BACKGROUND Studies have suggested an association between frequent acetaminophen use and asthma-related complications among children, leading some physicians to recommend that acetaminophen be avoided in children with asthma; however, appropriately designed trials evaluating this association in children are lacking. METHODS In a multicenter, prospective, randomized, double-blind, parallel-group trial, we enrolled 300 children (age range, 12 to 59 months) with mild persistent asthma and assigned them to receive either acetaminophen or ibuprofen when needed for the alleviation of fever or pain over the course of 48 weeks. The primary outcome was the number of asthma exacerbations that led to treatment with systemic glucocorticoids. Children in both treatment groups received standardized asthma-controller therapies that were used in a simultaneous, factorially linked trial. RESULTS Participants received a median of 5.5 doses (interquartile range, 1.0 to 15.0) of trial medication; there was no significant between-group difference in the median number of doses received (P = 0.47). The number of asthma exacerbations did not differ significantly between the two groups, with a mean of 0.81 per participant with acetaminophen and 0.87 per participant with ibuprofen over 46 weeks of follow-up (relative rate of asthma exacerbations in the acetaminophen group vs. the ibuprofen group, 0.94; 95% confidence interval, 0.69 to 1.28; P = 0.67). In the acetaminophen group, 49% of participants had at least one asthma exacerbation and 21% had at least two, as compared with 47% and 24%, respectively, in the ibuprofen group. Similarly, no significant differences were detected between acetaminophen and ibuprofen with respect to the percentage of asthma-control days (85.8% and 86.8%, respectively; P = 0.50), use of an albuterol rescue inhaler (2.8 and 3.0 inhalations per week, respectively; P = 0.69), unscheduled health care utilization for asthma (0.75 and 0.76 episodes per participant, respectively; P = 0.94), or adverse events. CONCLUSIONS Among young children with mild persistent asthma, as-needed use of acetaminophen was not shown to be associated with a higher incidence of asthma exacerbations or worse asthma control than was as-needed use of ibuprofen. (Funded by the National Institutes of Health; AVICA ClinicalTrials.gov number, NCT01606319.)

Toll-like receptor-9 agonism with CYT003 showed no additional benefit in patients with insufficiently controlled moderate-to-severe allergic asthma receiving standard inhaled glucocorticosteroid therapy with or without LABAs.

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BackgroundMepolizumab reduces blood eosinophils with concomitant clinical improvement in some hypereosinophilic syndromes and eosinophilic asthma.ObjectivesTo investigate the efficacy and safety of mepolizumab in patients with eosinophilic granulomatosis with polyangiitis (EGPA, Churg-Strauss).MethodsWe conducted a Phase III, randomised, placebo-controlled, double-blind, parallel group, multi-centre study (NCT02020889) in patients with EGPA and a history of relapsing or refractory disease on stable therapy with prednisolone/prednisone ≥7.5–≤50mg/day with or without additional immunosuppressive therapy for ≥4 weeks. Patients were randomised 1:1 to receive mepolizumab 300mg or placebo subcutaneously, in addition to standard of care, every 4 weeks for 52 weeks. After Week 4, glucocorticoid dose could be tapered, per physician judgment, according to a suggested standard of care protocol. Co-primary endpoints (intent-to-treat [ITT] analysis) were accrued duration of remission (Birmingham Vasculitis Activity Score [BVAS]=0, prednisolone/prednisone dose ≤4mg/day) over 52 weeks; and the proportion of patients in remission at both Weeks 36 and 48. Secondary endpoints included average glucocorticoid dose during Weeks 49–52 and time to first EGPA relapse. Safety was also assessed.ResultsThe ITT population included 136 randomised patients (mepolizumab n=68, placebo n=68). Baseline characteristics were similar between groups. Duration of remission accrued over 52 weeks was significantly prolonged with mepolizumab vs placebo (odds ratio: 5.91 [95% confidence interval [CI]: 2.68,13.03]; p<0.001); a significantly higher proportion of patients were in remission at Weeks 36 and 48 (32% vs 3%, odds ratio: 16.74 [95% CI: 3.61,77.56]; p<0.001). Significant reductions in average daily prednisolone/prednisone dose during Weeks 49–52 were seen with mepolizumab vs placebo (odds ratio: 0.20[95% CI: 0.09,0.41]; p<0.001). Median (range) prednisolone/prednisone dose during Weeks 49–52 was 5.0 (0.0–113.4)mg/day in the mepolizumab group and 10.0 (0.0–46.3)mg/day in the placebo group. Time to first EGPA relapse was significantly longer with mepolizumab vs placebo (hazard ratio: 0.32[95% CI: 0.21,0.50] ;p<0.001). Rates of adverse events (AEs) and serious AEs were similar for mepolizumab and placebo.ConclusionsTreatment with mepolizumab significantly increased the likelihood and duration of remission, while reducing glucocorticoid use, in patients with EGPA, with a safety profile consistent with previous studies in severe asthma and EGPA. This demonstrates consistent and meaningful clinical benefits of mepolizumab in patients with EGPA.AcknowledgementsFunding: GSK [115921] in collaboration with NIAID [U01 AI097073] and the Division of Intramural Research, NIAID, NIH). Abstract submitted to ATS 2017.Disclosure of InterestM. Wechsler Consultant for: Teva, AstraZeneca, BSCI, GSK, Novartis, sanofi, Vectura, Sunovion, Regeneron, Ambit bioscience, Meda, Mylan, Gliacure, Tunitas, Genentech, Theravance, Neurotronic, Sentien, P. Akuthota Grant/research sup...

Asthma remains one of the most prevalent and costly diseases in the United States. Asthma accounts for a significant amount of direct medical expenditures and indirect cost from days lost at school and work. Modern understanding of its complex pathogenesis has allowed recognition of the heterogeneity of the disease across populations and the various inflammatory pathways that drive airway inflammation in asthma. Interleukins play important roles in both eosinophilic and noneosinophilic asthma, and anti-interleukin therapy will allow for a targeted, personalized approach to asthma management. With the success of anti-interleukin (IL) -4, IL-5, and IL-13 therapy in recent large trials among specific populations of asthmatics, it is likely that targeted anti-interleukin therapy will be approved for use in the near future. It will be important for clinicians and pharmacists to understand their risks, benefits, and proper indications.