• First pooled analysis of Olopatadine/Mometasone FDC. • Reinforces significant improvements compared to mometasone and olopatadine. • Compiled safety data demonstrate low AEs and high adherence to treatment. This study was conducted to analyze the efficacy and safety of a fixed-dose combination of olopatadine HCl (antihistamine) and mometasone furoate (corticosteroid) (Olo/Mom, GSP301) for the treatment of Seasonal Allergic Rhinitis (SAR). Efficacy data from one phase II (NCT02318303 GSP301-201) and two pivotal phase III double-blind, randomized, active, placebo-controlled (NCT02631551 GSP301-301 and NCT02870205 GSP301-304) clinical trials were collated and analyzed. These studies investigated Olo/Mom (administered twice daily/BID) compared with placebo and its monotherapy constituents for the treatment of SAR in patients aged ≥12-years. In addition, safety data were analyzed from the aforementioned studies and a proof-of-concept study (NCT03444506 GSP301-POC). Primary and secondary endpoints were compared between Olo/Mom, its active mometasone and olopatadine constituents, and placebo. For the efficacy analyses (n = 2971), Olo/Mom significantly reduced rTNSS scores compared with placebo (Least Square Mean Difference LSMD = −0.94; 95% CI: −1.17, −0.70; p < 0.0001), olopatadine (LSMD = −0.37; 95% CI: −0.60, −0.14; p = 0.0019), and mometasone (LSMD = −0.42; 95% CI: −0.65, −0.18; p = 0.0005). Olo/Mom also significantly improved the RQLQ and iTNSS scores compared with placebo and its monotherapy constituents (p < 0.05, all). The onset of action of Olo/Mom was observed at 15-minutes and was sustained at subsequent timepoints. The incidence of treatment-emergent adverse events in the Olo/Mom, placebo, olopatadine, and mometasone groups was 13.9%, 9.5%, 13.2%, and 7.9%, respectively. This pooled analysis demonstrated the superiority of Olo/Mom compared to its monotherapy constituents or placebo in reducing SAR symptoms over 14-days. Moreover, this study showed that Olo/Mom has a rapid onset of action and significantly improves RQLQ scores compared to placebo. Administration of Olo/Mom BID is an effective and well-tolerated option for the treatment of SAR in patients aged 12-years or older. I (Level I – randomized controlled trials).
Nakanishi et al. (Tue,) studied this question.