Hydroxychloroquine not effective in patients with hand osteoarthritis

Data from the first large, randomised, placebo-controlled trial 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 [1].

Treatment of hand osteoarthritis is complicated as common analgesics and non-steroidal anti-inflammatory drugs (NSAIDs) used for symptomatic relief 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) presented the results of the randomised, double-blind, placebo controlled, multicentre, investigator-initiated, phase 3 OA-TREAT trial, assessing the efficacy and safety of hydroxychloroquine in patients with inflammatory and erosive hand osteoarthritis.

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.

The results showed that only morning stiffness was significantly reduced in those patients receiving hydroxychloroquine (P=0.001), while changes in radiographic scores did not differ significantly (P>0.05) between both treatment groups (see Table). Regarding safety, 7 serious adverse events were reported in the hydroxychloroquine group versus 15 in the placebo group. No new safety issues were detected. The genesis of stiffness in hand OA could certainly differ from RA and these findings on improvement in stiffness may warrant further investigation.

 

Table: ANCOVA-adjusted mean values and 95% CI for primary and secondary outcomes at week 52 [1]

The associated baseline value or, if available, a mean value from baseline and screening was included in the ANCOVA model as a covariate.

1. Kedor C, et al. Abstract OP0186. EULAR E-Congress, 3-6 June 2020.

Posted on 14 August 202017 May 2024