Trials begin for GSK drug Mepolizumab for EGPA patients in the USA and Canada

Trials begin for GSK drug Mepolizumab for Patients with Eosinophilic Granulomatosis with Polyangiitis in the USA and Canada

UK-based drug manufacturer GlaxoSmithKline (GSK) has sponsored a Phase III trial to evaluate the efficacy and safety of an investigational IL-5 antagonist mepolizumab to treat patients with EGPA/CSS. This trial is the first ever double-blind, placebo-controlled study to be conducted in patients with EGPA.

Eligible EGPA patients are urged to enroll!

The trial is being conducted as part of an agreement between GSK and the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), where the mechanisms that underlie EGPA will also be investigated to gain a better understanding of disease pathogenisis as well as aberrant eosinophil biology in EGPA as well as other eosinophilic disorders. Dr. Michael Wechsler of National Jewish Health, who has had a ongoing research interest in eosinophilic disorders, is the lead investigator in the USA.

The phase III study, named MEA115921 in the USA and MIRRA in Canada, is a randomized, double-blind study with the purpose of investigating the efficacy and safety of a 300mg dose of mepolizumab (administered subcutaneously every 4 weeks) compared with placebo over a 52-week study treatment period in patients with relapsing or refractory EGPA receiving standard of care therapy including background corticosteroid therapy with or without immunosuppressive therapy. 

A key goal of treatment of EGPA with  mepolizumab is to induce and maintain remission while reducing the use of corticosteroids and other immunosuppressive therapies.

 Enrollment  and investigator information:

In the USA:

Denver/National Jewish, Michael Wechsler, Principal Investigator

Boston/Beth Israel  Deaconess, Peter Weller

Salt Lake City/U Utah, Gerald Gleich

Rochester MN/Mayo Clinic, Ullrich Specks

Bethesda, MD/NIH, Amy Klion

Cleveland/Cleveland Clinic, CaroL Langford

Philadelphia/U Penn, Peter Merkel

 Patients who are interested may contact Lindsay Morehouse, Clinical Research Coordinator National Jewish at morehouseL@njhealth.org, mikewechsler@gmail.com or call the study center at 303-398-1443. Patients will then be matched with centers that would work for them.

 In addition to these centers, some vasculitis and eosinophilic researchers are applying directly to GSK for funding to enroll their patients into this important trial.

 Patients who live in the Washington DC metro, or outskirts, may contact contact the NIH research nurse coordinator directly for the study: Nicole Holland-Thomas 301-402-5969 (nicole.holland2@nih.gov). 

 Canadian patients may contact Dr. Christian Pagnoux, cpagnoux@mtsinai.on.ca or study coordinator Samuyukta Jagadeesh sjagadeesh@mtsinai.on.ca

 This study is also ongoing in Belgium, the UK, Germany, France, Italy and Spain, but enrollment goals are nearly met in those locations.

 Mepolizumab is an investigational fully humanized IgG monoclonal antibody specific for interleukin 5 (IL-5). IL-5 is a cytokine which regulates the growth, activation and survival of eosinophils, the white blood cells that proliferate in EGPA.  Inhibiting IL-5 reduces blood, tissue and sputum eosinophil levels, which in turn reduces eosinophil-mediated inflammation. Interleukin-5 (IL-5) also mediates bone marrow release, tissue survival, maturation and activation of eosinophils. Furthermore, IL-5 levels are increased in patients with EGPA and are associated with disease activity. Consequently, reducing the number of eosinophils and preventing their activation by inhibiting IL-5 appears to be a rational novel approach for EGPA.

 This is a double-blind placebo controlled study, meaning neither the patient nor doctor will know who is receiving the drug. However, flares and disease activity while in the trial will be treated with standard of care.

 During the treatment period, corticosteroid dose will be tapered. The key outcomes in the study focus on evaluation of clinical remission, defined as Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of less than or equal to 4 mg/day prednisolone/prednisone, reduction in disease relapse and reduction in corticosteroid requirement. For many EGPA patients on long term prednisone, with all its side effects, this is a very promising potential trial outcome.

 For eligibility, including both inclusion and exclusion criteria, please visit:

http://clinicaltrials.gov/ct2/show/NCT02020889

Mepolizumab seems to have a good safety and adverse side effect profile, but patients are encouraged to consult with their doctors as well as research previous studies listed on the internet. 

 Following is a quote from a patient who is currently enrolled in the study:

 “I figured that if I got the placebo, it would be no different than what Ihave been doing all along.  Tapering prednisone would increase the risk of a flare, but that is the same risk we run all the time.  A flare is treated the same way it always is, regardless of whether or not you are on the study meds.  For me, the potential benefits outweigh the risks by far.

This drug trial came along at the perfect time for me.  But the drug has the potential to change all of our lives for the better, which I feel pretty good about.  I am glad that the research has the potential to benefit all of us.  It is a very exciting time!”

 

 

 

 

 

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