In a large, head-to-head trial pitting collagenase injections against limited fasciotomy as treatments for Dupuytren’s contracture, the knife won.
In the open-label trial, self-reported hand health scores at 1 year favored the surgical procedure, averaging 17.8 among patients randomized to collagenase injections versus 11.9 for the limited-fasciotomy group on the Patient Evaluation Measure-Hand Health Profile (PEM) questionnaire (difference 5.9, 95% CI 3.1-8.8), according to Joseph Dias, MD, of University Hospitals of Leicester NHS Trust in England, and colleagues.
With other measures also coming down on the side of fasciotomy in the 599-patient primary analysis, the injections were deemed “not noninferior” to surgery in the trial, the researchers reported in the New England Journal of Medicine.
The so-called DISC study offers one of the best answers to the longstanding question of whether collagenase injections are a good, if not superior, alternative to limited fasciotomy in relieving Dupuytren’s contracture. Patients with the condition develop fibrous rope-like structures in the hand and wrist, forcing the fingers to curl up to the point of impairing hand function.
Both types of treatment are aimed at breaking down these fibrous cords. Collagenase works by weakening the cords enough that, several days after injection, a clinician can manually break them and unbend the fingers. With limited fasciotomy, the cords are simply cut and removed. Neither treatment affects the (somewhat mysterious) underlying disease process and repeat procedures are often needed.
As Dias and colleagues explained, surgical therapy is more common in practice, but collagenase injections are an increasingly popular alternative in that it can be performed in an office setting and recovery is quicker. But whether it is equivalent in efficacy has been debated. One retrospective analysis in 2020 found in favor of collagenase, but a recent prospective trial yielded results similar to those seen in the current study.
Dias’s group emphasized that the findings shouldn’t be interpreted as closing the door on collagenase injections. These “may be preferred by patients who prioritize avoiding the higher risk of moderate-to-severe complications and longer time to improvement associated with surgery.” Indeed, 23 of the 336 randomized to fasciotomy declined to undergo it after learning their assignment, compared with four among those randomized to the injections.
DISC (Dupuytren’s Interventions Surgery vs Collagenase) randomized 672 patients in equal numbers to limited fasciotomy or collagenase injections. To be eligible, participants needed to have finger contractures of at least 30° in a metacarpophalangeal proximal interphalangeal joint amenable to either procedure. Patients with extremely severe contractures (>135°) were excluded.
The primary analysis was performed on the 599 patients who underwent the procedures and were retained long enough to provide useful data.
Mean patient age was about 66 years and close to 80% were men. Baseline PEM scores averaged about 34 on its 100-point scale, in which higher scores equate to worse function.
Additional patient-reported PEM scores were collected at months 3, 6, 12, and 24. Scores on the Single Assessment Numeric Evaluation (SANE), Unité Rhumatologique des Affections de la Main (URAM), and Michigan Hand Outcomes Questionnaire (MHQ) served as secondary efficacy measures.
PEM scores at month 3 were higher in the fasciotomy group; the same was true with SANE scores. URAM initially showed no difference between treatments but by month 6, fasciotomy had come out ahead. The MHQ was only administered at baseline and months 12 and 24; at both post-treatment evaluations, fasciotomy was clearly superior.
Findings were similar for objective measures of finger extension. Also, 14.6% of the collagenase group had a repeat treatment for a recurrent contracture during the 2-year study period, compared with 3.4% of those having surgery.
On the negative side for surgery, moderate or severe complications were significantly more common in that group (5.1% vs 1.8%). One patient undergoing fasciotomy ultimately required amputation of the little finger; another had painful, refractory hand swelling, and a third lost sensation in one finger. Nerve-related events were reported for 42 patients undergoing surgery versus 18 receiving injections.
Overall, however, most patients in both groups had no adverse events, and the vast majority of complications were rated as very minor or mild.
Despite the trial’s prospective, randomized design, Dias and colleagues noted several limitations. It was unblinded, and was conducted during the COVID-19 pandemic that disrupted “provision of care” in various ways. As well, 2 years were probably not sufficient to capture the full durability of each treatment type; “[l]onger-term follow-up is needed to better assess the progression of contracture and the incidence of reintervention over time,” the authors wrote.
John Gever was Managing Editor from 2014 to 2021; he is now a regular contributor.
Disclosures
The trial was funded by the U.K. National Institute of Health and Care Research.
Dias had no relevant disclosures.
One study coauthor reported serving on a data safety and monitoring board for a collagenase drug trial sponsored by Fidia.
Primary Source
New England Journal of Medicine
Source Reference: Dias J, et al “Collagenase injection versus limited fasciectomy for Dupuytren’s contracture” N Engl J Med 2024; DOI: 10.1056/NEJMoa2312631.
Source : MedPageToday