Most multi-food allergic children succeeded in longer term regular dietary consumption whether treated with oral immunotherapy (OIT) or omalizumab (Xolair) alone, results from stage 3 of the OUtMATCH trial showed.
After finishing 52 months of multi-food allergy treatment, most patients maintained their tolerance, with 77% of oral immunotherapy recipients and 67% of omalizumab-treated patients continuing dietary consumption as planned at 3 months (P=0.10).
At 6 months post-treatment, those rates remained similar at 65% and 63%, respectively (P=0.80), reported R. Sharon Chinthrajah, MD, of Stanford University in California, at the American Academy of Allergy, Asthma & Immunology annual meeting.
Safety also came out similar in the long-term phase, with most patients reporting some adverse event. Both cases (7%) requiring epinephrine and the three cases (10%) meeting anaphylaxis criteria that were potentially related to dietary consumption occurred in the omalizumab group. One case of eosinophilic esophagitis occurred in the omalizumab group after transition to dietary consumption.
"This real food is like oral immunotherapy in that you could still have allergic reactions to your 'dose,' so you still have to be mindful about monitoring for allergic reactions. But hopefully it gets us a little step closer to interacting with food in a normal way," Chinthrajah told MedPage Today.
It's good news that the two treatments came out similar at the end, she noted: "If one treatment option doesn't feel right, becomes burdensome, you have too many side effects, we can switch pathways and still go towards treating a chronic disease with a different approach."
Co-author Alkis Togias, MD, chief of the Allergy, Asthma, and Airway Biology Branch at the National Institute of Allergy and Infectious Diseases in Rockville, Maryland, agreed: "At least now we know that under appropriate care, you can actually stop either one of these therapies and go into regular food, which is the ultimate goal as opposed to cure patients forever."
Although that fits with clinical experience, there had been little data to prove it, noted co-author Wayne G. Shreffler, MD, PhD, director of the Food Allergy Center at Massachusetts General Hospital and Harvard in Boston.
"One of the dirty secrets about OIT, in a way -- and I have this conversation all the time in clinic -- is there's level one, randomized controlled clinical trial data showing that OIT raises people's thresholds," he said. "But whether or how much it actually helps people lose their allergy over time, that never has been -- and frankly never will be -- an outcome in a randomized clinical trial, because now we don't even have a licensed product. It's just foods."
Stage 3 of OUtMATCH was "at least an effort to get at this question of 'Are we really inducing something like remission in people?'," he said.
The initial stage of the complex trial led to FDA approval of omalizumab for the treatment of immunoglobulin E (IgE)-mediated multi-food allergy in adults and children, ages 1 year and older, to help reduce allergic reactions like anaphylaxis following accidental exposure. It showed that regular omalizumab injections increased the amount of peanut and other foods that multi-food-allergic children could consume without an allergic reaction.
Stage 2 of OUtMATCH included 117 children with confirmed allergy to less than half a peanut and similarly small amounts of at least two other common foods, including milk, egg, cashew, wheat, hazelnut, or walnut. Median age was 7 years, and 55% were boys.
Participants were randomized to receive either double-blind omalizumab and placebo OIT or multi-allergen OIT and placebo injections. Treatment in both groups started with 16 weeks of open-label omalizumab, then at week 9, OIT or placebo OIT was initiated and was escalated to a maintenance goal of 1,000 mg for each participant's study-specific allergens. At week 16, participants transitioned to blinded omalizumab or placebo injections for 44 weeks before being re-challenged.
The 81 who completed this stage went on to stage 3, with a treatment plan for dietary consumption of one to three of their former allergy eliciting foods as determined by their last double-blind food challenge results. For most of them (n=74), that involved peanut, while about half (43) got a plan for consumption of cashew. Walnut, milk, egg, hazelnut, and wheat also were included.
Dietary consumption success meant consuming a median of at least 300 mg per day of allergenic food as indicated in diary records and study team evaluations.
Individual allergens had similar success rates as seen in the primary results, Chinthrajah said. For example, peanut consumption continued for 77% of post-OIT patients and 67% of post-omalizumab patients at 3 months and 65% and 60%, respectively, at 6 months (P=0.43 and 0.80, respectively).
A limitation of the analysis was that participants did not randomly succeed to stage 3 but might represent a selected population who stuck out the treatments long term.
Some patients do well with strict allergen avoidance, Chinthrajah acknowledged. "But for others who are really impacted psychosocially, which many of our families are, there are many treatment options and combination approaches," she said.
"And ultimately the next step is really trying ... to not think every day that you're taking medicine, but you're incorporating foods back into your diet that were previously forbidden," she added.
Disclosures
OUtMATCH was supported by the National Institute of Allergy and Infectious Diseases and the National Center for Translational Sciences.
Chinthrajah disclosed relationships with Genentech and Novartis.
Shreffler disclosed multiple relationships with industry, including Novartis, Allergy Therapeutics, and DVB.
Togias disclosed no relationships with industry.
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