Benefits of Combining Olopatadine and Mometasone in the Treatment of Allergic Rhinitis
Ryaltris is indicated for adults and adolescents aged 12 years and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis (AR). The active ingredient of the preparation is a fixed combination of locally acting antihistamine olopatadine hydrochloride and corticosteroid mometasone furoate. Its efficacy and safety have been confirmed by numerous clinical studies, compared to placebo, as well as other drugs used in the treatment of AR.
COMMERCIAL MESSAGE
Synergistic Treatment of Allergic Rhinitis
Ryaltris is a nasal spray indicated for the treatment of nasal symptoms of moderate to severe allergic rhinitis in adults and children aged 12 years and older, containing two active substances with different mechanisms of action that show a synergistic effect in improving AR symptoms.
The first substance is olopatadine hydrochloride, a potent selective antihistamine that affects the development of an allergic reaction in a complex manner. Olopatadine is a histamine antagonist, the primary mediator of allergic reactions in humans, and also has anti-inflammatory and mast cell-stabilizing effects.
The second active substance is the locally acting glucocorticoid mometasone furoate, with primarily anti-inflammatory properties. A large part of mometasone's efficacy is probably due to its ability to inhibit the release of mediators of allergic reactions. Mometasone significantly inhibits the production and release of leukotrienes from leukocytes in allergic patients. In cell cultures, mometasone has been shown to be highly effective in inhibiting the synthesis and release of several pro-inflammatory substances, such as interleukins IL-1, IL-5, IL-6, tumor necrosis factor alpha (TNF-α) and leukotrienes. Mometasone is also an extremely effective inhibitor of the production of TH2 cytokines (IL-4 and IL-5) from human CD4+ T lymphocytes.
An important feature of olopatadine is its ability to affect eye symptoms of allergy within rhinoconjunctivitis, even when administered intranasally. This was demonstrated, for example, in a clinical study published by Hampel et al. The study involved 1,180 patients who were administered a combination of olopatadine and mometasone for 14 days. Besides a positive effect on nasal symptoms, a positive effect was also noted on the eye symptoms of allergic rhinoconjunctivitis.
Results of Direct Comparison
Although extensive studies comparing the efficacy of Ryaltris with potential comparators have not yet been conducted, an acceptable level of direct comparison data with high evidence is provided by the study published by Patel et al. The randomized double-blind double-dummy placebo-controlled clinical study conducted using an environmental exposure chamber (EEC) with ragweed pollen involved 180 adult patients aged 18-65 years suffering from seasonal allergic rhinitis.
The aim of the study was to evaluate the efficacy and safety of two different dosing regimens of Ryaltris (665 μg olopatadine and 50 μg mometasone once daily and 665 μg olopatadine and 25 μg mometasone twice daily) compared to placebo, a preparation containing 137 μg azelastine and 50 μg fluticasone administered twice daily, and a preparation containing 665 μg olopatadine administered twice daily. The total treatment period was 14 days, with the primary aim of the study being to evaluate the reduction in immediate total nasal symptom score (iTNSS). Other study aims included evaluating the reduction in immediate total ocular symptom score (iTOSS), the speed of onset of effect, and adverse effects of the treatment.
The study observed statistically and clinically significant improvement in iTNSS scores at the end of treatment compared to the baseline pre-treatment value with Ryaltris treatment, compared to placebo and olopatadine. A favoring difference was also observed compared to the preparation containing azelastine and fluticasone, which, however, did not reach statistical significance.
In the parameter of ocular symptoms evaluated by iTOSS score reduction, statistically significant improvement was observed for both dosing regimens compared with placebo. Statistically significant effects were observed when comparing to olopatadine dosing twice daily. When compared to the preparation containing azelastine and fluticasone, comparable improvement values were observed.
An important result of the study is the speed of onset of the effect of the preparation. For the twice-daily dosing regimen, a significant difference in iTNSS score was observed compared to placebo after just 10 minutes. The occurrence of adverse events was comparable in all groups, with most being mild to moderate, predominantly in the form of dysgeusia and headaches.
Conclusion
Ryaltris containing a fixed combination of antihistamine olopatadine and corticosteroid mometasone represents an effective and safe choice of local therapy for allergic rhinitis, compared to placebo and other modalities of local pharmacotherapy. An undeniable advantage of the preparation is also its effect on eye symptoms frequently observed in patients with AR as part of allergic rhinoconjunctivitis.
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Sources:
1. Hampel F. C., Pedinoff A. J., Jacobs R. L. et al. Olopatadine-mometasone combination nasal spray: evaluation of efficacy and safety in patients with seasonal allergic rhinitis. Allergy Asthma Proc 2019; 40 (4): 261–272, doi: 10.2500/aap.2019.40.4223.
2. Patel P., Salapatek A. M., Tantry S. K. Effect of olopatadine-mometasone combination nasal spray on seasonal allergic rhinitis symptoms in an environmental exposure chamber study. Ann Allergy Asthma Immunol 2019; 122 (2): 160–166.e1, doi: 10.1016/j.anai.2018.10.011.
3. SPC Ryaltris. Available at: www.sukl.cz/modules/medication/detail.php?code=0247020&tab=texts
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