(HealthDay News) – An immunologically-enhanced subcutaneous immunotherapy (SCIT) formulation, with an optimized ratio of allergen to adjuvant, induces a significant immunologic response with acceptable safety when injected every three to four days compared with standard weekly injections.
Oliver Pfaar, MD, of the University Hospital in Mannheim, Germany, and colleagues conducted a randomized, controlled, parallel-group trial involving 400 patients with grass pollen-induced rhinoconjunctivitis, with or without asthma, to evaluate the efficacy and safety of a fast-updosed, immunologically-enhanced SCIT formulation. Group 1 (201 participants) received five subcutaneous doses of 300; 600; 3,000; 6,000; and 15,000 SQ+ given weekly, while group 2 (199 participants) received injections every three to four days. Both groups then received two maintenance injections of 15,000 SQ+ each.
From baseline to the end of the trial, the researchers found that both groups achieved statistically significant immunological responses, as shown by increased immunoglobulin (Ig)E-blocking factor, IgG4, and IgE. Local injection site reactions were the most commonly reported adverse events, reported in 30% of Group 1 and 41% of Group 2. Systemic reactions, including mild-to-moderate allergic rhinitis and urticaria, occurred in 21% of Group 1 and 33% of Group 2.
“Fast-updosed immunologically-enhanced SCIT with an optimized allergen/adjuvant ratio induced significant immunological effects and had an acceptable safety profile,” the authors conclude. “Clinical efficacy will be investigated in future clinical trials.”
Several authors disclosed financial ties to pharmaceutical companies, including ALK, which sponsored the study and manufactures the enhanced SCIT formulation.