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An off-label drug prescribed to treat osteoarthritis of the hand when conventional medication has failed is ineffective, according to new research.

Research challenges use of off label drug to treat osteoarthritis

The HERO trial shows there was no benefit in taking hydroxychloroquine to control debilitating pain when compared to a placebo (dummy substance).

Current drug treatments for hand OA can include paracetamol, non-steroidal anti-inflammatory drugs or opioids but  they do not always improve patients’ symptoms and some people experience adverse reactions to them. Doctors have used hydroxychloroquine as an off-label alternative.


We still have no disease modifying drugs or disease-specific drugs targeting pain for this common, disabling condition.
- Dr Fiona Watt, University Research Lecturer and HERO investigator

Rheumatologist and University Research Lecturer Fiona Watt said: "We are of course sorely disappointed at the findings, which tell us that hydroxychloroquine is not better than a placebo (dummy treatment) at treating pain associated with hand OA. This means we still have no disease modifying drugs or disease-specific drugs targeting pain for this common, disabling condition. "

Prescription drugs are licensed for certain conditions: off-label use means doctors are using them to treat illnesses outside of that designated or authorised list.

It is not clear how often doctors use hydroxychloroquine off-label although it is believed to be a common practice.

Lead researcher Dr Sarah Kingsbury, from the University of Leeds and NIHR Leeds Biomedical Research Centre at Chapel Allerton Hospital, said: “There is some scientific basis as to why hydroxychloroquine could be an effective drug agent.

“It is known to target inflammation in the joints and is a recognised and licensed treatment for rheumatoid arthritis.

“There is increasing evidence that inflammation is a factor in osteoarthritis. So doctors have used hydroxychloroquine off-label, in a way that it was not licensed for, to try and control symptoms and pain.

“But until now, there has not been a large-scale study into whether using hydroxychloroquine works. And our evidence shows that for most patients it is not an effective treatment.”

Dr Watt adds: "The study's findings underline our re-doubling of efforts in the Arthritis Research UK Centre for OA Pathogenesis to understand basic mechanisms in hand OA and identify new drug targets. The trial is also a practice-changer, protecting patients with symptomatic small joint hand OA from unnecessary exposure to drugs which do not work: an important outcome for negative clinical trials such as this."

Painful and disabling condition 

Osteoarthritis of the hand is a painful and disabling condition which tends to affect people as they get older. It can stop people from carrying out everyday activities – and can limit their quality of life.

The research study, funded by Arthritis Research UK, and published in the journal Annals of Internal Medicine estimated that up to 31 per cent of people aged over 70 suffer from the condition.

The study involved 248 patients at 13 NHS hospitals in England: all had the condition for at least five years and had changes to the joints in their hands consistent with osteoarthritis.

The participants all reported moderate to severe pain on at least half of the days in the previous three months to the study commencing.

No benefit from drug 

The study found that patients initially reported a small reduction in the severity of pain before the improvement plateaued. However, that change was seen in both the group receiving the medication and the group taking the placebo.

Measurements of grip strength and the structural damage existing in patients’ joints were similar for both groups.

Dr Kingsbury said: “Our findings do not support the current medical practice of giving hydroxychloroquine to patients with hand osteoarthritis.”

Figures from Arthritis Research UK show that 8.75 million people over the age of 45 have sought treatment for all types of osteoarthritis. One third have to stop working or reduce their working hours because of the pain of the condition.

According to the charity, hand osteoarthritis is more commonly seen in people whose occupations required increased manual dexterity.

Dr Natalie Carter, head of research liaison and evaluation at Arthritis Research UK, said: “While this drug is known to be effective for some forms of inflammatory arthritis, such as rheumatoid arthritis, this study does not back up its use for hand osteoarthritis.

Hand osteoarthritis can have a huge impact on a person’s life, limiting their ability to live independently and carry out everyday tasks such as dress, wash and cook for themselves.

“It is vital that we invest in research to improve the treatment options available to people with this condition. Anyone concerned about the effectiveness of their treatment should seek advice from their doctor.”

The delivery of this large clinical trial in hand OA funded by Arthritis Research UK was a huge combined effort across a network of UK universities with research interests in hand OA, including Oxford: recruitment from investigators at the Kennedy Institute of Rheumatology and Botnar Research Centre in Oxford jointly contributed the second largest group of participants to the study.