A Phase 2 Trial of Hydroxychloroquine in Individuals at Risk for Rheumatoid Arthritis.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Deane Kevin D, Striebich Christopher C, Feser Marie L, O'Dell James R, James Judith A, Sparks Jeffrey A, Davis John M, Graf Jonathan, McMahon Maureen A, Solow Elizabeth B, Forbess Lindsy J, Tiliakos Athan, Schiopu Elena, Danila Maria I, Horowitz Diane L, Kay Jonathan, Strickland Colin D, Guthridge Joel M, Arriens Cristina, Grossman Jennifer M, Kristen Demoruelle M, Bemis Elizabeth A, Frazer-Abel Ashley, Fleischer Chelsie L, Fox David A, Mikuls Ted R, Greenleaf Melissa, York Kate, Walker Sarah, Keyes-Elstein Lynette, Byron Margie, Fedler Janel, Goldmuntz Ellen A, Holers V Michael
Аннотация
METHODS: In this phase 2 randomized trial, individuals at risk for RA with anti-CCP3 ≥2 times the upper limit of normal (ULN) were assigned to receive HCQ or placebo for 12 months, with up to 24 months of postdrug follow-up. The primary outcome was the development of clinical RA, as defined in the protocol, at 36 months. Secondary outcomes included safety, development of inflammatory arthritis (IA), and participant-reported joint symptoms.
RESULTS: Of 144 randomized participants, 71 were assigned to HCQ and 73 to placebo. In the modified intent-to-treat population, clinical RA occurred in 21 of 69 (30.4%) participants in the HCQ group and 24 of 73 (32.9%) in the placebo group. The risk of clinical RA at 36 months was 0.336 with HCQ and 0.394 with placebo (difference -0.058; 95% confidence interval -0.336 to 0.220; P = 0.52). Results for IA were similar. The occurrence and severity of joint symptoms were not observed to differ between groups. Adverse event incidence was similar between groups.
CONCLUSION: In this trial involving individuals with anti-CCP3 levels ≥2 times the ULN, 12 months of HCQ did not prevent the development of clinical RA at 36 months.