A multicenter randomized study: safety of an optimized accelerated house dust mite immunotherapy for patients with allergic rhinitis in China (PERFECT study).
The one-strength injection regimen has increasingly become the mainstream paradigm for subcutaneous immunotherapy (SCIT). This study aimed to assess the safety and tolerability of an optimal accelerated scheme for SCIT using a house dust mite (HDM) product in adolescents and adults with allergic rhinitis (AR) or rhinoconjunctivitis (ARC), with or without asthma in China.
In this multicenter, open-label trial, patients were randomized to either One-strength or Standard group. The One-strength scheme included 6 injections with one-strength (5,000 TU/mL) followed by 4 injections at the maximum tolerated dose, administered without dose reduction when initiating a new vial. In contrast, the Standard regimen involved 14 injections across three strengths (50, 500 and 5,000 TU/mL), followed by 4 maintenance injections administered according to the medication instruction. Safety outcomes were determined by assessing Adverse Drug Reactions (ADRs), while tolerability was evaluated using a 5-point Likert scale.
Overall, 211 patients were randomized, with 108 assigned to the One-strength group, and 103 to the Standard group. Among all participants, 57.3% reported ADRs, of which 95.3% were local reactions. Systemic ADRs were observed in 7.4% of patients in the One-strength group and 8.7% in the Standard group, with no significant difference between the two groups (p=0.7233). All ADRs were classified as WAO grade 1 or 2, with no grade ≥3. In both adolescent and adult subgroups, the incidence of systemic ADRs remained comparable between the two arms (p > 0.05). However, in adults, only the incidence of local ADRs in the One-strength group was significantly higher than that in the Standard group (p=0.0004). Tolerability was rated as "good" or "very good" by approximately 84% of patients and investigators in the One-strength group and 70% of the Standard group (p=0.0131 for patient rating; p=0.0142 for investigator rating).
The One-strength scheme, consisting of 6 injections and no dose reduction when starting a new pack during the maintenance phase, is as safe and tolerable as standard SCIT regimen in adolescents and adults in China.
www.chictr.org.cn, identifier ChiCTR2200060194.
In this multicenter, open-label trial, patients were randomized to either One-strength or Standard group. The One-strength scheme included 6 injections with one-strength (5,000 TU/mL) followed by 4 injections at the maximum tolerated dose, administered without dose reduction when initiating a new vial. In contrast, the Standard regimen involved 14 injections across three strengths (50, 500 and 5,000 TU/mL), followed by 4 maintenance injections administered according to the medication instruction. Safety outcomes were determined by assessing Adverse Drug Reactions (ADRs), while tolerability was evaluated using a 5-point Likert scale.
Overall, 211 patients were randomized, with 108 assigned to the One-strength group, and 103 to the Standard group. Among all participants, 57.3% reported ADRs, of which 95.3% were local reactions. Systemic ADRs were observed in 7.4% of patients in the One-strength group and 8.7% in the Standard group, with no significant difference between the two groups (p=0.7233). All ADRs were classified as WAO grade 1 or 2, with no grade ≥3. In both adolescent and adult subgroups, the incidence of systemic ADRs remained comparable between the two arms (p > 0.05). However, in adults, only the incidence of local ADRs in the One-strength group was significantly higher than that in the Standard group (p=0.0004). Tolerability was rated as "good" or "very good" by approximately 84% of patients and investigators in the One-strength group and 70% of the Standard group (p=0.0131 for patient rating; p=0.0142 for investigator rating).
The One-strength scheme, consisting of 6 injections and no dose reduction when starting a new pack during the maintenance phase, is as safe and tolerable as standard SCIT regimen in adolescents and adults in China.
www.chictr.org.cn, identifier ChiCTR2200060194.
Authors
He He, Meng Meng, Yuan Yuan, Liu Liu, Fu Fu, Lai Lai, Xie Xie, Liu Liu, Zhang Zhang, Zhang Zhang, Wang Wang, Xie Xie, Jiang Jiang, Xie Xie
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