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Collagenase clostridium histolyticum in patients with Dupuytren’s contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes
- Source :
- The Journal of Hand Surgery, European Volume, Warwick, D, Arner, M, Pajardi, G, Reichert, B, Szabo, Z, Masmejean, E H, Fores, J, Chapman, D S, Gerber, R A, Huard, F, Seghouani, A, Szczypa, P P & POINT X Investigators 2015, ' 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-British and European Volume, vol. 40, no. 2, pp. 124-32 . https://doi.org/10.1177/1753193413519926, Journal of Hand Surgery (European Volume), Journal of Hand Surgery (European Volume), SAGE Publishing, 2015, 40 (2), pp.124-132. ⟨10.1177/1753193413519926⟩
- Publication Year :
- 2014
- Publisher :
- SAGE Publications, 2014.
-
Abstract
- International audience; 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.
- Subjects :
- Male
medicine.medical_specialty
Clinical Trial, Phase III
Collagenase
efficacy
Population
[SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/Surgery
Injections, Intralesional
Dupuytren’s disease
Patient satisfaction
Collagenase clostridium histolyticum
Journal Article
medicine
Humans
tolerability
Dupuytren's contracture
education
Aged
education.field_of_study
business.industry
Research Support, Non-U.S. Gov't
open label
Metacarpophalangeal joint
Middle Aged
medicine.disease
3. Good health
Surgery
Dupuytren Contracture
Patient Outcome Assessment
Microbial Collagenase
medicine.anatomical_structure
Tolerability
Patient Satisfaction
patient-reported outcomes
Female
Full Length Articles
Contracture
medicine.symptom
business
Interphalangeal Joint
medicine.drug
Subjects
Details
- ISSN :
- 20436289 and 17531934
- Volume :
- 40
- Database :
- OpenAIRE
- Journal :
- Journal of Hand Surgery (European Volume)
- Accession number :
- edsair.doi.dedup.....3816ae778d6afa1b69fd7e6164fcb8e9
- Full Text :
- https://doi.org/10.1177/1753193413519926