Comments on Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines

CORRESPONDENCE 1641

J ALLERGY CLIN IMMUNOL VOLUME 127, NUMBER 6

In the United States, we support the approach recommended by the US Rhinitis Practice Parameters, which recommends NAH as first-line therapy.2 It is our unanimous clinical experience that these medications are useful as a primary therapy. Bradley Chipps, MDa Sheldon Spector, MDb Judith Farrar, PhDc Warner Carr, MDd Eli Meltzer, MDe William Storms, MDf Michael Kaliner, MDg Allan Luskin, MDh Donald Bukstein, MDi John Oppenheimer, MDj Brian Smart, MDk Jenifer Derebery, MDl Julia Harder, PharmDa Mark Dykewicz, MDm Michael Benninger, MDn From athe Capital Allergy and Respiratory Disease Center, Sacramento, Calif; bthe California Allergy and Asthma Medical Group, Los Angeles, Calif; cthe Life Sciences Press, Washington, DC; dthe Allergy and Asthma Associates of Southern California, Mission Viejo, Calif; ethe Allergy and Asthma Medical Group and Research Center, San Diego, Calif; fthe William Storms Allergy Clinic, Colorado Springs, Colo; gthe Institute for Asthma and Allergy, Chevy Chase, Md; hthe Department of Medicine, University of Wisconsin, Madison, Wis; ithe Dean Clinic, Madison, Wis; jPulmonary and Allergy Associates, Summit, NJ; kthe DuPage Medical Group, Glen Ellyn, Ill; lthe House Ear Clinic, Inc, Los Angeles, Calif; mthe Wake Forest University School of Medicine, Center for Human Genomics and Personalized Medicine Research, Winston-Salem, NC; and nthe Head and Neck Institute, The Cleveland Clinic, Ohio. E-mail: [email protected]. Disclosure of potential conflict of interest: B. Chipps receives research support from Genentech, AstraZeneca, GlaxoSmithKline, Novartis, Sunovion, and Merck-Schering; receives grants for educational activities from Alcon, Genentech, AstraZeneca, GlaxoSmithKline, and Novartis; has consultant arrangements with Alcon, Genentech, AstraZeneca, GlaxoSmithKline, Meda, Novartis, Sunovion, Merck-Schering, ISTA, Quintiles, and Dey; and is on the speakers’ bureau for Alcon, Genentech, AstraZeneca, GlaxoSmithKline, Meda, Novartis, Sunovion, Merck-Schering, ISTA, and Dey. W. Carr has consultant arrangements with MEDA, Alcon, and ISTA; receives research support from MEDA, Alcon, and ISTA; and serves on committees for the AAAAI and the ACAAI. E. Meltzer has consultant arrangements with and/or is on the advisory board for AdelphiEden, Amgen, Boehringer Ingelheim, Dey, Greer, ISTA, Johnson & Johnson, Meda, National Jewish Health, ONO Pharma, Rady Children’s Hospital San Diego, Sandoz, Stallergenes, Teva, Alcon, Kalypsys, Merck, Schering-Plough, and Sepracor; is on the speakers’ bureau for Alcon, GlaxoSmithKline, Merck, National Jewish Health, Nycomed, Sanofi-Aventis, Schering-Plough, and Sepracor; receives research support from Alexza, MAP, MedImmune, Alcon, Amgen, Astellas, Boehringer Ingelheim, Dey, Greer, ISTA, Johnson & Johnson, MEDA, Merck, Novartis, Sepracor, and Teva; has provided expert witness testimony in a case related to fexofenadine; is a fellow of the AAAAI and the ACAAI; and is a member of the World Health Organization. W. Storms receives research support from Alcon Labs, Amgen, Genentech, Meda, Merck, Novartis, Sunovion, and TEVA; has consultant arrangements with Alcon Labs, AstraZeneca, Genentech, Meda, Merck, Novartis, Sunovion, Strategic Pharmaceutical Advisors, TEVA, and the TREAT Foundation; and has served on speakers’ bureau for Alcon Labs, Genentech, Meda, Merck, Novartis, Sunovion, and TEVA. M. Kaliner has consultant arrangements with Alcon and Strategic Pharmaceutical Advisors; is on the speakers’ bureau for Meda and Ista Pharmaceuticals; has received research support from Schering-Merck, Alcon, and Meda; has provided legal consultation/expert witness testimony in cases related to nasal corticosteroids; and serves as historian for the World Allergy Organization. A. Luskin is on the advisory board for Merck, Genentech, Sunovium, and Ista and has consultant arrangements with Merck, Genentech, TEVA, Sunovium, and Ista. D. Burkstein is on the speakers’ bureau for Merck, AstraZeneca, Novartis, Meda, and Alcon and receives research support from Novartis and GlaxoSmithKline. J. Oppenheimer has consultant arrangements with AstraZeneca, GlaxoSmithKline, and Merck; receives research support from Novartis, Merck, and GlaxoSmithKline; and has provided legal consultation/expert witness testimony in cases related to medical malpractice defense. B. Smart is on the speakers’ bureau for AstraZeneca and GlaxoSmithKline and is a speaker/officer for the AAAAI. J. Derebery is on the advisory board for Meda Pharmaceuticals, Alcon Laboratories, Merck, Sonitus Hearing

