ROME – Hydroxychloroquine should not be prescribed for patients with mild to moderate hand osteoarthritis (OA) according to data from a 24-week, randomized, multicenter, placebo-controlled trial.
The results of the Dutch study, presented at the European Congress of Rheumatology by Dr. Natalja M. Basoski of Maasstad Hospital, Rotterdam, the Netherlands, showed that hydroxychloroquine was no better than placebo at reducing patients’ pain and disability, or for improving their physical, social, or emotional well-being.
Dr. Natalja M. Basoski
The primary outcome measure used was reduction in OA hand pain in the preceding 24 hours measured using a 100-mm visual analog scale (VAS) at the end of the study. The mean change in pain using the VAS over 24 weeks was a reduction of 1.3 mm in the hydroxychloroquine-treated patients versus a 0.10-mm rise in the patients who received placebo (P = .82).
There also was no change in the two secondary endpoints of change in total score of the Australian/Canadian Hand Osteoarthritis Index (AUSCAN) and the Arthritis Impact Measurement Scale 2 SF (AIMS2-SF) by the end of the treatment period. Mean changes in AUSCAN total scores were –0.42 and –0.25 (P = .49) and mean reductions in total AIMS2-SF scores were –0.17 and –0.076 (P = .68), comparing hydroxychloroquine with placebo, respectively.
“Osteoarthritis of the hand is one of the most common types of osteoarthritis, leading to pain, stiffness, and loss of function,” Dr. Basoski explained during a clinical science session looking at manifestations of the disease beyond the knee. “Unfortunately, current pharmacological treatment options are limited,” she added.
The underlying pathophysiological mechanisms of OA that primarily affect the hand are not clear, although inflammation is known to have a role, as in knee OA. Hydroxychloroquine is an established disease-modifying antirheumatoid drug that has shown benefit in patients with mild rheumatoid arthritis, which has led many rheumatologists to prescribe off label for the treatment of hand OA as well, Dr. Basoski observed in an interview. Data to support this are lacking, however, so this trial aimed to look at the potential symptom-modifying effects of the drug specifically in OA.
Over a 3-year period starting in July 2010, 202 patients with symptoms of primary mild to moderate hand OA of at least 1 years’ duration were recruited at six hospitals in the Netherlands and randomized to hydroxychloroquine 400 mg/day or matching placebo for 24 weeks. Six patients were lost to follow-up early on in the study, leaving 98 patients in each study arm who could be included in the intent-to-treat analysis. Of these, 22 hydroxychloroquine-treated and nine placebo-treated patients discontinued treatment, 10 and 5 in each group, respectively, because of adverse effects.
Dr. Basoski noted that patient characteristics were similar at baseline. Mean age was 57 years, and about 86% of participants were women. Hand OA was defined via American College of Rheumatology criteria and 86% and 91% of hydroxychloroquine- and placebo-treated patients had at least one joint with radiographic evidence of joint disease defined as a Kellgren-Lawrence score of ≥2.
“This is one of the studies that does not support the use of hydroxychloroquine in patients with OA of the hands and mild complaints,” she said in an interview. “It means that you should not prescribe it anymore, at least based on the results of this study.”
Further research is needed to see if there are some patients who might benefit or if it applies to other OA phenotypes, such as erosive hand OA. “More studies should be done, although in our second analysis after the study we tried to differentiate between very low pain and high pain and we still didn’t really see a difference,” she observed.
Erosive hand OA could be a different case, and results of an ongoing UK study should provide insight on whether hydroxychloroquine could be beneficial in these patients.
Although a similar number of patients treated with hydroxychloroquine or placebo in the trial experienced adverse events (21 vs. 24, respectively), there was an increase in allergic reactions (3 vs. 0) and rash or itching (8 vs. 3) with the active treatment.
With hydroxychloroquine seemingly out of the picture, at least in mild to moderate cases, Dr. Basoski advised on how she might treat a patient with primary hand OA. “I would try to start with paracetamol [acetaminophen] at the dose that is currently recommended, like 4 g/day, then eventually try to use opioids, as NSAIDs are not such a good thing to use in the long term.”
Dr. Basoski did not have any conflicts of interest to disclose.