Allergy
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Regulatory approaches for allergen immunotherapy (AIT) products and the availability of high-quality AIT products are inherently linked to each other. While allergen products are available in many countries across the globe, their regulation is very heterogeneous. First, we describe the regulatory systems applicable for AIT products in the European Union (EU) and in the United States (US). ⋯ While AIT products are commonly classified as biological medicinal products, they are made available by varying types of procedures, most commonly either by obtaining a marketing authorization or by being distributed as named patient products. Exemptions from marketing authorizations in exceptional cases, as well as import of allergen products from other countries, are additional tools applied by countries to ensure availability of needed AIT products. Several challenges for AIT products are apparent from this analysis and will require further consideration.
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Randomized Controlled Trial Multicenter Study Comparative Study
Comparison of roflumilast, an oral anti-inflammatory, with beclomethasone dipropionate in the treatment of persistent asthma.
Roflumilast is an oral, once-daily phosphodiesterase 4 inhibitor with anti-inflammatory activity in development for the treatment of asthma. Roflumilast was compared with inhaled beclomethasone dipropionate (BDP) in patients with asthma. ⋯ Once daily, oral roflumilast 500 microg was comparable with inhaled twice-daily BDP (400 microg/day) in improving pulmonary function and asthma symptoms, and reducing rescue medication use in patients with asthma.
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Review Meta Analysis
Allergen immunotherapy for IgE-mediated food allergy: a systematic review and meta-analysis.
The European Academy of Allergy and Clinical Immunology (EAACI) is developing Guidelines for Allergen Immunotherapy (AIT) for IgE-mediated Food Allergy. To inform the development of clinical recommendations, we sought to critically assess evidence on the effectiveness, safety and cost-effectiveness of AIT in the management of food allergy. ⋯ AIT may be effective in raising the threshold of reactivity to a range of foods in children with IgE-mediated food allergy whilst receiving (i.e. desensitization) and post-discontinuation of AIT. It is, however, associated with a modest increased risk in serious systemic adverse reactions and a substantial increase in minor local adverse reactions. More data are needed in relation to adults, long term effects, the impact on QoL and the cost-effectiveness of AIT.
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Review Case Reports
Periodic fever syndromes: a diagnostic challenge for the allergist.
The objective was to present a case of periodic fever with aphthous stomatitis, pharyngitis and cervical adenitis (PFAPA), summarize the medical literature on PFAPA, review the differential diagnosis and suggest a diagnostic approach to periodic fevers in children. A PubMed search was conducted for all case reports and series of patients with PFAPA. The references of these papers yielded further case reports. ⋯ Effective treatment options and long-term prognosis varies among these syndromes. Children with periodic fever or autoinflammatory syndromes sometimes present to an Allergy/Immunology clinic for immunologic evaluation. It is important for the Allergy/Immunology specialist to be familiar with the clinical presentation, diagnostic approach and treatment of these conditions.