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

被引:38
作者
Warwick, D.
Arner, M. [1 ,2 ]
Pajardi, G. [3 ,4 ]
Reichert, B. [5 ]
Szabo, Z. [6 ]
Masmejean, E. H. [7 ]
Fores, J.
Chapman, D. S. [8 ]
Gerber, R. A. [9 ]
Huard, F. [10 ]
Seghouani, A. [11 ]
Szczypa, P. P. [12 ]
机构
[1] Karolinska Inst, Dept Hand Surg Sodersjukhuset, Stockholm, Sweden
[2] Karolinska Inst, Dept Clin Sci Educ, Stockholm, Sweden
[3] San Giuseppe MultiMed Univ Hosp, Milan, Italy
[4] Univ Milan, Milan, Italy
[5] Nuremberg Hosp, Dept Plast Reconstruct & Hand Surg, Nurnberg, Germany
[6] BAZ Univ Cty Teaching Hosp, Traumatol & Hand Surg Dept, Miskolc, Hungary
[7] Paris Descartes Univ, Georges Pompidou European Hosp HEGP, AP HP, Hand Surg Unit,Sorbonne Paris Cite, Paris, France
[8] Pfizer Inc, Specialty Care Biostat, New York, NY USA
[9] Pfizer Inc, Med Dev Grp, Groton, CT 06340 USA
[10] Pfizer Global Res & Dev, Paris, France
[11] All Pharma Ltd, London, England
[12] Pfizer Ltd, Med Affairs, Tadworth, Surrey, England
关键词
Collagenase; Dupuytren's disease; efficacy; tolerability; open label; patient-reported outcomes; PERCUTANEOUS NEEDLE FASCIOTOMY; DISEASE; EFFICACY; SAFETY;
D O I
10.1177/1753193413519926
中图分类号
R826.8 [整形外科学]; R782.2 [口腔颌面部整形外科学]; R726.2 [小儿整形外科学]; R62 [整形外科学(修复外科学)];
学科分类号
摘要
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.
引用
收藏
页码:124 / 132
页数:9
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