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 degrees on day 1, improving further by day 7 to 42 degrees. 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 Unite 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.
|Titolo:||Collagenase Clostridium histolyticum in patients with Dupuytren's contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes.|
|Parole Chiave:||Collagenase; Dupuytren's disease; efficacy; tolerability; open label; patient-reported outcomes|
|Settore Scientifico Disciplinare:||Settore MED/19 - Chirurgia Plastica|
Settore MED/33 - Malattie Apparato Locomotore
|Data di pubblicazione:||feb-2015|
|Digital Object Identifier (DOI):||10.1177/1753193413519926|
|Appare nelle tipologie:||01 - Articolo su periodico|