Adalimumab Does Not Improve Clinical Outcomes After Needle Fasciotomy for Dupuytren Contracture: A Randomized Controlled Pilot Trial

Background Dupuytren disease is a fibroproliferative disorder in which tumor necrosis factor (TNF)–driven myofibroblast activity contributes to progressive digital flexion contractures by causing collagen deposition. Needle fasciotomy mechanically releases established collagen cords but does not target the underlying fibroproliferative process. Adalimumab, an anti-TNF agent, has been shown to reduce nodule hardness in early-stage Dupuytren disease, but it remains unknown whether it has additional impact combined with needle fasciotomy in more established contractures. Questions/purposes (1) Does a single perioperative intralesional injection of adalimumab immediately after needle fasciotomy increase the proportion of patients achieving at least 10° improvement in total passive extension deficit (TPED)? (2) Does adalimumab improve the change in TPED at 3 and 12 months? (3) Does adalimumab improve VAS pain and QuickDASH scores at 3 and 12 months? (4) What complications occurred in the adalimumab and placebo groups? Methods We conducted a double-blind, randomized, placebo-controlled pilot trial at a hand surgery department in a single academic center in adults with Dupuytren disease and an indication for needle fasciotomy. Eligible patients had a Dupuytren diathesis score greater than 4 and a nonfixed compound metacarpophalangeal and/or proximal interphalangeal contracture. Thirty patients were randomized 1:1 to receive a single 40-mg intralesional injection of adalimumab or matching saline placebo immediately after needle fasciotomy. One patient was excluded after randomization, leaving 29 patients for analysis (14 in the adalimumab group and 15 in the placebo). Fisher exact and Mann-Whitney U tests were used for categorical and continuous outcomes, respectively. Results Adalimumab did not improve the proportion of patients achieving at least a 10° improvement in TPED. At 3 months, 86% (12 of 14) of patients in the adalimumab group and 87% (13 of 15) in the placebo group achieved this improvement level, with a between-group difference in proportions of -1% (95% confidence interval [CI] -31% to 29%; p > 0.99). At 12 months, 71% (10 of 14) and 80% (12 of 15) of patients, respectively, achieved the endpoint, with a between-group difference of -9% (95% CI -41% to 24%; p = 0.68). Both groups showed no difference in change in TPED at 3 months; the median (IQR) change was -30° (-60° to -10°) versus -26° (-86° to -14°) at 3 months (Hodges-Lehmann estimate of between-group difference -4°; p = 0.76) and -32° (-60° to -5°) versus -24° (-80° to 5°) at 12 months (Hodges-Lehmann estimate of between-group difference 7°; p = 0.75). Pain and QuickDASH scores improved over time in both groups, with no between-group difference at 3 or 12 months (p > 0.05 for all). One procedure-related complication occurred; no adverse events related to either study injection were reported or observed. Conclusion A single 40-mg intralesional injection of adalimumab added to needle fasciotomy did not improve extension, TPED, pain, or QuickDASH outcomes compared with placebo at 3 or 12 months. Given the absence of detected benefit in this pilot trial, adalimumab should not be used routinely as an adjunct to needle fasciotomy outside a clinical trial. Further studies investigating repeated or higher-dose regimens, treatment at earlier disease stages, and potential combination approaches are needed to better define the therapeutic role of anti-TNF treatment and determine whether it may have a clinical application before its use in routine practice can be considered. Level of Evidence Level II, therapeutic study.