TY - JOUR
T1 - Collagenase clostridium histolyticum in patients with Dupuytren's contracture
T2 - Results from POINT X, an open-label study of clinical and patient-reported outcomes
AU - Warwick, D.
AU - Arner, M.
AU - Pajardi, G.
AU - Reichert, B.
AU - Szabo, Z.
AU - Masmejean, E. H.
AU - Fores, J.
AU - Chapman, D. S.
AU - Gerber, R. A.
AU - Huard, F.
AU - Seghouani, A.
AU - Szczypa, P. P.
PY - 2015/2/27
Y1 - 2015/2/27
N2 - 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.
AB - 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.
KW - Collagenase
KW - Dupuytren's disease
KW - efficacy
KW - open label
KW - patient-reported outcomes
KW - tolerability
UR - http://www.scopus.com/inward/record.url?scp=84921673550&partnerID=8YFLogxK
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U2 - 10.1177/1753193413519926
DO - 10.1177/1753193413519926
M3 - Article
C2 - 24470559
AN - SCOPUS:84921673550
SN - 1753-1934
VL - 40
SP - 124
EP - 132
JO - The Hand
JF - The Hand
IS - 2
ER -