SQ-standardized sublingual grass immunotherapy: Confirmation of disease modification 2 years after 3 years of treatment in a randomized trial - 01/03/12
, Waltraud Emminger, MD b, Alexander Kapp, MD, PhD c, Jan G.R. de Monchy, MD d, Sabina Rak, MD e, Glenis K. Scadding, MD, FRCP f, Peter A. Wurtzen, PhD g, Jens S. Andersen, PhD g, Bente Tholstrup, MSc g, Bente Riis, PhD g, Ronald Dahl, MD h
Corresponding author: Stephen R. Durham, MD, Section of Allergy and Clinical Immunology, National Heart and Lung Institute, Imperial College London, Guy Scadding Bldg, Royal Brompton Campus, Dovehouse St, SW3 6LY London, United Kingdom.Abstract |
Background |
The main aim of specific immunotherapy is sustained effect due to changes in the immune system that can be demonstrated only in long-term trials.
Objective |
To investigate sustained efficacy and disease modification in a 5-year double-blind, placebo-controlled trial, including 2 years of blinded follow-up after completion of a 3-year period of treatment, with the SQ-standardized grass allergy immunotherapy tablet, Grazax (Phleum pratense 75,000 SQ-T/2,800 BAU, ALK, Denmark) or placebo.
Methods |
A randomized, double-blind, placebo-controlled, multinational, phase III trial included adults with a history of moderate-to-severe grass pollen–induced allergic rhinoconjunctivitis, with or without asthma, inadequately controlled by symptomatic medications. Two hundred thirty-eight participants completed the trial. End points included rhinoconjunctivitis symptom and medication scores, combined scores, asthma symptom and medication scores, quality of life, days with severe symptoms, immunologic end points, and safety parameters.
Results |
The mean rhinoconjunctivitis daily symptom score was reduced by 25% to 36% (P ≤ .004) in the grass allergy immunotherapy tablet group compared with the placebo group over the 5 grass pollen seasons covered by the trial. The rhinoconjunctivitis DMS was reduced by 20% to 45% (P ≤ .022 for seasons 1-4; P = .114 for season 5), and the weighted rhinoconjunctivitis combined score was reduced by 27% to 41% (P ≤ .003) in favor of active treatment. The percentage of days with severe symptoms during the peak grass pollen exposure was in all seasons lower in the active group than in the placebo group, with relative differences of 49% to 63% (P ≤ .0001). Efficacy was supported by long-lasting significant effects on the allergen-specific antibody response. No safety issues were identified.
Conclusion |
The results confirm disease modification by SQ-standardized grass allergy immunotherapy tablet in addition to effective symptomatic treatment of allergic rhinoconjunctivitis.
Le texte complet de cet article est disponible en PDF.Key words : Allergy immunotherapy tablet, disease modification, grass pollen, immunotherapy, sublingual, sustained efficacy, placebo-controlled, Phleum pratense, rhinoconjunctivitis, rhinoconjunctivitis quality of life
Abbreviations used : AIT, DMS, DSS, RCS, SQ
Plan
| The trial was sponsored by ALK, Denmark. S.R.D. has received consultancy and lecture fees and grant support from ALK. A. Kapp has consultant arrangements with DPC; has received grant support from Novartis, Astellas, UCB, ALK, and DPC; and is on the speakers’ bureau for Novartis, Astellas, UCB, and ALK. J.G.R.d.M. has received a grant from ALK. S.R. has received grant support from the Swedish Asthma and Allergy Association. R.D. has been on advisory boards for Nycomed, Boehringer Ingelheim, Novartis, TEVA, Oxagen, and Vectura and has received grant support from GlaxoSmithKline, Boehringer Ingelheim, Novartis, AstraZeneca, ALK, Stallergenes, and Pfizer. G.K.S. has been on advisory boards and is on the speakers’ bureau for ALK and is advisor and speaker for Merck. P.A.W., J.S.A., B.T., and B.R. are employed by ALK. |
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| Disclosure of potential conflict of interest: S. R. Durham has received honoraria for lectures and consulting from ALK, Denmark, and Merck; has received research support from ALK, Denmark; and is head of the Allergy Consortium Immune Tolerance Network/National Institute of Allergy and Infectious Disease. W. Emminger, J. G. R. de Monchy, and G. K. Scadding have received research support from ALK. A. Kapp has provided consultation services for ALK. S. Rak has received consultation fees from AllergoPharma, lecture honoraria from Stallergenes, and research support from AllergoPharma and Allergenes, and has provided consultation services/expert witness testimony on the topic of sublingual immunotherapy. P. A. Wurtzen is a shareholder in ALK and a member of the Lundbeck Foundation Board of Directors. B. Tholstrup is a shareholder in ALK. B. Riis is a shareholder in ALK Abelló. R. Dahl has received lecture fees or is on the advisory board for Boehringer-Ingelheim, AstraZeneca, ALK, Airsonett, MSD, Novartis, Vectura, Elevation, Roche, and Norpharma; has received research support from ALK, Stalleren, Pfizer, Boehringer Ingelheim, AstraZeneca, Novartis, Airsonett, and GlaxoSmithKline; is Chairman of the Danish Respiratory Society; is Vice-chair of the Global Alliance against Chronic Respiratory Diseases; and is past president of Interasma. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 129 - N° 3
P. 717 - mars 2012 Retour au numéro
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