Comparative Study of Cluster and Conventional Immunotherapy Schedules with <i>Dermatophagoides pteronyssinus</i> in the Treatment of Persistent Allergic Rhinitis

Abstract

Background and Objectives: Allergy to house dust mite is one of the most common causes of allergic rhinitis (AR) in China. We sought to compare the efficacy and safety of a 6-week cluster schedule of specific immunotherapy with that of a 14-week conventional schedule for the treatment of subjects with persistent AR. Methods: The trial was a prospective and randomized study involving 96 patients with persistent AR, aged 14–60 years, who were allergic to Dermatophagoides pteronyssinus. While 48 patients were randomly assigned to the cluster schedule reaching the maintenance dose within 6 weeks, the other 48 were randomly assigned to the conventional schedule reaching the maintenance dose within 14 weeks. Eighty-nine patients completed a 1-year treatment course. While kinetic changes in clinical efficacy and adverse reactions were observed during the treatment, quality of life, cutaneous reactivity and serum-specific immunoglobulin E to Dermatophagoides pteronyssinus were measured before and after treatment. Results: The cluster schedule reduced the time to reach the maintenance dose by 57% and caused mild systemic adverse reactions after 1.0% of injections (6.7% of patients), with no differences in comparison with the conventional schedule. Cluster specific immunotherapy led to decreases in clinical symptoms and earlier use of medication than did the conventional schedule. Similar improvements in quality of life and reduced cutaneous reactivity without significant changes in specific immunoglobulin E were observed in both groups after 1 year. Conclusions: The cluster schedule is a safe alternative to the conventional schedule with the advantage of achieving clinical effectiveness sooner.

Chinese Guideline on allergen immunotherapy for allergic rhinitis

“…J Thorac Dis 2017;9(11):4607-4650 jtd.amegroups.com no differences existed in the incidence of either local adverse reaction or systemic adverse reaction between the cluster group and control group (194). Although several studies suggest that cluster AIT is a safe routine clinical practice (195,196,202,203), Other studies have indicated that the adverse reactions range from 1% in patients receiving a conventional schedule, to 0-79% in patients receiving cluster SIT (26,203). Thus, from this point of view, the safety of cluster AIT needs to be further investigated and confirmed in other larger trials.…”

“…During the rush protocol, multiple injections are administered on consecutive days, and reach maintenance dose typically within one week. It has been shown that following a cluster schedule, there is a more rapid achievement of symptomatic improvement, with no increase in systemic reactions (SRs) (26,179). In contrast, a rush protocol is associated with an increase in SRs sometimes, however, these can generally be well tolerated (180,181).…”

“…The patients are observed for another 30 min after the last injection of each cluster. The maximum dose of 100,000 SQ is administered at the 6th or 8th week, and the dosing interval is then gradually increased to 6 weeks and maintained until the end of the first year (26). The total treatment schedule is around 3 years.…”

“…To ensure safety, PEF is recorded before and 1 h after the injections for each asthma patient (26). Patients are excluded from the schedule if treatment has been interrupted for longer than 5 weeks during the initial phase or longer than 16 weeks in the maintenance phase, or if severe adverse SRs occur.…”

“…Clusteror rush-specific subcutaneous immunotherapy (SCIT) schedules have been proven to be good alternatives in terms of their safety as well efficiency. It is worth mentioning that the cluster schedule reported by Zhang and colleagues (26) in 2009 as a safe alternative to the conventional schedule with the advantage of achieving clinical effectiveness sooner has subsequently been referenced in several international guidelines of immunotherapy for allergy (27,28). More recently, a prospective, open-IV clinical trial by Qiu and colleagues (29) has confirmed the safety and efficacy of rush immunotherapy (RIT) and conventional immunotherapy in Chinese AR patients.…”