16, dose-dependent lab outcome changes returned close to baseline measures. – by Will Offit
Disclosure: van de Heijde is a consultant for AbbVie, Amgen, AstraZeneca, Augurex, BMS, Boehringer Ingelheim, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli Lilly, Galapagos, GSK, Janssen Biologics, Merck, Novartis, Novo Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, UCB and Vertex; and is director of Imaging Rheumatology.
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