Clinical Study On Subcutaneous And Sublingual Immunotherapy In Mite-sensitized Patients With Allergic Rhinitis

Objective This clinical study aimed to investigate the efficacy and safety profileof subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT) inpatients with allergic rhinitis (AR) caused by house dust mites. The treatmentcompliance and related factors were also evaluated.Methods A total of 160 patients with AR were enrolled in this study and receivedeither SCIT (Alutard SQ, ALK-Abelló) or SLIT (Chanllergen-Df drops, WolwoPharma). All subjects were divided into two groups: SCIT group consisted of 81patients aged 7 to 62 years (mean age, 21.5±14.6 years), and SLIT group consistedof 79 patients aged 6 to 53 years (mean age, 15.1±10.3 years). The selected patientswere persistent and moderate/severe AR sensitized to Dp and Df. Local and systemicreactions, as well as patient's adherence to the treatment, were carefully recorded andanalyzed during the immunotherapy schedules (followed up from 6 months to 2years). Nasal symptom scores and visual analogue scores (VAS) were collected, andserum total IgE, Dp and Df allergen-specific IgE and eosinophil cationic protein (ECP)levels were measured at baseline and 12 months after treatment.Results SCIT and SLIT demonstrated a significant reduction of nasal symptomscores, VAS and serum ECP levels (P<0.05) after 1 year's treatment. No significantchanges were observed for total serum total and specific IgE levels (P>0.05). Localswelling was commonly occurred following injections throughout the treatmentduration (62.9% of overall injections) in the SCIT group. Oral itching associated with drop intakes were reported by 4 subjects (5.1%) in the SLIT group. All local reactionswere mild, well tolerated and self-limiting both in two groups. A total of 11 patients(13.6%) with 18 injections (0.9%) experienced systemic reactions in the SCIT group,involving respiratory distress, asthmatic attacks, and urticaria. These adverse effectswere mostly immediate reactions, and occurred more frequently in patients during themaintenance phase of treatment. There were also 11 patients (13.9%) reportedsystemic reactions in the SLIT group, including gastrointestinal symptoms, urticaria,rhinitis exacerbations, and so on. However, systemic reactions to SLIT were mainlyobserved in patients during the up-dosing phase of treatment. No significantdifference in the overall incidence of systemic adverse effects was found between theSCIT and SLIT groups (13.6% vs 13.9%, P>0.05). There was only one case of nonlife-threatening systemic reaction (severe asthma) in the SCIT group. Others weremild or moderate and no anaphylactic shock occurred in any group. No significantdifference in treatment compliance was found between the SCIT and SLIT groups(86.4% vs 79.7%, P>0.05), with an overall rate of compliance (83.1%) among 160patients. The most common cause for treatment withdrawal was represented by aninsufficient effectiveness in both groups of SCIT (6.2%) and SLIT (10.1%).ConclusioConclusion Our results demonstrat an favorable clinical efficacy in mitesensitizedpatients with AR after 1 year's treatment with either SCIT or SLIT. It issuggested that the frequency of systemic adverse effects of SCIT is not significantlydifferent from SLIT in AR patients, and both treatments are well tolerated and have agood compliance during the study period.