ATLANTA — Low-dose oral prednisolone was effective and well tolerated in the treatment of painful hand osteoarthritis (OA), according to study results presented at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, November 8 to 13, 2019, in Atlanta, Georgia.
Investigators conducted a randomized, double-blind, placebo-controlled trial of low-dose oral prednisolone in the treatment of painful hand OA. Eligible patients fulfilled the ACR criteria for OA, with signs of synovial inflammation, ≥4 interphalangeal joints (IPJ) with osteoarthritic nodes, ≥1 IPJ with soft swelling or erythema, and ≥1 IPJ with a positive power Doppler signal (PDS) or ≥2 synovitis grade on the ultrasound. Patients with visual analog scale (VAS) finger pain ≥30 mm and flaring ≥20 mm on nonsteroidal anti-inflammatory drug washout were randomly assigned to receive either prednisolone 10 mg/d for 6 weeks or placebo. The study period was followed by a 2-week tapering scheme and a 6-week period without study medication. Outcomes were assessed at 2, 4, 6, 8, and 14 weeks. The primary end point was VAS finger pain at week 6 in the intention-to-treat analysis. Secondary end points included fulfillment of Osteoarthritis Research Society International (OARSI) responder criteria, hand function and pain, grip strength, ultrasound synovitis, and PDS.
Among 92 patients (mean age, 63.9±8.8 years; 79% women) receiving prednisolone or placebo, 42 patients in each group completed the trial. The mean change from baseline to week 6 in VAS finger pain was -21.5±21.7 in the prednisolone group compared with -5.2±24.3 in the placebo group (mean group difference, -16.5). At week 6, compared with 15 (33%) patients in the placebo group, 33 (72%) in prednisolone group fulfilled OARSI responder criteria, (odds ratio, 5.3; 95% CI, 2.0-13.6; P =.001).
Prednisolone was also associated with greater improvements in secondary clinical end points, including Australian/Canadian Hand OA Index pain/function, Functional Index for Hand OA, VAS patient global assessment, Short-Form 36 physical component scale, and grip strength. However, no between-group differences were observed for PDS. Adverse events were largely mild and occurred at comparable rates between groups. During the tapering period, outcome differences between the prednisolone and placebo groups disappeared.
According to these data, 6-week treatment with low-dose oral prednisolone may be a suitable treatment option for patients with hand OA and signs of inflammation.
“This trial provides evidence that local inflammation is a suitable target for drug-treatment in hand OA,” the researchers concluded.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Kroon F, Kortekaas M, Boonen A, et al. Six-week treatment with low-dose prednisolone in patients with painful hand osteoarthritis (HOPE): Results from a randomised double-blind placebo-controlled trial. Presented at: 2019 ACR/ARP Annual Meeting; November 8-13, 2019; Atlanta, GA. Abstract 1760.