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

Author:

Warwick D.1,Arner M.2,Pajardi G.3,Reichert B.4,Szabo Z.5,Masmejean E. H.6,Fores J.7,Chapman D. S.8,Gerber R. A.9,Huard F.10,Seghouani A.11,Szczypa P. P.12,

Affiliation:

1. National Institute of Health Research Wellcome Trust Clinical Research Facility, University Hospital Southampton, NHS Foundation Trust, UK

2. Department of Hand Surgery Södersjukhuset and Department of Clinical Science & Education, Karolinska Institutet, Stockholm, Sweden

3. San Giuseppe MultiMedica University Hospital and Università degli Studi di Milano, Milan, Italy

4. Department for Plastic, Reconstructive & Hand Surgery, Nuremberg Hospital, Nuremberg, Germany

5. Traumatology & Hand Surgery Department, BAZ University County Teaching Hospital, Miskolc, Hungary

6. Hand Surgery Unit, Georges-Pompidou European Hospital (HEGP), Assistance Publique-Hôpitaux de Paris (AP-HP), Paris-Descartes University, Sorbonne Paris Cité, Paris Cedex, France

7. Traumatología y Cirugía Ortopédica, Barcelona, Spain

8. Specialty Care Biostatistics, Pfizer Inc, New York, NY, USA

9. Medicines Development Group, Pfizer Inc, Groton, CT, USA

10. Pfizer Global Research and Development, Paris, France

11. All For Pharma, Ltd, London, UK

12. Medical Affairs, Pfizer Ltd, Tadworth Surrey, UK

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.

Publisher

SAGE Publications

Subject

Surgery

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