Aid Research, and Strategic Pharmaceutical Advisors; is on the speakers’ bureau for Meda, Alcon, and Merck; receives research support from the Coulter Foundation, Otonomy Inc, Sonitus Inc, Alcon, and Phonak/Sonova; has provided legal consultation/expert witness testimony in cases related to Allergy Immunotherapy; and is on the board of directors for Epic Hearing Healthcare and Sonitus Hearing Aid Research. M. Dykewicz receives travel support from Merck and is vice chair of the RhinitisSinusitis Committee for the American College of Allergy, Asthma, and Immunology. M. Benninger has consultant arrangements with Alcon and Merck. The rest of the authors have declared that they have no conflict of interest.

REFERENCES 1. Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol 2010;126:466-76. 2. Wallace DV, Dykewicz MS, Bernstein DI, Blessing-Moore J, Cox L, Khan DA, et al. The diagnosis and management of rhinitis: an updated practice parameter. J Allergy Clin Immunol 2008;122:S1-84. 3. Benninger M, Farrar JR, Blaiss M, Chipps B, Ferguson B, Krouse J, et al. Evaluating approved medications to treat allergic rhinitis in the United States: an evidencebased review of efficacy for nasal symptoms by class. Ann Allergy Asthma Immunol 2010;104:13-9. 4. Chipps BE, Harder JM. Antihistamine treatment for allergic rhinitis: different routes, different outcomes? Allergy Asthma Proc 2009;30:589-94. 5. Kaliner MA. A novel and effective approach to treating rhinitis with nasal antihistamines. Ann Allergy Asthma Immunol 2007;99:383-91. 6. Lee T, Pickard S. Meta-analysis of azelastine nasal spray for the treatment of allergic rhinitis. Pharmacotherapy 2007;27:852-9. 7. Portnoy JM, Van Osdol T, Williams PB. Evidence-based strategies for treatment of allergic rhinitis. Curr Allergy Asthma Rep 2004;4:439-46. 8. Van Hoecke H, Vandenbulcke L, Can Cauwenberge P. Histamine and leukotriene receptor antagonism in the treatment of allergic rhinitis: an update. Drugs 2007;67: 2717-26. Available online April 9, 2011. doi:10.1016/j.jaci.2011.01.070

Comments on Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines To the Editor: The Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines are widely used for guidance regarding the treatment of allergic rhinitis.1 It is important to recognize the differences between ARIA, developed by a predominantly European committee, and the Practice Parameters on Rhinitis developed in the United States.2 The Joint Task Force on Practice Parameters in The Diagnosis and Management of Rhinitis: An Updated Practice Parameter recommends in some respects a significantly different approach to the management of rhinitis compared with that recommended in ARIA. ARIA recommends approaches to treatment not approved in the United States, such as sublingual immunotherapy, which is widely used in Europe. The Practice Parameters on Rhinitis could not appropriately recommend a therapeutic modality that has not been approved in this country. Another difference is that the Practice Parameters on Rhinitis look more favorably on the use of intranasal antihistamines and oral leukotriene antagonists in the management of allergic rhinitis, which is more consistent with current practice in the United States. Although, in developing the Practice Parameters on Rhinitis, the Joint Task Force on Practice Parameters has considered worldwide evidence on the diagnosis and management of rhinitis, it is important to remember that these parameters are developed for patient care in the United States. These evidence-based parameters are based on an extensive review of the literature using search tools such as PubMed. The

1642 CORRESPONDENCE

evidence was graded by using a method described in the British Medical Journal.3 Use of different grading systems can lead to different recommendations by equally competent groups of experts on the management of a specific condition. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessment tool used in ARIA produced different evidence ratings than those based on the evidence grading system used in the Practice Parameters on Rhinitis. In addition, the experts who developed ARIA have reached different conclusions about the data in the literature than the experts who developed the Practice Parameters on Rhinitis. It is well recognized that groups of experts can reach very different conclusions about such data. Even an evidence-based document is subject to individual differences of opinion. Defining the practice of medicine on the basis of individual patient differences is by its nature imperfect. After review of the available medical literature, therefore, different groups of experts should not be expected to reach identical conclusions about all aspects of the treatment of rhinitis, reinforcing the need for further research. The practicing physician should always be the final judge in regard to the best way to treat a particular patient. ARIA includes the importance of cost in the treatment of patients. However, with widespread and different insurance coverage in this country, cost may not always equate with the best treatment of patients. Furthermore, both patient preference and cost can be greatly influenced by the physician and health care system and shaped by the media and the patient’s social environment. Approaches to presenting the data that support a recommendation can also vary. Those who are developing practice parameters for allergists/immunologists in the United States believe that the practicing physician can best follow the logic of a recommendation if the key statements on an issue (summary statements) are followed by explanatory text that supports these summary statements, immediately followed by the references that support the text. With an accepted grading system, the data cited in the references can be graded, which then allows a grading of the strength of the evidence in the summary statements. It is also important to consider the review process through which these 2 documents have proceeded to publication. The practice parameters developed in this country undergo a rigorous review process beginning with their development by a work group of experts in that particular area. This is followed by intense interaction and review with the Joint Task Force. The document then goes to the leaders of the American Academy of Allergy, Asthma & Immunology (AAAAI) and the American College of Allergy, Asthma & Immunology (ACAAI), who select reviewers with expertise in that area to evaluate the document and make recommendations. At the same time, the document is placed online for review and comments by the entire membership of these organizations. The comments by the selected reviewers in the AAAAI and ACAAI and comments from the membership are then reviewed by the Joint Task Force and the work group that developed the parameter initially. When the document is sent for publication, there may be additional review requested by the journal to which it has been sent. The ARIA guidelines provide important considerations for the treatment of patients with rhinitis and should be read carefully by those who treat patients with rhinitis. It is equally important to recognize the degree to which they may be inconsistent with the

