Data from the first large, randomized, placebo-controlled trial OA TREAT, focusing on erosive hand osteoarthritis, showed that hydroxychloroquine was no more effective than placebo for changes in pain, function, and radiographic scores in the 52-week period of the study .
Treatment of hand osteoarthritis is complicated, as common analgesics and non-steroidal anti-inflammatory drugs (NSAIDs) are used for symptomatic relief but are often poorly tolerated or contraindicated especially in elderly patients. At the same time, no effective and proven disease-modifying therapy is available. Dr Claudia Kedor (Charité–Universitätsmedizin Berlin, Germany) et al. investigated the efficacy and safety of hydroxychloroquine in patients with inflammatory and erosive hand osteoarthritis in a randomised, double-blind, placebo-controlled, multicentre, investigator-initiated trial (OA TREAT).
Patients with inflammatory and erosive hand osteoarthritis were randomised to hydroxychloroquine 200-400 mg per day (n=75) or matching placebo for 52 weeks (n=78). Both groups received standard therapy (stable NSAIDs). The primary endpoint was AUStralian CANadian Osteoarthritis Hand Index (AUSCAN) for pain and hand disability at week 52; the secondary endpoint was radiographic progression from baseline to week 52. Mean age of the patients was 52.4 years in the hydroxychloroquine group and 50.2 years in the placebo group. The percentage of female patients was 90.7% and 76.9%, respectively, and disease duration was 9.5 and 10.8 years, respectively. Baseline pain (AUSCAN) was 31.1 and 30.7, respectively, while baseline function (AUSCAN) was 58.5 and 57.8, respectively.
It was found that only morning stiffness was significantly reduced in those patients receiving hydroxychloroquine (P=0.001), whilst changes in radiographic scores did not differ significantly between both treatment groups. Regarding safety, there were 7 serious adverse events in the hydroxychloroquine group versus 15 in the placebo group. No new safety issues were detected.
1. Kedor C, et al. Hydroxychloroquine in patients with inflammatory and erosive osteoarthritis of the hands: results of a randomized, double-blind, placebo controlled, multi-centre, investigator-initiated Trial (OA TREAT). OP0186. EULAR 2020.