A Clinical Study to Assess Efficacy and Safety of Etoricoxib 90 mg in Korean Patients with Rheumatoid Arthritis

Sung, Yoon Kyoung; Koh, Eun Mi; Park, Won; Lee, Soo Kon; Lee, Jisoo; Kim, Chul Joon; Park, Young Joo; Bae, Sang Cheol

Abstract

OBJECTIVE
To assess the efficacy and the safety of etoricoxib 90 mg daily administered to Korean patients for the treatment of rheumatoid arthritis over a 12-week period.
METHODS
Eighty-nine patients diagnosed with rheumatoid arthritis were administered Etoricoxib 90 mg for 12 weeks. Tender Joint Count (total 68 joints), Swollen Joint Count (total 66 joints), Patient Global Assessment of Disease Activity, and Investigator Global Assessment of Disease Activity were assessed as primary endpoints. Patient Global Assessment of Pain, Health Assessment of Questionnaire (HAQ: disability scales), Patient Global Assessment of Response to Therapy, Investigator Global Assessment of Response to Therapy, and Duration of Morning Stiffness were assessed as secondary endpoints. Those endpoints were assessed at week 2, 4, 8, and 12. Safety was evaluated by physical examination, serum chemistry, blood count, urinalysis, and occurrence of adverse events.
RESULTS
Etoricoxib 90 mg showed significant effects compared to baseline, thus the result indicated etoricoxib was clinically effective. Etoricoxib 90 mg showed significant improvement in all efficacy endpoints (primary endpoints and secondary endpoints). Treatment effects for etoricoxib 90 mg were approximately a 7.3 (95% CI 5.8 8.9, p<0.0001) joint reduction in the number of tender joints, 4.8 (95% CI 3.6 6.0, p<0.0001) joint reduction in the number of swollen joints, a 15.4 (95% CI 12.1 18.7, p<0.0001) mm improvement in the patient global assessment (100 mm VAS) and 1.3 (95% CI 1.1 1.6, p<0.0001) unit improvement in the investigator global assessment (0 to 4 Likert scale). Treatment effects were observed at the earliest time point of measurement and were maintained over time during the 12-week period. Drug-related clinical adverse events were reported by 22 (24.7%) of 89 safety evaluable subjects. Eight patients discontinued the drug due to clinical adverse events. Frequency of drug-related laboratory abnormalities was low with 2 (2.2%). Nobody discontinued due to laboratory abnormalities.
CONCLUSION
(1) Etoricoxib 90 mg once daily was clinically effective for the treatment of rheumatoid arthritis in Korea patients. (2) Etoricoxib 90 mg once daily administered to patients with rheumatoid arthritis was generally safe and well tolerated.