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Tofacitinib is currently approved for use in rheumatoid arthritis, but is being studied in numerous other inflammatory conditons including spondylitis, psoriasis, psoriatic arthritis, and has also been studied in patients with ulcerative colitis (UC).
The NEJM has reported the results of 3 randomized, double-blind, placebo-controlled trials of 10 mg bid tofacitinib therapy in adults with ulcerative colitis - these include the OCTAVE Induction 1 and 2 trials (598 and 541 patients) and the OCTAVE Sustain trial (593 patients) wherein those responding to induction therapy, receive maintenance therapy with tofacitinib (either 5 mg or 10 mg twice daily) or placebo for 52 weeks. The primary end point was remission at 52 weeks.
In OCTAVE 1, the induction trial, remission at 8 weeks was the primary endpoint that was achieved in 18.5% of tofacitinib (10 mg bid) patients versus 8.2% of those on placebo (P=0.007).
The OCTAVE Induction 2 trial, remission occurred in 16.6% versus 3.6% (P<0.001).
In the OCTAVE Sustain trial, those responding were re-randomized to either 5 mg or 10 mg bid tofacitinib or placebo and followed for 52 weeks. Remission was seen in 34.3%, 40.6% and 11.1% of thosed taking tofacitinib 5 mg, tofacitinib 10 mg and the placebo group respectively (P<0.001 for both tofa groups vs. placebo).
Serious adverse events and serious infections were not different between groups, but there were more episodes of herpez zoster and hyperlipidemia in those treated with tofacitinib.
These trials suggest the induction efficacy of tofacitinib but only at the 10 mg bid dose - a dose that has not yet been FDA approved in the US.