Monday, 26 Jun 2017

You are here

Tofacitinib Effective in Ulcerative Colitis

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. 

Disclosures: 
The author has received research/grant financial support on this subject

Add new comment

More Like This

Supreme Court Decision Favors Earlier Biosimilar Adoption

On Monday June 11th, the US Supreme Court unanimously ruled that biosimilar manufacturers can bring their drugs to market faster by eliminating the provision that the biosimar manufacturer had to give the innovator company 180 days notice before launching the new biosimilar.

Upadacitinib Effective in Rheumatoid Arthritis

AbbVie released the preliminary results of a rheumatoid arthritis trial wherein its Jak inhibitor, upadacitinib, was tested against placebo, and shown to be superior in established RA patients who have failed prior DMARD therapy.

Biosimilar Reports – May 2017

Biosimilars continue to command a great deal of research, development and attention given the promise of significant cost savings and potentially wider use for those in need. Biosimilar Reports is an ongoing series dedicated to advances, discussions and developments in biosimilar agents intended for use by rheumatologists. 

Anti-IL-5 Success in Eosinophilic Granulomatosis with Polyangiitis

The NEJM reports success when using mepolizumab (anti-IL-5 monoclonal antibody) in a 52 week study of patients with eosinophilic granulomatosis with polyangiitis (EGPA).

Actemra - First FDA Approved Drug for Giant Cell Arteritis

The FDA has approved subcutaneous tocilizumab for use in Giant Cell Arteritis based on the phase III GiACTA study that demonstrated that TCZ with steroids was superior to steroid therapy alone.