Wednesday, 25 Apr 2018

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

FDA Arthritis Panel Split on the Efficacy and Safety of Baricitinib in RA

On Monday, April 23rd the FDA convened the Arthritis Advisory Committee (AAC) to evaluate Lilly’s resubmitted NDA for the approval of the JAK inhibitor baricitinib for use in rheumatoid arthritis (RA). The panel included 15 voting members that included 7 rheumatologists, 3 epidemiologist-statisticians, a hematologist, 2 patient representatives and 2 pharmacologists.

IL-6 Inhibition Most Effective in Polycyclic Systemic JIA

The German Autoinflammatory Disease (AID) registry has studied the effects of the IL-6 inhibitor tocilizumab (TCZ) in systemic juvenile idiopathic arthritis (sJIA) patients and shown a clinical response rate of 35% during the first 12 weeks, and inactive disease and/or remission (with medication) in 75% at 12 months.

Rituximab May Halt ILD in Antisynthetase Syndrome Myositis

A multicenter study assessed patients with the antisynthetase syndrome (AS) and interstitial lung disease (ILD) and found that rituximab (RTX) therapy was associated with either improved or stable pulmonary outcomes in most. 

Anakinra May Attenuate Stroke Outcomes

The journal Stroke has published a trial wherein the use of subcutaneous IL-1Ra (anakinra) was shown to reduce the peripheral inflammatory response in those with an acute ischemic stroke. (Citation source: http://bit.ly/2uoNXEL)

FDA Panel Votes to Favor High Dose Xeljanz in Ulcerative Colitis

Yesterday a FDA advisory panel voted 15-0 in favor of approving Xeljanz (tofacitinib) 10 mg bid for patients with moderate to severe ulcerative colitis.

The US Food and Drug Administration’s (FDA) convened the Gastrointestinal Drugs Advisory Committee Meeting (GIDAC) to assess Pfizers supplemental new drug application for tofacitinib in adult patients with moderately to severely active ulcerative colitis (UC).