Collagenase clostridium histolyticum in patients with Dupuytren’s contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes - Université de Montpellier Accéder directement au contenu
Article Dans Une Revue Journal of Hand Surgery (European Volume) Année : 2015

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

D. Warwick
  • Fonction : Auteur
M. Arner
  • Fonction : Auteur
G. Pajardi
  • Fonction : Auteur
B. Reichert
  • Fonction : Auteur
Z. Szabo
  • Fonction : Auteur
J. Fores
  • Fonction : Auteur
D. Chapman
  • Fonction : Auteur
R. Gerber
  • Fonction : Auteur
F. Huard
  • Fonction : Auteur
A. Seghouani
  • Fonction : Auteur
P. Szczypa
  • Fonction : Auteur
Point X Investigators
  • Fonction : Auteur

Résumé

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.

Domaines

Chirurgie

Dates et versions

hal-02279805 , version 1 (05-09-2019)

Identifiants

Citer

D. Warwick, M. Arner, G. Pajardi, B. Reichert, Z. Szabo, et al.. Collagenase clostridium histolyticum in patients with Dupuytren’s contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes. Journal of Hand Surgery (European Volume), 2015, 40 (2), pp.124-132. ⟨10.1177/1753193413519926⟩. ⟨hal-02279805⟩
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