OBJECTIVE: To determine the symptom-modifying effect of hydroxychloroquine (HCQ) in hand osteoarthritis (OA). METHODS: In this randomized, double-blind, multicenter trial, patients with symptomatic hand OA received either HCQ 400 mg once a day or placebo during 24 weeks. The primary outcome was change of pain measured on a 100-mm visual analog scale (VAS) at 24 weeks. Secondary outcomes included decrease of pain at weeks 6 and 12 and change in Australian Canadian Hand Osteoarthritis Index (AUSCAN) and Arthritis Impact Measurement Scale 2 short form (AIMS2-SF) total scores. RESULTS: A total of 196 patients was included (placebo n = 98, HCQ n = 98). Mean ±SD age was 58.0 ± 7.6 years, and 86% were female. Baseline mean ±SD painVAS was 44.9 ± 22.9 mm in the placebo group and 43.2 ± 22.3 mm in the HCQ group. At 24 weeks, change in painVAS was not significantly different between both groups (imputed mean VAS 42.7 in the HCQ group versus 45.3 in the placebo group after 24 weeks), as was the case in painVAS at weeks 6 and 12. Changes in AUSCAN total score and AIMS2-SFtotal score in both groups were similar between the groups. In total, 24 patients in the placebo group and 21 patients in the HCQ group reported ≥1 adverse event. In the HCQ group, 3 patients reported a severe allergic reaction. Fifteen patients withdrew from the study (5 placebo, 10 HCQ group) due to adverse events. CONCLUSION: Treatment with HCQ at 24 weeks is not effective in reducing the symptoms of hand OA compared to placebo.
RCT Entities:
OBJECTIVE: To determine the symptom-modifying effect of hydroxychloroquine (HCQ) in hand osteoarthritis (OA). METHODS: In this randomized, double-blind, multicenter trial, patients with symptomatic hand OA received either HCQ 400 mg once a day or placebo during 24 weeks. The primary outcome was change of pain measured on a 100-mm visual analog scale (VAS) at 24 weeks. Secondary outcomes included decrease of pain at weeks 6 and 12 and change in Australian Canadian Hand Osteoarthritis Index (AUSCAN) and Arthritis Impact Measurement Scale 2 short form (AIMS2-SF) total scores. RESULTS: A total of 196 patients was included (placebo n = 98, HCQ n = 98). Mean ± SD age was 58.0 ± 7.6 years, and 86% were female. Baseline mean ± SD pain VAS was 44.9 ± 22.9 mm in the placebo group and 43.2 ± 22.3 mm in the HCQ group. At 24 weeks, change in pain VAS was not significantly different between both groups (imputed mean VAS 42.7 in the HCQ group versus 45.3 in the placebo group after 24 weeks), as was the case in pain VAS at weeks 6 and 12. Changes in AUSCAN total score and AIMS2-SF total score in both groups were similar between the groups. In total, 24 patients in the placebo group and 21 patients in the HCQ group reported ≥1 adverse event. In the HCQ group, 3 patients reported a severe allergic reaction. Fifteen patients withdrew from the study (5 placebo, 10 HCQ group) due to adverse events. CONCLUSION: Treatment with HCQ at 24 weeks is not effective in reducing the symptoms of hand OA compared to placebo.
Authors: Claudia Kedor; Jacqueline Detert; Rolf Rau; Siegfried Wassenberg; Joachim Listing; Pascal Klaus; Tanja Braun; Walter Hermann; Stefan Markus Weiner; Frank Buttgereit; Gerd R Burmester Journal: RMD Open Date: 2021-07