Development of sublingual immunotherapy and anti-IgE therapy for allergic rhinitis in Japan

Abstract

Sublingual immunotherapy (SLIT) was first reported for perennial allergic rhinitis by Scadding in 1986. We conducted the SLIT open study in cedar pollinosis between 2000 and 2003 with the approval of the Ethics Committee of Nippon Medical School. In 2004, a double-blind comparative study on SLIT for cedar pollinosis was conducted by the Ministry of Health, Labour and Welfare (MHLW) as part of the Immunology Research Project funded by the Grant-in-Aid for Scientific Research on Immunological Diseases (Grant-in-Aid for Scientific Research on Immunology). In 2005, we reported that SLIT was effective against cedar pollinosis during heavy cedar pollen dispersal. The efficacy of SLIT for cedar pollinosis, which has already become a common treatment, is clear. We also reported the post-effect of SLIT on actual drugs after 3 years of SLIT in tablet form in a double-blind, controlled study; we found differences in IgE and IgG4. Further studies on the production of these antibodies are required.

In 1991, a humanized monoclonal antibody rhuMAbE25 (omalizumab) was developed, which has specificity for Cε3, the receptor to which human IgE binds to Fcε receptor I. It is currently indicated worldwide for severe bronchial asthma and severe urticaria. Clinical trials on omalizumab for cedar pollinosis began in 2002. In 2018, a clinical trial was conducted for severe cedar pollinosis resistant to existing therapies. The antihistamine and nasal spray steroid significantly improved nasal and ocular symptom scores over placebo in patients with severe cedar pollinosis who remained symptomatic, leading the world to obtain a 2019 indication for omalizumab for severe hay fever. We will continue researching so that drug development can provide a new treatment method in general clinical practice.