Collagenase clostridium histolyticum in patients with Dupuytren's contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes

Abstract

In POINT X, a study designed to reflect clinical practice and patient treatment choices, 254 European patients received open-label collagenase for Dupuytren's contracture. The most severely affected joint was treated first in 74% of patients. In total, 52%, 41%, 7%, and 1% of patients selected the little, ring, middle, and index finger, respectively; 79% had one or two joints treated. Only 9% of patients (n = 24) received 4 or 5 injections. The mean improvement in total passive extension deficit (TPED) was 34° on day 1, improving further by day 7 to 42°. This secondary improvement was maintained by day 90 and month 6. The mean number of injections/joint was 1.2 for the metacarpophalangeal joint and 1.25 for the proximal interphalangeal joint. Median time to recovery was 4 days; the mean improvement in hand function was clinically relevant as measured by the Unité Rhumatologique des Affections de la Main (URAM) score. In total, 87% and 86% of patients and physicians, respectively, were very satisfied or satisfied with treatment at month 6, although correlation between TPED and patient satisfaction was weak (Spearman -0.18, 95% CI -0.32 to -0.06). Collagenase was well tolerated, with 10 (3.9%) patients experiencing severe adverse events. As a real-world study, the POINT X findings can be generalized to the at-large population.

Trial registration: ClinicalTrials.gov NCT01229436.

Keywords: Collagenase; Dupuytren’s disease; efficacy; open label; patient-reported outcomes; tolerability.

Figure 1.

Patient flow.

Figure 2.

Change in ROM by joint type and time after CCH injection.* *Across all five treatment cycles. ^†Legend definitions change for these time points: 1st injection = joints that received only 1 injection; 2nd injection = joints that received 1 or 2 injections; 3rd injection = joints that received 1, 2, or 3 injections. *Across all five treatment groups. CI: confidence interval; CCH: collagenase Clostridium histolyticum; CID: clinically important difference; MP: metacarpophalangeal; PIP: proximal interphalangeal; ROM: range of motion.

Figure 3.

Changes in URAM total score by treatment cycle.* *30 days after the first injection in each treatment cycle (with ≤ 4 responses, total score was recorded as missing; with ≥ 5 responses, total score was calculated using mean score for answered items as an imputed score for missing items). Note: values inside the bars are baseline scores (pre-injection) for that cycle. CID: clinically important difference; SE: standard error; URAM: Unité Rhumatologique des Affections de la Main.

Figure 4.

Kaplan–Meier analysis of time to recovery after the first injection in cycle 1. *For patients who did not provide a response ≤ 3, the censored time to recovery was defined as the number of days between the first injection and last day within the cycle on which the patient responded to the question. CI: confidence interval.