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Introduction: Collagenase clostridium histolyticum (CCH, Xiaflex^®) is an enzymatic treatment for adult patients with Dupuytren’s contracture (DC) with a palpable cord. This analysis is part of an ongoing 5-year prospective, observational study following subjects treated with CCH in phase 3 trials. At 3 years, this study found that 65% of all joints corrected to 0°-5° maintained the correction and 93% of all successfully treated joints did not have additional surgical/medical treatment. This analysis examines factors that may be associated with recurrence/extension of disease.

Materials & Methods: Subjects received ≥1 CCH injection in a phase 3 trial and had at least a Year 2 follow-up visit. At yearly follow-up visits, fixed flexion contracture (FFC) was measured for every treated and untreated joint. Recurrence was defined as any treated joint with FFC increase ≥20° and a palpable cord or having medical/surgical treatment. Extension was defined as any untreated joint with FFC increase ≥20° with a palpable cord or having medical/surgical treatment. A recurrent subject had at least one recurrent joint; subjects with extension of disease had at least one joint with extension. Unadjusted odds ratio (OR) for extension and recurrence of disease with 95% confidence interval were computed for all predictor variables. Wald chi-square was used to calculate p values.

Results: We identified 643 eligible subjects (1080 treated joints); 94% of subjects had a 3-year assessment. Mean (SD) follow-up was 1100 (99.4) days from first CCH injection; 49% of subjects had recurrence on ≥1 joint and 39% had developed FFC on an untreated joint. Several variables had a significant OR of developing recurrent DC: bilateral disease (p<.001), baseline total contracture index (TCI) measurement >110° (p<.001), family history of DC (p=.003), epilepsy (p=.02), history of hand trauma (p=.04), alcohol consumption (p=.02), age <65 years old (p=0.02), and weight less than median for their gender (p=.05). A significant OR of developing extension DC in an untreated joint was associated with bilateral disease (p<.001), baseline TCI measurement >110° (p<.001), age <65 years old (p=.02), and weight less than the median for their gender (p=0.01).

Conclusions: We found several factors associated with DC recurrence and extension after CCH injection including: bilateral disease, high TCI, and age <65 years, all of which are surrogate measures for disease severity. This study suggests that the likelihood of a subject having recurrence or worsening of their DC can be best predicted with knowledge of a few subject and disease characteristics.