Collagenase clostridium histolyticum in patients with Dupuytren's contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes.
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.
National Institute of Health Research Wellcome Trust Clinical Research Facility, University Hospital Southampton, NHS Foundation Trust, UK davidwarwick@handsurgery.co.uk.
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Warwick
Department of Hand Surgery Södersjukhuset and Department of Clinical Science & Education, Karolinska Institutet, Stockholm, Sweden.
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Arner
San Giuseppe MultiMedica University Hospital and Università degli Studi di Milano, Milan, Italy.
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Pajardi
Department for Plastic, Reconstructive & Hand Surgery, Nuremberg Hospital, Nuremberg, Germany.
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Reichert
Traumatology & Hand Surgery Department, BAZ University County Teaching Hospital, Miskolc, Hungary.
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Szabo
Hand Surgery Unit, Georges-Pompidou European Hospital (HEGP), Assistance Publique-Hôpitaux de Paris (AP-HP), Paris-Descartes University, Sorbonne Paris Cité, Paris Cedex, France.
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Masmejean
Traumatología y Cirugía Ortopédica, Barcelona, Spain.
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Fores
Specialty Care Biostatistics, Pfizer Inc, New York, NY, USA.
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Chapman
Medicines Development Group, Pfizer Inc, Groton, CT, USA.
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Gerber
Pfizer Global Research and Development, Paris, France.
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Huard
All For Pharma, Ltd, London, UK.
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Seghouani
Medical Affairs, Pfizer Ltd, Tadworth Surrey, UK.
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Szczypa
D000368:Aged; D004387:Dupuytren Contracture / Q000188:drug therapy*; D005260:Female; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D003012:Microbial Collagenase / Q000008:administration & dosage*; D008875:Middle Aged; D063868:Patient Outcome Assessment; D017060:Patient Satisfaction
D003012:Microbial Collagenase
Collagenase; Dupuytren’s disease; efficacy; open label; patient-reported outcomes; tolerability