Effectiveness and Response Predictors of Omalizumab in Treating Patients with Seasonal Allergic Rhinitis: A Real-World Study

Abstract

Background

Omalizumab has been proven effective and safety in treating seasonal allergic rhinitis (SAR) by several randomized clinical trials in many countries. However, there is lack of clinical reports of Chinese patients with SAR treated by omalizumab.

Objective

In the present real-world-designed study, we aimed to investigate the effectiveness of omalizumab in treating patients with SAR.

Methods

SAR patients administered omalizumab in various dosages were recruited, and follow-up was done. Their quality of life (QOL) and symptoms were assessed by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Total Nasal Symptoms Score (TNSS), Asthma Control Test (ACT), and clinical outcomes were compared between post- and pre-treatment conditions.

Results

Sixty SAR patients received omalizumab therapy in the study (mean age 35.47±17.02 years, 35 females). Omalizumab treatment significantly improved the quality of life (change in RQLQ overall score: −2.08±1.01, paired t-test p<0.001) and nasal symptoms (change in TNSS: −7.33±2.50, paired t-test p<0.001) of SAR patients. In 21 patients with co-existing asthma, the ACT score significantly increased from 16.10 to 22.57 on average (paired t-test p<0.001), indicating better-controlled asthma. Using a threshold of ≥1 point improvement in RQLQ overall score, 83.3% of patients responded to omalizumab. The responder group had a higher baseline RQLQ score and TNSS (p<0.05), but both responders and non-responders had comparable scores after treatment. Multiple linear regression analysis identified the baseline RQLQ overall score as a predictor of change in the RQLQ score in omalizumab-treated SAR.

Conclusion

Omalizumab is effective and safe in SAR treatment in a real-world setting.

Keywords:

• omalizumab
• seasonal allergic rhinitis
• nasal symptoms score
• quality of life
• real world

Abbreviations

SAR, seasonal allergic rhinitis; QOL, quality of life; RQLQ, Rhinoconjunctivitis Quality of Life Questionnaire; TNSS, Total Nasal Symptoms Score; ACT, Asthma Control Test.

Author Contributions

All authors made substantial contributions to conception and design, acquisition of data, analysis and interpretation of data; took part in drafting the article and revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval of the version to be published; and agree to be accountable for all aspects of the work.

Disclosure

All authors declare no conflicts of interest.

Additional information

Funding

This work was supported by the National Key Specialty Funding of China granted to XW, Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding Support (No. ZYLX201826), Open Research Funding of Beijing Key Laboratory of Bio-characteristic Profiling for Evaluation of Rational Drug Use (No. 2019-KF11) and Science and Technology Research and Development Project of China National Railway Group Co. (No. J2019Z603) granted to TM.