medwireNews: Results of the HERO trial suggest that the addition of hydroxychloroquine to standard care does not further reduce pain among patients with hand osteoarthritis (OA).
“Increasing evidence [suggests] that inflammation is prevalent in osteoarthritis and may have a role in symptoms,” and the HERO (Hydroxychloroquine Effectiveness in Reducing symptoms of hand Osteoarthritis) trial was designed to replicate anecdotal evidence suggesting a reduction in pain with off-label use of hydroxychloroquine, explain Sarah Kingsbury (Chapel Allerton Hospital, Leeds, UK) and co-investigators.
However, the trial results present “no evidence that [hydroxychloroquine] should be considered within the management plan of patients with hand osteoarthritis,” they say.
As reported in the Annals of Internal Medicine, patients with symptomatic and radiographic hand OA from 13 UK centers were randomly assigned to receive hydroxychloroquine 200–400 mg once daily (maximum dose 6.5 mg/kg per day) or placebo alongside usual care.
The majority (89.9%) of participants were also receiving analgesic medication, including nonsteroidal anti-inflammatory drugs, acetaminophen, and opioids. Mean hand pain scores at baseline – measured as overall pain severity in the previous 2 weeks on a 0- to 10-point numeric rating scale – were 6.9 points for the 113 patients given hydroxychloroquine and 6.8 points for the 119 participants in the placebo group.
At the 6-month follow-up, average hand pain scores were not significantly different between the hydroxychloroquine and placebo groups, at 5.66 and 5.49 points, respectively, giving a nonsignificant between-group difference of 0.16 points.
Furthermore, there were no significant differences in grip strength, Kallman total radiographic score, quality of life, or self-reported physical and mental health between the groups at 6 months, and the results remained consistent at the 12-month follow-up.
In subgroup analyses, the researchers observed no significant effect of hydroxychloroquine treatment in patients with and without synovitis at baseline.
“The failure of [hydroxychloroquine] as an analgesic in this study may reflect its mild anti-inflammatory activity, suboptimal dosing, or that the level or type of inflammation in our population did not match the mechanism of [hydroxychloroquine],” write Kingsbury and colleagues.
Although hydroxychloroquine demonstrated no benefits in the trial, the authors of an accompanying editorial, Elena Losina and Jeffrey Katz (both from Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA), believe that “[t]he hypothesis that synovitis plays an important role in the pathogenesis of hand osteoarthritis should not be dismissed on the basis of the HERO trial findings.”
Hydroxychloroquine is “seldom used in contemporary practice as a solo disease-modifying therapy for rheumatoid arthritis and other inflammatory conditions,” they add.
And the editorialists conclude that future studies of anti-inflammatory agents for hand OA “will need to use more potent agents or compounds developed to more specifically target the inflammatory pathways documented in this condition.”
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