Participant Satisfaction and Investigator Assessment of Collagenase Clostridium Histolyticum Injection as a Nonsurgical Intralesional Treatment Option for Plantar Fibromatosis

Abstract

Category: Midfoot/Forefoot; Basic Sciences/Biologics Introduction/Purpose: Currently, there is no safe and efficacious injectable therapy for symptomatic plantar fibromatosis (PFi) that addresses its pathophysiology. Patients with PFi nodules experience symptoms that reduce quality of life, causing functional disability leading to severe impairment in some patients. Collagenase clostridium histolyticum (CCH) is approved for Dupuytren’s and Peyronie’s disease treatment, which are both fibroproliferative disorders that may coexist in patients with PFi. This first study of CCH treatment for PFi evaluated participant satisfaction and investigator assessment of improvement. Methods: Participants were randomly allocated (1:1:1) in this Phase 1, multicenter study to receive 0.6, 1.2, or 2.25 mg/mL CCH. All participants underwent the initial treatment period (ITP) and received 1–2 intralesional injections per nodule on Day 1 with follow-up assessments at specified intervals. Participants with palpable treated nodules could enter the retreatment period (RP) and receive additional CCH doses (at 2.25 mg/mL), with follow-up at specified intervals. Assessments included the Subject Satisfaction with Treatment Rating Scale (+2: very satisfied; to -2: very dissatisfied), and the Investigator Assessment of Improvement Scale (+3: very much improvement; to -3: very much worse). Results: After ITP, ≥75% of participants reported “very” or “quite” satisfied across all treatment groups, with 2.25 mg/mL group reporting 100% satisfaction. For ≥72.7% of nodules, participants reported satisfaction with outcome. Investigators reported improvement (“minimal”, “much”, or “very much”) in ≥75% of participants and ≥80% of treated nodules. After RP, 63.6% of participants reported treatment satisfaction; participants were satisfied with 66.7% of treated nodules, indicating continued improvement from the ITP. Almost all participants (90.9%) were deemed by investigators to have shown improvement, with 86.7% of treated nodules being assessed as having improvement. Conclusion: CCH-treated PFi participants were satisfied with their improvement; physicians assessed improvement in >90% of participants. Results indicate CCH as a potential nonsurgical intralesional option for PFi treatment.