Thursday, 26 Apr 2018

You are here

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).

EGPA, previously known as Churg-Strauss vasculitis is an eosinophilic vasculitis that has often been managed as other systemic necrotizing vasculitis.  Given the eosinophilic component, Weschler and coworkers studied the efficacy and safety of mepolizumab, an anti–interleukin-5 monoclonal antibody, in EGPA.

The NEJM reports on a 136 patients study with relapsing or refractory EGPA patients on stable doses of steroids were randomized to either 300 mg of mepolizumab or placebo, administered subcutaneously every 4 weeks, for 52 weeks. The two primary end points were the accrued weeks of remission over a 52-week period, and the remission rates at both week 36 and week 48.

The mepolizumab were 6 times more likely to have more accrued more weeks of remission than placebo (28% vs. 3%).

The anti-IL-5 mAb also had a higher percentage of remissions at both week 36 and week 48 (32% vs. 3%).  Non-remission was seen in 47% on mepolizumab compared to 81% on placebo.

The annualized relapse rate 50% lower in the mepolizumab group, compared to the placebo group and there was less steroid use in the active treatment group, with 18% of the mepolizumab patients being able to discontinue prednisone completely..

Although only half the participants treated with mepolizumab had protocol-defined remission, this novel biologic intervention represents a new and significant advance in the treatment of EGPA.

An accompanying NEJM editorial by Drs.Djukanovic and O'Byrnes (http://buff.ly/2qW3qsJ) commented "Although the trial was powered to evaluate relapses on the basis of a worsening condition in any of three categories (asthma, vasculitis, and sinonasal disease alone or in combination), the benefit of treatment was slightly greater with regard to relapses defined according to exacerbating asthma-based or sinonasal-based symptoms. This finding suggests that the vasculitic component of eosinophilic granulomatosis with polyangiitis may respond less well to mepolizumab than do other components of the disease."   They comment that additional trials with this agent are needed and that further study of its possible synergism azathioprine, cyclophosphamide or other immunosuppressants would be welcomed..

Disclosures: 
The author has no conflicts of interest to disclose related to 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).