Phase II double-blind, placebo-controlled trial shows significant, marked increase in allergen tolerance
TUESDAY, March 29, 2016 (HealthDay News) — Dermatophagoides pteronyssinus (DP) subcutaneous allergen immunotherapy (AIT) seems safe and effective for local allergic rhinitis (LAR), according to a study published online March 23 in Allergy.
Carmen Rondón, M.D., Ph.D., from the IBIMA-Regional University Hospital of Málaga in Spain, and colleagues conducted a first randomized, double-blind, placebo-controlled phase II trial of DP-AIT in 36 LAR patients. Participants were randomized to Pangramin Plus DP or placebo for 24 months. Symptoms, medication scores, and medication-free days were assessed as primary end points. Secondary end points included skin test, serum specific immunoglobulin E (sIgE) and IgG4, nasal allergen provocation test (NAPT), and adverse events.
The researchers observed significant improvements in primary and secondary end points for AIT-DP versus placebo. A significant and marked increase was seen in allergen tolerance after 12 months of AIT-DP, with negative NAPT in 50 percent of patients; significant increases were seen in serum sIgG4. Immunotherapy was well tolerated, with no reports of systemic reactions.
“This study demonstrated that AIT-DP is a safe and clinically effective treatment for LAR, confirming that LAR is a new indication for AIT,” the authors write.
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