Current controversies and challenges in allergic rhinitis management

Abstract

There are many obstacles in the path of effective allergy management, in general, and allergic rhinitis (AR) control, in particular. Chief among them are: insufficient symptom relief in some patients provided by some currently considered first-line AR treatments in real life; an over-reliance on randomized controlled trials to direct AR guideline recommendations; the need for a broader interpretation of the AR evidence base (to include randomized controlled trials and real-life studies); poorly designed and interpreted studies; and lack of an AR control concept and common language of control. These controversies are fully reviewed here and challenging solutions have been presented.

Keywords:

• allergic rhinitis
• clinical relevance
• control
• guidelines
• randomized controlled trials
• real life

Financial & competing interests disclosure

This paper has been supported by an unrestricted educational grant from Meda. D Price has board membership with Aerocrine, Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Meda, Mundipharma, Napp, Novartis and Teva. Consultancy: A Almirall, Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Meda, Mundipharma, Napp, Novartis, Pfizer and Teva; grants and unrestricted funding for investigator-initiated studies from UK National Health Service, British Lung Foundation, Aerocrine, AKL Ltd, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Eli Lilly, GlaxoSmithKline, Meda, Merck, Mundipharma, Napp, Novartis, Orion, Pfizer, Respiratory Effectiveness Group, Takeda, Teva and Zentiva; payments for lectures/speaking: Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Meda, Merck, Mundipharma, Novartis, Pfizer, SkyePharma, Takeda and Teva; payment for manuscript preparation: Mundipharma and Teva; patents (planned, pending or issued): AKL Ltd; payment for the development of educational materials: GlaxoSmithKline, Novartis; stock/stock options: shares in AKL Ltd which produces phytopharmaceuticals and owns 80% of Research in Real Life Ltd and its subsidiary social enterprise Optimum Patient Care; received payment for travel/accommodations/meeting expenses from Aerocrine, Boehringer Ingelheim, Mundipharma, Napp, Novartis and Teva; funding for patient enrollment or completion of research: Almirral, Chiesi, Teva and Zentiva; and peer reviewer for grant committees: Medical Research Council (2014), Efficacy and Mechanism Evaluation program (2012), HTA (2014). P Smith has received honoraria for GSK, MSD, Mundipharma and Meda. P Hellings is the recipient of unrestricted research grants of Meda, Stallergenes and ALK. N Papadopoulos has received grants from GSK, Nestle and Merck; provided consultancy to GSK, Abbvie, Novartis, Menarini, Meda and Alk-Abello; is on the speakers bureau for Novartis, Allegopharma, Uriach, GSK, Stallergenes and MSD; and has provided educational presentations for Abbvie, Sanofi and Meda. W Fokkens has received an educational grant from MEDA and research grants from GSK, Biopharma. A Muraro has lectured for Meda, Nutricia, Novartis, Allergopharma; was the Secretary General of EAACI in 2013–2015 and the President of EAACI from 2015 to 2017. R Murray is the Director of a Medical and Scientific Affairs consultancy, who has provided consultancy services to Meda, MACVIA ARIA and RIRL. P Demoly is a consultant (and a speaker) for Stallergenes, Circassia, ALK, DBV and Chiesi, and was a speaker for Merck, Astra Zeneca, Pierre Fabre Médicaments, Menarini, Allergopharma, Allergy Therapeutics Ltd, Thermo Fischer Scientific and GlaxoSmithKline. G Scadding has received research grants from GSK and ALK, as well as honoraria for articles, consulting, lectures/chairing and/or advisory boards from ALK, Bausch & Lomb, Church & Dwight, Circassia, GSK, Groupo Uriach, Meda, Merck, Ono, Shionogi and Stallergenes. J Mullol is or has been a member of national and international scientific advisory boards (consulting), received fees for lectures, and grants for research projects from ALK-Abelló, Boehringer Ingelheim, Crucell, Esteve, FAES, GSK, Hartington Pharmaceuticals, Johnson & Johnson, Meda Pharma, MSD, Novartis, Pierre Fabre, Sanofi-Aventis, Schering Plough, UCB, Uriach Group and Zambon. P Lieberman is a speaker for Meda, Teva, Merck, Genentech, Mylan, and a consultant for Sanofi, Novartis, Genentech and Mylan. C Bachert is on the speaker’s bureau for Meda. R Mösges receives personal fees, or grants from ALK-Abello, Allergy Therapeutics, Allergopharma, Bencard, BiotechTools, Bayer, GSK, HAL, Johnson + Johnson, Lofarma, MSD, Menarini, Faes, Novartis, Leti, Optima, AIPrevent, Servier, Stada, Stallergenes, UCB, Ursapharm, Bitop, Hulka, Arthrocare, Meda and Ohropax. He has received non-financial support from Greer, Roxall, UCB and Atmos. Outside the submitted work, Ralph Mösges is a member of the guidelines task force of the German Academy of Otorhinolaryngology. He is the chairman of ISCOANA, the International Standardization Committee of the European Rhinologic Society (ERS), the Chairman of the ENT-section of the European Academy of Allergy, Asthma and Clinical Immunology (EAACI) and a Vice-president of INTERASMA. D Ryan is paid consultancy fees by Stallergenes, Uriach and Teva. He has lectured on behalf of Meda, GSK, AZ, Chiesi, Thermo Fisher, Boehringer, Novartis and Almirall. He is the Director of Health Strategy at Optimum Patient Care. J Bousquet has received honoraria for scientific and advisory boards: Almirall, Meda, Merck, MSD, Novartis, Sanofi-Aventis, Takeda, Teva, Uriach; lectures during meetings for the following: Almirall, AstraZeneca, Chiesi, GSK, Meda, Menarini, Merck, MSD, Novartis, Sanofi-Aventis, Takeda, Teva, Uriach; and is on the Board of Directors for Stallergenes. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Key issues

• Controversy 1: Allergic rhinitis (AR) is becoming ever more challenging to treat, with intranasal corticosteroids providing insufficient symptom relief for many patients.

• Challenge 1: There is a need for new AR treatment options which provide faster and more complete symptom relief than intranasal corticosteroids.

• Controversy 2: AR treatment guidelines rely predominantly on evidence generated from randomized controlled trials (RCTs). Currently, RCTs are the best way of assessing size of a treatment effect and are necessary not only for drug registration but also to establish general and objective evidence levels and recommendations. However, they cannot (nor are they expected to) answer every clinical question.

• Challenge 2: High-quality evidence from effectiveness studies should be considered for inclusion in guidelines to complement data already gathered from well-designed RCTs.

• Controversy 3: Currently, AR management guidelines grade the evidence in such a way that they may not always be readily transferable to routine clinical care.

• Challenge 3: A simplified approach to guide treatment decisions in the real world is needed.

• Controversy 4: Many studies which inform the guidelines are poorly designed and analyzed.

• Challenge 4: There is an urgent need for good-quality studies in AR, both RCT and observational. Data from these studies should be analyzed and interpreted in a way which makes sense to physicians and patients and also to guideline committee members.

• Controversy 5: AR control remains the aim of current management guidelines, yet currently a control concept and control language are lacking in AR.

• Challenge 5: A simple visual analog scale has been advocated by Contre les MAladies Chronique pour un VIeillissement Actif Allergic Rhinitis and its Impact on Asthma as the new language of AR control and the control cut-offs have been defined. This visual analog scale will be incorporated into the new AR management guideline called the AR integrated care pathway.

Notes