MADRID -- Patients diagnosed with osteoarthritis that causes hand and finger pain got relief with low-dose prednisolone, according to a study reported here at the annual European Congress of Rheumatology, sponsored by the .
Among 46 patients receiving prednisolone 10 mg in a randomized trial, their pain was improved by a mean 16.5 points on a 100-point visual analog scale after 6 weeks of treatment relative to 46 patients assigned to placebo (P<0.001), reported Féline Kroon, MD, a PhD candidate at Leiden University Medical Center in The Netherlands.
At baseline, patients assigned to prednisolone had an average visual analog scale pain score of 55.5, which was decreased by 23.6 points after 6 weeks of therapy; patients assigned to placebo had a score of 55.7, which was decreased by an average of 8.0 points.
"Our study provides evidence that local inflammation is a suitable target for drug treatment in hand osteoarthritis," she said at a press conference at the meeting. "Significant improvements in pain and function were seen in the trial, meaning that prednisolone could be considered by physicians treating people suffering with hand osteoarthritis."
The study also found that on the Australian/Canadian Osteoarthritis Index, patients treated with prednisolone recorded an average reduction of 3.5 points compared with patients treated with placebo (P<0.001).
In addition, 72% of patients on steroids compared with 33% of patients treated with placebo achieved classification as responders to therapy using the OMERACT-OARSI (Outcome variables for osteoarthritis clinical trials of the Osteoarthritis Research Society International) responder criteria.
"We believe that prednisolone may be a treatment option in hand osteoarthritis, although future studies investigating treatment dosage and duration are needed," Kroon told Ƶ. She said that at this point the treatment should be used when patients experience pain flares because long-term use of glucocorticoids is not recommended.
She added that treatment with steroids should be limited to patients who have signs that their condition involves inflammation, which is the target of the drugs.
Hand osteoarthritis is a common joint disease, characterized by stiff and painful joints. Treatments are currently limited to topical and oral non-steroidal anti-inflammatory drugs (NSAIDs) to relieve pain. However, studies have shown that synovial inflammation is often present in hand osteoarthritis, and it is this inflammation that is a main determinant of pain and radiographic disease progression, identifying synovitis as a possible target of treatment.
While glucocorticoids such as prednisolone have been used to reduce inflammation in rheumatoid arthritis, their use has not been recommended for osteoarthritis due to lack of evidence, noted John D. Isaacs, MBBS, PhD, of The Newcastle upon Tyne Hospitals in England and chairperson of the EULAR Abstract Selection Committee.
"Hand osteoarthritis is a common musculoskeletal disease, with prevalence rising steeply with increasing age," he told Ƶ. "Oral glucocorticoid therapy was not included in the recent treatment guidelines update due to limited conflicting data. Therefore, we welcome these positive results that provide further controlled evidence in this area."
"I think this treatment is being used now off-label. I agree that we need more work," he said, adding that he would like to see a study comparing NSAIDS and prednisolone.
Kroon said such a study has never been done, but would be an interesting trial.
The so-called HOPE study was designed as a randomized, double-blind, placebo-controlled trial of 92 patients with painful hand osteoarthritis diagnosed based on criteria of the American College of Rheumatology, and if the condition exhibited signs of synovial inflammation. Eligible patients were randomized to receive prednisolone 10 mg daily for 6 weeks or placebo, followed by a 2-week tapering scheme and 6 weeks without study medication.
The mean age of patients was 63.9, and 79% were women, with baseline characteristics well-balanced between the groups, Kroon continued. After tapering, all between-group differences disappeared, and adverse events were mostly mild and comparable between groups.
Outcomes were assessed at 2, 4, and 6 weeks, at which time tapering of the steroids was begun. Another assessment was taken at week 8, and a final one was performed at week 14. The primary endpoint was visual analog scale finger pain at week 6 in an intention-to-treat analysis.
Disclosures
Kroon reported having no relevant relationships with industry.
Isaacs reported having financial relationships with Pfizer, AbbVie, Roche, Galvani, Merck, Gilead, Eli Lilly, Amgen, Janssen, Celltrion, and NAPP.
Primary Source
European League Against Rheumatism
Kroon F, et al "Low-dose Prednisolone in Patients with Hand Osteoarthritis (HOPE): Results from a Randomised Double-Blind Placebo-Controlled Trial" EULAR 2019; Abstract OP0180.