OnMedica | April 2019 | Immunotherapy raises risk in peanut allergy
A systematic review (SR) that reviewed the efficacy and safety of oral immunotherapy versus allergen avoidance or placebo (no oral immunotherapy) for peanut allergy, has concluded that current oral immunotherapy treatments result in a large increase in anaphylaxis and other allergic reactions, rather than preventing them as intended.
The SR included 12 studies randomised controlled trials from the USA, UK, Europe and Australia with more than 1,000 patients who were followed for a year compared with allergen avoidance or placebo, current oral immunotherapy increases risk.
The authors writing in The Lancet, say that their findings favour avoidance over current forms of oral immunotherapy if a patient wishes to avoid peanut-induced anaphylaxis and allergic reactions, and that the increased risk of reactions associated with these regimens might be a substantial barrier to widespread adoption by patients with peanut allergies.
They say their findings highlight the gap between outcomes measured in the clinic and the allergy relief outcomes that patients desire after oral immunotherapy for peanut allergy (via OnMedica)
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Oral immunotherapy is an emerging experimental treatment for peanut allergy, but its benefits and harms are unclear. We systematically reviewed the efficacy and safety of oral immunotherapy versus allergen avoidance or placebo (no oral immunotherapy) for peanut allergy.
In the Peanut Allergen immunotherapy, Clarifying the Evidence (PACE) systematic review and meta-analysis, we searched MEDLINE, EMBASE, Cochrane Controlled Register of Trials, Latin American & Caribbean Health Sciences Literature, China National Knowledge Infrastructure, WHO’s Clinical Trials Registry Platform, US Food and Drug Administration, and European Medicines Agency databases from inception to Dec 6, 2018, for randomised controlled trials comparing oral immunotherapy versus no oral immunotherapy for peanut allergy, without language restrictions. We screened studies, extracted data, and assessed risk of bias independently in duplicate. Main outcomes included anaphylaxis, allergic or adverse reactions, epinephrine use, and quality of life, meta-analysed by random effects. We assessed certainty (quality) of evidence by the GRADE approach. This study is registered with PROSPERO, number CRD42019117930.
12 trials (n=1041; median age across trials 8·7 years [IQR 5·9–11·2]) showed that oral immunotherapy versus no oral immunotherapy increased anaphylaxis risk, anaphylaxis frequency, and epinephrine use similarly during build-up and maintenance . Oral immunotherapy increased serious adverse events, and non-anaphylactic reactions , I 2=0%, high-certainty; upper tract respiratory reactions: 1·36, I 2=0%, moderate-certainty; lower tract respiratory reactions: 1·55, I 2=28%, moderate-certainty). Passing a supervised challenge, a surrogate for preventing out-of-clinic reactions, was more likely with oral immunotherapy. Quality of life was not different between groups (combined parents and self report. Findings were robust to IRR, trial sequential, subgroup, and sensitivity analyses.
In patients with peanut allergy, high-certainty evidence shows that available peanut oral immunotherapy regimens considerably increase allergic and anaphylactic reactions over avoidance or placebo, despite effectively inducing desensitisation. Safer peanut allergy treatment approaches and rigorous randomised controlled trials that evaluate patient-important outcomes are needed.