medwireNews: Findings from the HOPE trial indicate that short-term treatment with prednisolone may provide pain relief for patients with hand osteoarthritis (OA) experiencing a flare following withdrawal of nonsteroidal anti-inflammatory drugs (NSAIDs).
“These findings provide clinicians with a new treatment option for a disease that that has very few therapeutic options,” Féline Kroon (Leiden University Medical Center, the Netherlands) and co-investigators write in The Lancet.
The trial, which was reported simultaneously at the 2019 ACR/ARP Annual Meeting in Atlanta, Georgia, USA, included 92 OA patients with evidence of synovial inflammation and finger pain of at least 30 mm on a 100-mm visual analog scale (VAS) that worsened by at least 20 mm during the 48 hours following NSAID withdrawal.
Kroon et al found that finger pain improved to a significantly greater degree from baseline to week 6 among the 46 participants who were randomly assigned to receive 10 mg prednisolone once daily compared with the 46 patients given placebo, with average reductions in VAS scores of 21.5 mm versus 5.2 mm, and a mean between-group difference of 16.4 points after adjustment for age and sex.
After 6 weeks, prednisolone was tapered for 2 weeks, at which time the average difference in VAS finger pain score of 8.5 points between the prednisolone and placebo groups was no longer statistically significant, and reduced further still to 6.6 points at the final 14-week follow-up.
The HOPE (Hand Osteoarthritis Prednisolone Efficacy) investigators say that prednisolone performed “consistently better than placebo” over 6 weeks in a number of secondary outcomes, including Australian–Canadian Hand Osteoarthritis Index function score, patient global assessment VAS, and synovial thickening as measured by ultrasound.
Discussing these results in an accompanying comment, Graeme Jones and Tania Winzenberg, both from the University of Tasmania in Hobart, Australia, say that prednisolone represents “a clear and effective short-term option for those with hand osteoarthritis pain that flares up in response to withdrawal of NSAIDs, especially if they have symptoms and signs of inflammation, such as night pain, morning stiffness, and soft tissue swelling.”
They believe that if “these signs and symptoms were present, we would not see the need to image the joints […] meaning that this treatment approach could be used not only by specialist rheumatologists but also in primary care for patients with more severe disease.”
In the safety analysis, an identical number of non-serious adverse events occurred in both groups (n=43), while one and four serious adverse events were reported in the prednisolone and placebo arms, respectively.
Kroon and team say that there were “no safety signals for a short course of 10 mg prednisolone daily,” but caution that “prolonged glucocorticoid treatment can lead to serious complications, the risk of which increases with increased dose and duration of therapy.”
And they conclude: “Future studies to investigate the optimal dosage and duration of treatment are warranted, possibly in trials employing treat-to-target strategies.”
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Lancet 2019; doi:10.1016/S0140-6736(19)32489-4
Lancet 2019; doi:10.1016/S0140-6736(19)32729-1
ACR/ARP 2019; Atlanta, Georgia, USA: 8–13 November