Hydroxychloroquine was no more effective than placebo in reducing symptoms or radiographic progression in patients with moderate to severe hand pain and radiographic osteoarthritis (OA), according to the results of a randomized, double-blind, controlled clinical trial published in the Annals of Internal Medicine.
Investigators randomly assigned 248 participants (82% women; mean age, 62.7 years) with symptomatic and radiographic hand OA to receive hydroxychloroquine (200 to 400 mg) or placebo for 12 months in addition to ongoing usual care. The primary end point of the study was average hand pain after 6 months of treatment, measured on a 0 to 10 numeric scale.
The researchers found that the mean hand pain score was 5.49 points in the placebo group and 5.66 points in the hydroxychloroquine group, with a treatment difference of –0.16 points (95% CI, –0.73 to 0.40; P =.57). Results were adjusted for adherence, missing data, and use of rescue medication.
The investigators note that no significant treatment differences existed at 3, 6, or 12 months for secondary end points, including self-reported pain and function, grip strength, quality of life, radiographic structural change, and adverse events.
Results also showed that 94% of participants had at least 1 joint with synovitis on grayscale ultrasonography and 54% had synovitis as assessed by power Doppler. A total of 15 serious adverse events were reported, including 7 in the hydroxychloroquine group and 8 in the placebo group.
“Our findings in this full-scale pragmatic trial do not support the current practice of off-label use of [hydroxychloroquine] in patients with hand osteoarthritis,” the authors concluded.
Kingsbury SR, Tharmanathan P, Keding A, et al. Hydroxychloroquine effectiveness in reducing symptoms of hand osteoarthritis: a randomized trial [published online February 19, 2018]. Ann Intern Med. doi:10.7326/M17-1430