J ALLERGY CLIN IMMUNOL JUNE 2011

management of rhinitis in the United States. In this regard, the Practice Parameters on Rhinitis developed by the Joint Task Force on Practice Parameters with the support and guidance of the AAAAI and the ACAAI, after intensive review, provide a more relevant approach to the treatment of patients with this condition in the United States. Sheldon Spector, MD Dana Wallace, MD Richard Nicklas, MD, Co-Chair Jay Portnoy, MD, Co-Chair Joann Blessing-Moore, MD David Bernstein, MD Linda Cox, MD John Oppenheimer, MD David Lang, MD Diane Schuller, MD Christopher Randolph, MD Stephen Tilles, MD David Khan, MD In cooperation with Mark Dykewicz, MD From the Joint Task Force on Practice Parameters for Allergy and Immunology, sponsored by the American Academy of Allergy, Asthma & Immunology; the American College of Allergy, Asthma & Immunology; and the Joint Council of Allergy, Asthma & Immunology. E-mail: [email protected]. Disclosure of potential conflict of interest: S. Spector has consultant arrangements and is a speaker for AstraZeneca; receives research support and is a speaker for Novartis; receives research support from GlaxoSmithKline, TKL Perrigo, Amgen, AstraZeneca, Schering-Plough, GlaxoSmithKline, Genentech/Novartis, Boehringer Ingelheim, KarmelSonix, Merck, Medpoint, and Sunovion; has provided expert witness testimony in cases related to mold allergy; is on a committee for ACAAI; and is a speaker/moderator for the AAAAI. R. Nicklas is a committee chair for the ACAAI. J. Blessing-Moore is on the speakers’ bureau for AstraZeneca, Merck, Novartis, Genentech, and Alcon; receives research support from Merck, Genentech, and Novartis; is on the editorial board for the Task Force for Allergy Parameters; and is on committees for the AAAAI, the ACAAI, the ATS, and the ACCP. L. Cox has consultant arrangements with Stallergenes, receives research support from Stallergenes, and is on the board of directors for the AAAAI and the ABAI Joint Task Force. D. Lang is a speaker for GlaxoSmithKline; has served as a speaker and/or consultant for Merck, AstraZeneca, Teva, Sanofi Aventis, Genentech, and Novartis; and receives research support from Genentech/Novartis. D. Wallace has provided legal consultation/expert witness testimony on skin conditions in workers’ compensation cases and is president of the ACAAI. J. Portnoy is on the board for ACAAI and receives honoraria from Merck, Phadia, and UCB India. J. Oppenheimer has consultant arrangements with AstraZeneca, GlaxoSmithKline, and Merck; receives research support from Novartis, Merck, and GlaxoSmithKline; and has provided legal consultation/expert witness testimony in cases related to medical malpractice defense. D. Schuller is past president of the ACAAI and is secretary-treasurer of the PA Allergy Society. S. Tilles is on the speakers’ bureau for Alcon and ISTA; has consultant arrangements with Merck; receives research support from Alcon, Amgen, Amphastar, Astellas, Boehringer Ingelheim, Ception, Genentech, Icagen, Merck, Novartis, Sepracor, and Aventis; is employed part time as executive director of Asthma, Inc; is a member of the ACAAI; and serves as associate editor for Annals of Allergy and Allergy Watch. D. Khan is a speaker for AstraZeneca, Merck, and Genentech; receives research support from the Vanberg Family Foundation and the Sellars Family Foundation; is the Conjoint Board Review Chair for ACAAI; and is past president of TAAIS. M. Dykewicz has received travel support from Merck and is vice chair of the Rhinitis Sinusitis Committee for the ACAAI. The rest of the authors have declared that they have no conflict of interest.

REFERENCES 1. Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol 2010;126:466-76. 2. Wallace DV, Dykewicz MS, Bernstein DI, Blessing-Moore J, Cox L, Khan DA, et al. The diagnosis and management of rhinitis; an updated practice parameter. J Allergy Clin Immunol 2008;122:S1-84. 3. Shekelle PG, Woolf SH, Eccles M, Grimshaw J. Clinical guidelines: developing guidelines. BMJ 1999;318:593-6. Available online April 15, 2011. doi:10.1016/j.jaci.2011.01.071