番茄社区

At the recent American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting, researchers reported that treatment with benralizumab (Fasenra) was noninferior to mepolizumab (Nucala) for relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA).

In this second of four exclusive episodes, 番茄社区 brought together three expert leaders in the field -- moderator Michael Wechsler, MD, of National Jewish Health in Denver and lead author on this study, is joined by Flavia Hoyte, MD, also of National Jewish Health, and Leonard Bacharier, MD, of Vanderbilt University Medical Center in Nashville, Tennessee -- for a virtual roundtable discussion on the results of the randomized MANDARA trial.

Click here to watch other episodes in this roundtable series.

Following is a transcript of their remarks:

Wechsler: One of the other exciting studies that was presented at the AAAAI was the MANDARA trial, which was a phase III study evaluating benralizumab versus mepolizumab in patients with EGPA or eosinophilic granulomatosis with polyangiitis. These were patients ... EGPA as you know -- used to be called Churg-Strauss syndrome -- is a disease characterized by asthma, eosinophilia, sinus disease, pulmonary infiltrates, neuropathy, as well as vasculitis in one or more organ. And in this study, patients who were receiving oral corticosteroids of at least 7.5 mg a day were randomized to receive either 30 mg of benralizumab on a monthly basis or 300 mg of mepolizumab on a monthly basis. Mepolizumab has previously been for this indication, and now we're using a slightly different dosing strategy in this study with benralizumab giving it monthly as opposed to every 8 weeks.

And what was demonstrated was that benralizumab met the primary endpoint of the trial and demonstrated non-inferior rates of remission compared to mepolizumab; 59% of benralizumab treated patients achieved remission compared with 56% of mepolizumab treated patients achieved remission. Which remission in EGPA is generally defined as a Birmingham Vasculitis Activity Score of zero, and being on an oral corticosteroid dose of less than or equal to 4 mg a day.

The other important finding of this study was that a higher proportion of patients treated with benralizumab were able to fully taper off of oral corticosteroids by the end of the study; 41% of patients were able to come off of oral corticosteroids with benralizumab, 26% versus the patients treated with mepolizumab. And I think this is clinically meaningful.

In our prior studies, only 3% of patients in the placebo group were able to come off of oral corticosteroids. So having 41% come off of oral corticosteroids with benralizumab is clinically meaningful. Does either of you want to comment on the MANDARA study and the potential implications this may have for some of our patients?

Hoyte: Yeah, I mean, I think it's exciting to have another potential agent here targeting the eosinophilia of EGPA. And I think the approval of mepolizumab was really life-changing for these patients to not have to be on these heavy immune suppressants or high dose of steroids, and so having another option I think is great. The fact that the clinical efficacy was similar and coming off of steroids is always one of our main goals as physicians given all the side effects. So I think this is a really powerful study.

Wechsler: I agree. I think both of these drugs were safe as were the other biologics in the other studies we talked about, and I think they're really an exciting step forward in affirming that eosinophil-targeting biologic treatments really help patients with EGPA achieve remission and taper off of corticosteroids. So I'm very excited about these studies, both this EGPA study as well as the prior asthma studies that we talked about with dupilumab and other biologics.

So thanks for joining us today for this brief roundtable discussion. We will have other roundtable discussions on some of the other exciting findings from the AAAAI. So thanks for joining.

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