ATLANTA – Dutch investigators at the annual meeting of the American College of Rheumatology made a good case for 6 weeks of low-dose prednisolone to help people with hand osteoarthritis get over a particularly bad spell.
A total of 42 patients randomized to prednisolone 10 mg/day fell a mean of 21.5 mm at 6 weeks from a baseline visual analog hand pain score of 54 mm (out of a possible 100 mm), versus a drop of 5.2 mm from a baseline score of 53 mm among 46 randomized to placebo; the mean group difference was 16.5 mm. Patients taking prednisolone did better on function, quality of life, and physician global assessments, too.
“This trial provides evidence that local inflammation is a suitable target for drug treatment in hand OA. We think this study provides clinicians with a short-term treatment option for patients who have a flare of their disease,” said lead investigator, MD, a rheumatologist at Leiden (the Netherlands) University Medical Center.
“The large beneficial effect size exceeded that of all available therapeutic options for hand osteoarthritis,” including NSAIDs, she and her team noted in the study, which was published to coincide with the meeting (Lancet. 2019 Nov 30;394:1993-2001).
Many physicians already use short-course prednisolone for hand OA, but there was no clinical evidence that it helped until now. The study also adds weight to the idea that OA has an inflammatory component – an idea that has been building for a while, Dr. Kroon said.
Leiden investigators and others have previously shown that synovial inflammation is often present in hand OA and a main determinant of pain and radiographic progression.
The 92 patients in the Low-Dose Prednisolone in Patients with Painful Hand Osteoarthritis (HOPE) trial had to have at least four interphalangeal joints (IPJs) with osteoarthritic nodes, at least one IPJ with soft swelling or erythema, and at least one with a positive power Doppler signal or grade 2 or higher synovitis on ultrasound. They also had to have flared at least 20 mm on the pain scale with NSAID washout.
There were more responders in the prednisolone group at 6 weeks (72% versus 33%), and significantly greater improvement in synovial thickening. There was no difference in power Doppler score or synovitis score per joint on MRI, but bone marrow lesions appeared less severe with prednisolone.
All the between-group differences disappeared when prednisolone was tapered after 6 weeks.
Four patients discontinued the study because of an adverse event: a myocardial infarction in the prednisolone group, and, in the control arm, a bowel surgery, an infected leg hematoma, and a case of Lyme arthritis of the knee. Adverse events were otherwise mild and similar in both arms.
The mean age in the study was 64 years, and 79% of the subjects were women. Exclusion criteria included chronic inflammatory rheumatic diseases, psoriasis, use of immune-modulating drugs within 90 days of baseline, and predominantly thumb base pain instead of finger pain.
The approach “is for short course. Long-term steroids can have important side effects, like osteoporosis. We do not think this study should be used to encourage prolonged prescribing of glucocorticoids in patients with hand OA,” Dr. Kroon said.
Two previous trials of glucocorticoids for hand OA were inconclusive. A dose of prednisone 5 mg/day for 4 weeks did not separate from placebo in one, and the second showed pain improvements with a combination of prednisolone and dipyridamole versus placebo, but with more adverse events, particularly dipyridamole headaches.
The work was funded by the Dutch Arthritis Society. Dr. Kroon did not have any disclosures.
SOURCE: Kroon F et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract .