Projected 24-hour post-dose ocular itching scores post-treatment with olopatadine 0.7% versus 0.2.

Abstract

Olopatadine is an antihistamine and mast cell stabilizer used for treating allergic conjunctivitis. Olopatadine 0.7% has been recently approved for daily dosing in the US, which supersedes the previously approved 0.2% strength. The objective of this analysis was to characterize patients who have better itching relief at 24 h when taking olopatadine 0.7% treatment instead of olopatadine 0.2% (in terms of proportions of responses) and relate this to the severity of baseline itching as an indirect metric of a patient's sensitivity to antihistamines. A differential odds model was developed using data from two conjunctival allergen challenge (CAC) studies to characterize individual-level and population-level response to ocular itching following olopatadine treatment and the data was analyzed retrospectively. This modeling analysis was designed to predict 24 h ocular itching scores and to quantify the differences in 24 h itching relief following treatment with olopatadine 0.2% versus 0.7% in patients with moderate-to-high baseline itching. A one-compartment kinetic-pharmacodynamic Emax model was used to determine the effect of olopatadine. Impact of baseline itching severity, vehicle effect and the drug effect on the overall itching scores post-treatment were explicitly incorporated in the model. The model quantified trends observed in the clinical data with regards to both mean scores and the proportions of patients responding to olopatadine treatment. The model predicts a higher proportion of patients in the olopatadine 0.7% versus 0.2% group will experience relief within 24 h. This prediction was confirmed with retrospective clinical data analysis. The number of allergy patients relieved with olopatadine 0.7% increased with higher baseline itching severity scores, when compared to olopatadine 0.2%.

• Authors: Matthew L Fidler, Abayomi Ogundele, David Covert, Ramesh Sarangapani
• Journal: Journal of pharmacokinetics and pharmacodynamics (J Pharmacokinet Pharmacodyn) Vol. 45 Issue 4 Pg. 593-605 (08 2018) ISSN: 1573-8744 [Electronic] United States
• PMID: 29680872 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Allergens
• Histamine Antagonists
• Histamine H1 Antagonists
• Olopatadine Hydrochloride

Topics

• Adolescent
• Adult
• Aged
• Allergens (immunology)
• Conjunctivitis, Allergic (drug therapy, immunology)
• Double-Blind Method
• Female
• Histamine Antagonists (administration & dosage)
• Histamine H1 Antagonists (administration & dosage)
• Humans
• Male
• Middle Aged
• Olopatadine Hydrochloride (administration & dosage)
• Pruritus (drug therapy, immunology)
• Retrospective Studies
• Treatment Outcome
• Young Adult