Jennifer Maloney1, Gary Berman2, Remi Gagnon3, David I Bernstein4, Harold S Nelson5, Jörg Kleine-Tebbe6, Amarjot Kaur1, Qing Li1, Hendrik Nolte7. 1. Merck & Co., Inc, Kenilworth, NJ. 2. Clinical Research Institute, Inc, Minneapolis, Minn. 3. Clinique Spécialisée en Allergie de la Capitale, Québec, QC, Canada. 4. Bernstein Clinical Research Center and Division of Immunology and Allergy, University of Cincinnati, Cincinnati, Ohio. 5. National Jewish Health, Denver, Colo. 6. Allergy & Asthma Center Westend, Berlin, Germany. 7. Merck & Co., Inc, Kenilworth, NJ. Electronic address: hendrik.nolte@merck.com.
Abstract
BACKGROUND: Dual treatment with grass and ragweed sublingual immunotherapy (SLIT) tablets has not been studied. OBJECTIVE: To characterize the safety and tolerability of dual grass and ragweed SLIT-tablet administration. METHODS: This open-label, multicenter trial (NCT02256553) enrolled North American adults (N = 102) allergic to grass and ragweed. The trial had 3 periods, each of 2 weeks duration. In period 1, subjects received once-daily timothy grass SLIT tablet (2800 bioequivalent allergen unit; Merck, Inc, Kenilworth, NJ/ALK, Hørsholm, Denmark). In period 2, subjects received a short ragweed SLIT tablet (12 Ambrosia artemisiifolia 1-U; Merck/ALK) every morning and a grass SLIT tablet every evening. In period 3, subjects received once-daily grass and ragweed SLIT tablets within 5 minutes (simultaneous intake). The primary end point was the proportion of subjects with 1 or more local swelling events in each period. Secondary end points were the proportion of subjects with 1 or more local adverse events (AEs), that discontinued the treatment because of AEs, and subjects with 1 or more local AEs requiring treatment. RESULTS: No severe swellings, systemic allergic reactions, asthma attacks, or reactions requiring epinephrine were reported. Most (99%) AEs were graded mild to moderate. The proportions of subjects with 1 or more local swelling events were 14%, 22%, and 15% for periods 1, 2, and 3, respectively. For periods 1, 2, and 3, the proportions of subjects with 1 or more local AEs were 71%, 69%, and 56%, respectively; the proportions discontinuing the treatment because of treatment-related AEs were 5%, 1%, and 2%, and the proportions with 1 or more local AEs requiring treatment were 4%, 4%, and 1%. CONCLUSIONS: In this trial, a 4-week sequential SLIT-tablet dosing schedule followed by simultaneous intake of timothy grass and ragweed tablets was well tolerated.
BACKGROUND: Dual treatment with grass and ragweed sublingual immunotherapy (SLIT) tablets has not been studied. OBJECTIVE: To characterize the safety and tolerability of dual grass and ragweed SLIT-tablet administration. METHODS: This open-label, multicenter trial (NCT02256553) enrolled North American adults (N = 102) allergic to grass and ragweed. The trial had 3 periods, each of 2 weeks duration. In period 1, subjects received once-daily timothy grass SLIT tablet (2800 bioequivalent allergen unit; Merck, Inc, Kenilworth, NJ/ALK, Hørsholm, Denmark). In period 2, subjects received a short ragweed SLIT tablet (12 Ambrosia artemisiifolia 1-U; Merck/ALK) every morning and a grass SLIT tablet every evening. In period 3, subjects received once-daily grass and ragweed SLIT tablets within 5 minutes (simultaneous intake). The primary end point was the proportion of subjects with 1 or more local swelling events in each period. Secondary end points were the proportion of subjects with 1 or more local adverse events (AEs), that discontinued the treatment because of AEs, and subjects with 1 or more local AEs requiring treatment. RESULTS: No severe swellings, systemic allergic reactions, asthma attacks, or reactions requiring epinephrine were reported. Most (99%) AEs were graded mild to moderate. The proportions of subjects with 1 or more local swelling events were 14%, 22%, and 15% for periods 1, 2, and 3, respectively. For periods 1, 2, and 3, the proportions of subjects with 1 or more local AEs were 71%, 69%, and 56%, respectively; the proportions discontinuing the treatment because of treatment-related AEs were 5%, 1%, and 2%, and the proportions with 1 or more local AEs requiring treatment were 4%, 4%, and 1%. CONCLUSIONS: In this trial, a 4-week sequential SLIT-tablet dosing schedule followed by simultaneous intake of timothy grass and ragweed tablets was well tolerated.