Friday, 19 Jan 2018

You are here

Tofacitinib Scores in TNF inhibitor Resistant Psoriatic Arthritis

Mease et al has reported in the NEJM the results of a phase 3 trial showing tofacitinib (Tofa) to be significantly more effective than placebo in active psoriatic arthritis (PsA) patients who previously failed to respond to tumor necrosis factor inhibitor (TNFi) therapies. 

In a 6 mont trial, 395 PsA patients were randomized to receive either ofa 5 mg bid, Tofa 10 mg bid or placebo (PBO) patients who were switched to either 5 mg or 10 mg bid after 3 months. THe primary enpoints were ACR20 response and change in HAQ-DI at 3 months.

The ACR20 responses at 3 months were 

  • PBO 24%
  • Tofa 5 mg 50%
  • Tofa 10 mg 47% P<0.001 for both comparisons vs PO
  • HAQ-DI score decreased −0.39 and −0.35, as compared with −0.14 (P<0.001)

Serious adverse events occurred in 4% of the patients who received the 5-mg dose of tofacitinib continuously and in 6% who received the 10-mg dose continuously. Over the course of 6 months, there were four serious infections, three herpes zoster infections, one myocardial infarction, and one ischemic stroke among the patients who received tofacitinib continuously.

These data were presented to the FDA and the Arthritis Advisory Committee in August 2017 and in part, lead to unanimous backing from the committee for drug approval. 

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

Add new comment

More Like This

Salt Drives Gut-Brain Connection via IL-17

A study from Nature Neuroscience shows that a high salt diet may mediate neurovascular disease by altering microbiome and the expansion of TH17 cells in the small intestine, thereby increasing plasma interleukin-17 (IL-17) and its subsequent effects on endothelium in the brain.

MEASURE 3 Study - Anti-IL17 Benefits Persist in Spine Disease

Patients with ankylosing spondylitis (AS) have shown rapid and sustained responses to secukinumab (Cosentyx) in a third phase III trial that includes a higher dose of this anti-interleukin-17A monoclonal antibody, researchers reported.

Therapeutic Update: 5 Questions on FDA Hearing for Tofacitinib in PsA (Best of 2017)

In this Therapeutic Update, Drs. Mease, Gibofsky and Cush answer five questions regarding the August 3rd FDA Arthritis Advisory Committee meeting that reviewed the potential approval of tofacitinib (Xeljanz) in patients with active psoriatic arthritis. The panel was nearly unanimous (10-1) in favor of the efficacy and safety profile of of tofacitinib, and similarly voted 10-1 to approve this drug for use in PsA. Final decisions on these recommendations from the AAC panel will be made at a later date by the FDA. 

Cardiac Disturbances Increased in Spondyloarthritis

A prospective Swedish study between 2001–2009 found a higher risk of aortic regurgitation, pacemaker, AV block and atrial fibrillation in SpA, AS, uSpA and PsA patients.

FDA Approves Xeljanz for Use in Psoriatic Arthritis

Pfizer Inc. announced today that the United States Food and Drug Administration (FDA) has approved Xeljanz (tofacitinibi) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).