Long-Term Treatment with Bilastine is Safe and Effective in Japanese Patients with Allergic Rhinitis

25 Nov, 21

Introduction

Results of a randomized phase 3 study demonstrated that bilastine 20 mg once daily for 2 weeks was well tolerated and effective in Japanese patients with perennial allergic rhinitis (PAR). Bilastine is a novel second generation antihistamine with a rapid onset of action. Long term safety data on bilastine 20 mg/day for 1 year has been obtained in an overseas clinical trial. However, long-term efficacy and safety of bilastine in Japanese patients with PAR and seasonal AR (SAR) is yet to be determined.

Aim

Long-term safety and efficacy of treatment with bilastine 20 mg/day for 12 weeks and 52 weeks in Japanese patients with SAR or PAR was evaluated.

Methods

Study Design

Open-label, single-arm, phase III study

Patient Profile

Inclusion criteria for SAR
- Age 18 to 74 years with at least 2-year history of Japanese Cedar (JC) pollinosis
- Positive for specific immunoglobulin E (IgE) antibodies to both JC and cypress allergens
- Total nasal symptom score (TNSS) >24 points
- Sum of rhinorrhea or sneezing scores >6 for 3 days before enrollment
Inclusion criteria for PAR
- Age between 18-74 years with at least 2-year history of PAR
- Positive for specific IgE antibodies to PAR allergens
- TNSS >16 points
- Sum of rhinorrhea or sneezing scores >5 for 3 days before enrollment
Exclusion Criteria
- Had active infections
- Had undergone specific immunotherapy or non-specific modulation therapy in the previous 3 years
- Received corticosteroids of anti-IgE antibody treatment in previous 180 days
- Patients with PAR were excluded if they had a nasal congestion score of 4 on atleast 1 of the 3 days prior to registration, a daily TNSS variation above 3 during observation period

Treatment Strategy

The eligible patients with SAR or PAR received bilastine 20mg, once daily in the morning for 12 weeks (treatment period).
Patients with PAR who met the transition criteria could continue the bilastine treatment for an additional 40 weeks (continuous treatment period: a total of 52 weeks).
The patients underwent clinical assessment for the symptoms at baseline.
Safety and efficacy were then assessed in this cohort.

Endpoints

Primary Endpoints

Adverse events (AEs)
Adverse drug reactions (ADRs)

Secondary Endpoints

Changes in TNSS from baseline
Total ocular symptom score (TOSS)
Total symptom score (TSS)

Quality-of-life (QoL) score

Results

A total of 58 patients with SAR and 64 patients with PAR were registered for the study.
Fifty-six patients (96.6%) with SAR completed the treatment period.
Fifty-five patients with PAR transitioned to the continuous treatment period (85.9%).
The incidence of AEs over the 12 weeks was 17.2% vs 31.3% of patients with SAR and PAR respectively
All the AEs were mild or moderate in the SAR patients.
ADRs were reported by 6.3% and none in the PAR and SAR groups respectively during the 12-week treatment period.
All of the ADRs were mild in severity.
AEs and ADRs were reported by 73.4% and 6.3% of patients with PAR, respectively in the 52-week treatment period.
The incidence of AEs and ADRs did not increase in duration-dependent manner.
The System Organ Class of nervous system disorders was used to categorize the AEs; headache was reported by 4.7%, but none reported somnolence.
There were no patient withdrawals or deaths due to drug-related AEs.
Treatment with bilastine resulted in significant reductions in TNSS, TOSS, and TSS as compared to baseline in patients with SAR.
The improvement in all the efficacy variables was sustained throughout the 52-week treatment period in patients with PAR.
Both the groups reported improvement in the QoL scores.

Conclusion

Long-term treatment with bilastine was found to be effective, safe and well tolerated in Japanese patients with seasonal and perennial allergic rhinitis.
The significant improvement in the symptoms was maintained for the duration of the study, with no loss of drug efficacy.

Auris Nasus Larynx. 2017 Jun;44(3):294-301. Doi: 10.1016/j.anl.2016.07.021.