Friday, 23 Aug 2019

You are here

FINCH2: Filgotinib in Biologic Refractory Rheumatoid Arthritis

The FINCH2 study has shown that filgotinib, an oral once daily JAK 1 inhibitor, is highly effective in rheumatoid arthritis (RA) patients who failed to respond to prior biologic therapy.

A total of 448 active RA patients were enrolled in a 24 week trial if they had an inadequate response or intolerance to 1 or more biologic disease-modifying antirheumatic drugs, were maintained on their background conventional synthetic DMARDs (csDMARDs). Patients were randomized to either daily filgotinib, 200 mg (n = 148); filgotinib, 100 mg (n = 153); or placebo (n = 148). The primary endpoint was an ACR20 response at week 12. 

Week 12 outcomes showed filgotinib (FIL) to be significantly superior to placebo, with ACR20 responses:

  • FIL 200 mg = 66.0%
  • FIL 100 mg = 57.5%
  • PBO = 31.1%; (both P < .001),

Even in patients who failed 3 or more prior biologic agents, significant ACR20 responses were achieved with FIL 200 mg (70.3%) and FIL 100 mg (58.8%) compared with PBO treated patients (17.6%).

Common adverse events (in 5-10%) included nasopharyngitis, headache, and upper respiratory infections.

There were 4 cases of herpes zoster cases, 1 retinal vein occlusion and no reports of tuberculosis, opportunistic infections, malignancies, gastrointestinal perforations, or deaths.

This is one of the pivotal drug development trials for filgotinib in RA. Gilead is partnering with Galapagos in developing filgotinib for use in RA and is planning to file for FDA approval later this year.


The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

Upadacitinib (RINVOQ) FDA Approved for Rheumatoid Arthritis

The US Food and Drug Administration (FDA) on Friday, August 16, approved AbbVie JAK1 inhibitor, Rinvoq (upadacitinib) for adults with  rheumatoid arthritis with moderately to severely active disease either not responding to, or intolerant of, methotrexate (MTX). 

Are Non-TNF Biologics Superior to TNF inhibitors?

Current ACR and EULAR guidelines list TNF-inhibitors (TNFi) abatacept, rituximab, and tocilizumab as being equally effective after methotrexate or as second line therapies when treating rheumatoid arthritis. An analysis from the Swedish Rheumatology Register shows that the non-TNFi biologic DMARDs (bDMARDs), in particular tocilizumab and rituximab, are more effective than TNFi. 

Rituximab Safety Concerns when Used in anti-TNF Refractory RA

The SUNSTONE study evaluated the long‐term safety of rituximab in rheumatoid arthritis (RA) previously exposed to ≥1 anti–tumor necrosis factor inhibitors (TNFi) and showed a stable, but high, rate of serious infections, opportunistic infections and an overall higher mortality rate.

No Difference Among Biologics in Arthroplasty Infectious Risk

A large administrative claims analysis of rheumatoid arthritis (RA) patients undergoing arthroplasty has shown no difference among biologics with regard to the risk of infections, but corticosteroid use was associated with a dose dependent risk of infection. 

The Annals of Internal Medicine has published an analysis of peri- and postoperative infectious risk among RA patients receiving biologics or glucocorticoids.

Is Methotrexate Necessary with Tofacitinib?

Rheumatoid arthritis patients taking tofacitinib (Xeljanz) plus methotrexate who achieved low disease activity (LDA) may be able to withdraw from the latter agent without significant worsening of disease activity, a researcher reported at EULAR 2019 in Madrid.