Evaluation of a Compliance Device in a Subgroup of Adult Patients Receiving Specific Immunotherapy With Grass Allergen Tablets (GRAZAX®) in a Randomized, Open-Label, Controlled Study: An A Priori Subgroup Analysis

Abstract Objectives: This a priori subgroup analysis was conducted to assess patients' experience with a compliance device for the administration of sublingual specific immunotherapy for grass pollen-induced rhinoconjunctivitis. Methods: The present paper reports the results of a subgroup analysis of a multicenter, randomized, controlled, open-label European study in which adults with grass pollen-induced rhinoconjunctivitis received once-daily treatment with grass allergen tablets with or without a device to aid compliance. Treatment was given ~6 to 12 weeks before the grass pollen season, during the season (~8–10 weeks), and for up to 2 weeks after the end of the season. In the subgroup analysis, patients from Germany and the Netherlands who had been randomized to receive the compliance device were asked to complete a brief questionnaire at the final study visit. The questionnaire included 6 items concerning patients' use of the device and whether it helped them remember to take their tablets. Results: Of the 91 patients from Germany and the Netherlands who were randomized to use the compliance device along with grass allergen tablets, 71 returned the questionnaire. Among responders, 58 of 71 (82%) reported using the device sometimes or always, 50 of 63 (79%) found the device easy to use, 32 of 69 (46%) found that the device made it easier to remember to take tablets, and 43 of 71 (61%) indicated that they would consider using the device again. Conclusion: Most patients in this subgroup analysis used the compliance device as a medication reminder and rated it easy to use.