IMPORTANCE There are currently no approved treatments for peanut allergy. OBJECTIVE To assess the efficacy and adverse events of epicutaneous immunotherapy with a peanut patch among peanut-allergic children. DESIGN, SETTING, AND PARTICIPANTS Phase 3, randomized, double-blind, placebo-controlled trial conducted at 31 sites in 5 countries between January 8, 2016, and August 18, 2017. Participants included peanut-allergic children (aged 4-11 years [n = 356] without a history of a severe anaphylactic reaction) developing objective symptoms during a double-blind, placebo-controlled food challenge at an eliciting dose of 300 mg or less of peanut protein. INTERVENTIONS Daily treatment with peanut patch containing either 250 μg of peanut protein (n = 238) or placebo (n = 118) for 12 months. MAIN OUTCOMES AND MEASURES The primary outcome was the percentage difference in responders between the peanut patch and placebo patch based on eliciting dose (highest dose at which objective signs/symptoms of an immediate hypersensitivity reaction developed) determined by food challenges at baseline and month 12. Participants with baseline eliciting dose of10mgorlesswererespondersiftheposttreatmentelicitingdosewas300mgormore;participants with baseline eliciting dose greater than 10 to 300 mg were responders if the posttreatment eliciting dose was 1000 mg or more. A threshold of 15% or more on the lower bound of a 95% CI around responder rate difference was prespecified to determine a positive trial result. Adverse event evaluation included collection of treatment-emergent adverse events (TEAEs). RESULTS Among 356 participants randomized (median age, 7 years; 61.2% male), 89.9% completed the trial; the mean treatment adherence was 98.5%. The responder rate was 35.3% with peanut-patch treatment vs 13.6% with placebo (difference, 21.7% [95% CI, 12.4%-29.8%; P < .001]). The prespecified lower bound of the CI threshold was not met. TEAEs, primarily patch application site reactions, occurred in 95.4% and 89% of active and placebo groups, respectively. The all-causes rate of discontinuation was 10.5% in the peanut-patch group vs 9.3% in the placebo group. CONCLUSIONS AND RELEVANCE Among peanut-allergic children aged 4 to 11 years, the percentage difference in responders at 12 months with the 250-μg peanut-patch therapy vs placebo was 21.7% and was statistically significant, but did not meet the prespecified lower bound of the confidence interval criterion for a positive trial result. The clinical relevance of not meeting this lower bound of the confidence interval with respect to the treatment of peanut-allergic children with epicutaneous immunotherapy remains to be determined.

14 of those (77.8%) maintained an eliciting dose of > _1000 mg at month 38. Local patch-site skin reactions were common but decreased over time. There was no treatment-related epinephrine use in years 2 or 3. Compliance was high (96.9%), and withdrawals due to treatment-related adverse events were low (1%). Conclusions: These results demonstrate that daily EPIT treatment for peanut allergy beyond 1 year leads to continued response from a well-tolerated, simple-to-use regimen. (J

There is little evidence to address the hypothesis that the ingestion of baked hen's egg or cow's milk results in more patients outgrowing their hen's egg or cow's milk allergy respectively. Data are required from a trial comparing the resolution rates of baked-tolerant participants who are randomized to ingest or avoid baked products to assess the accuracy of this hypothesis.

A 49 year old woman with a four year history of rheumatoid arthritis had received aspirin 4 g/day and, for the past nine months, oral methotrexate 7 5-15 mg/week. Her blood counts were always normal during treatment. The patient presented with fever after dental extraction. The total white blood count was 1 1 x 109/1. Blood and urine cultures showed no growth and a chest radiograph was normal. She was admitted to hospital for four days and given intravenous penicillin and gentamicin. Three days later she was readmitted with a fever of 39 6°C, shortness of breath, and diarrhoea. The total white cell count was 3.5 x 109/1 (54% neutrophils, 1% band forms, 17% lymphocytes, 28% monocytes). A chest radiograph showed increased interstitial markings bilaterally, and a Grocott-Gomori methenamine silver nitrate stain of a transbronchial biopsy specimen showed P carinii. The patient required ventilatory support for nine days. She was treated with trimethoprim-sulphamethoxazole (20 mg/ 100 mg/kg a day) and later pentamidine (4 mg/kg a day), and was discharged after three weeks. She denied risk factors for human immunodeficiency virus infection, and the result of a test for antibody to the human immunodeficiency virus type 1 (HIV-1) by ELISA was negative. She has been treated with sulphasalazine, aspirin, and prednisone 5-10 mg/ day to control her symptoms of arthritis for 60 months since discharge, with no evidence of lung disease. PATIENT 3 A 64 year old woman with a 15 year history of rheumatoid arthritis had been treated for the past 30 months with sulindac 400 mg/day, prednisone 7 0 mg/day, and oral methotrexate 15 mg/week. Her blood count was always normal. She was admitted to hospital with weakness, chills, night sweats, dyspnoea, and cough. Her temperature was 39-4°C, and lung examination showed bilateral basal crackles.The total white cell count was 2-2 x 109/l (88% neutrophils, 2% band forms, 7% lymphocytes, 2% eosinophils, 1% basophils). The chest radiograph showed diffuse reticulonodular interstitial shadowing. GrocottGomori methenamine silver nitrate staining of bronchoalveolar lavage fluid showed P carinii. Despite ventilatory support and treatment