Manuscript appears in a peer-reviewed journal for the first time
- The Phase 4 retrospective study evaluates previously generated XIAFLEX® (collagenase clostridium histolyticum) data for recurrent Dupuytren contracture after surgery.
- Findings suggest XIAFLEX may offer an alternative to repeat surgery and add to existing insights on recurrence management.
- Keenova uses research to help strengthen clinical resources to support providers and patient care.
DUBLIN, March 3, 2026 /PRNewswire/ -- Keenova Therapeutics plc announced the first-time publication of a retrospective analysis using previously generated XIAFLEX® (collagenase clostridium histolyticum) data. The analysis evaluates treatment of Dupuytren contracture (DC) recurrence after surgical correction. The manuscript appears in the peer-reviewed Journal of Hand Surgery Global Online, available here.
Why It Matters
DC can return after any treatment, leaving patients and providers unsure about next steps. Keenova supports research that expands the evidence base and helps hand specialists understand how nonsurgical XIAFLEX may fit into recurrence management. This work advances Keenova's commitment to advancing disease awareness and improving support for both providers and patients.
The News
- The analysis evaluated XIAFLEX in patients who experienced recurrence at least six months after a previously successful surgery.
- Adverse events were consistent with prior reports of collagenase clostridium histolyticum (CCH) in patients without prior surgical treatment.
- The Phase 4 multicenter, noninterventional retrospective review analyzed medical records from 10 U.S. clinical centers.
- The review included patients who experienced recurrence at least six months after a successful surgical correction and received collagenase treatment between January 2010 and August 2020.
- Primary endpoints measured changes in joint contracture within 12 months of treatment.
- Secondary endpoints assessed "clinical success," defined as the percentage of joints with reduction in contracture to 0° to 5°, and adverse events.
Expert Perspective
"These findings may help healthcare providers better manage Dupuytren contracture recurrence in patients despite an initially successful surgery," said Clayton A. Peimer, MD, Adjunct Clinical Professor of Orthopedics at the Warren Alpert Medical School of Brown University and lead author. "In these situations, collagenase offers an effective nonsurgical alternative to repeat operative treatment. Our study adds important insight into the available options for recurrent Dupuytren contracture and supports improved choices and outcomes for patients."
Manuscript Details
- Title: Treatment of Dupuytren Contracture Recurrence After Surgery with Collagenase Clostridium Histolyticum: A Retrospective Multicenter Series
- Authors: Clayton A. Peimer, MD; Marie A. Badalamente, PhD; Philip Blazar, MD; Keith A. Denkler, MD; William Dzwierzynski, MD; Mark Elzik, MD; F. Thomas D. Kaplan, MD; Jason A. Nydick, DO; Gary M. Pess, MD; James Verheyden, MD; Mark A. Vitale, MD; Jeffrey Andrews, MS; Qinfang Xiang, PhD; David Hurley, MD; Lawrence C. Hurst, MD.
About Dupuytren Contracture
Dupuytren contracture is a lifelong condition that may get worse over time. It's caused by a buildup of collagen in the hand, which forms a rope-like cord that pulls fingers toward the palm so they can't be straightened. As Dupuytren's contracture progresses, it may become difficult for individuals to use their hand(s) for daily tasks and activities.1,2 Dupuytren contracture affects an estimated 13 million Americans.3,4*
INDICATION
XIAFLEX is indicated for the treatment of adult patients with Dupuytren's contracture with a palpable cord.
IMPORTANT SAFETY INFORMATION
- XIAFLEX is contraindicated in patients with a history of hypersensitivity to XIAFLEX or to collagenase used in any other therapeutic application or application method
- In the controlled and uncontrolled portions of clinical trials in Dupuytren's contracture, flexor tendon ruptures occurred after XIAFLEX injection. Injection of XIAFLEX into collagen-containing structures such as tendons or ligaments of the hand may result in damage to those structures and possible permanent injury such as tendon rupture or ligament damage. Therefore, XIAFLEX should be injected only into the collagen cord with a metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint contracture, and care should be taken to avoid injecting into tendons, nerves, blood vessels, or other collagen-containing structures of the hand. When injecting a cord affecting a PIP joint of the fifth finger, the needle insertion should not be more than 2 to 3 mm in depth and avoid injecting more than 4 mm distal to the palmar digital crease
- Other XIAFLEX-associated serious local adverse reactions in the controlled and uncontrolled portions of the clinical studies included pulley rupture, ligament injury, complex regional pain syndrome (CRPS), sensory abnormality of the hand, and skin laceration (tear). In a historically controlled post-marketing trial, the incidence of skin laceration (22%) was higher for subjects treated with two concurrent injections of XIAFLEX compared with subjects treated with up to three single injections in the placebo-controlled premarketing trials (9%). Post-marketing cases of skin laceration requiring skin graft after finger extension procedures and local skin and soft-tissue necrosis, some requiring skin grafting, or other surgical interventions including finger amputation have been reported. Signs or symptoms that may reflect serious injury to the injected finger/hand should be promptly evaluated because surgical intervention may be required
- Cases of syncope and presyncope have been reported in the post-marketing period in patients treated with XIAFLEX. In most cases in patients with Dupuytren's contracture, the injection procedure, finger extension procedure, or pain following the procedures were reported as potential triggers for the events, suggesting a vasovagal mechanism. Most, but not all, cases occurred in the immediate treatment period (injection or finger extension procedure) or within 1 to 2 days following the injection or finger extension procedure. If presyncopal symptoms occur, patients should remain recumbent until symptoms resolve. Syncope may be associated with bodily injuries, including concussion, head abrasion, and other accidental injuries
- In the controlled portions of the clinical trials in Dupuytren's contracture, a greater proportion of XIAFLEX-treated patients (15%) compared to placebo-treated patients (1%) had mild allergic reactions (pruritus) after up to 3 injections. The incidence of XIAFLEX-associated pruritus increased after more XIAFLEX injections in patients with Dupuytren's contracture
- Because XIAFLEX contains foreign proteins, severe allergic reactions to XIAFLEX can occur. Anaphylaxis was reported in a post-marketing clinical trial in one patient who had previous exposure to XIAFLEX for the treatment of Dupuytren's contracture. Healthcare providers should be prepared to address severe allergic reactions following XIAFLEX injections
- In the XIAFLEX trials in Dupuytren's contracture, 70% and 38% of XIAFLEX-treated patients developed an ecchymosis/contusion or an injection site hemorrhage, respectively. Patients with abnormal coagulation (except for patients taking low-dose aspirin, eg, up to 150 mg per day) were excluded from participating in these studies. Therefore, the efficacy and safety of XIAFLEX in patients receiving anticoagulant medications (other than low-dose aspirin, eg, up to 150 mg per day) within 7 days prior to XIAFLEX administration is not known. In addition, it is recommended to avoid use of XIAFLEX in patients with coagulation disorders, including patients receiving concomitant anticoagulants (except for low-dose aspirin)
- In the XIAFLEX clinical trials for Dupuytren's contracture, the most common adverse reactions reported in ≥25% of patients treated with XIAFLEX and at an incidence greater than placebo were edema peripheral (eg, swelling of the injected hand), contusion, injection site hemorrhage, injection site reaction, and pain in the injected extremity.
- Post-marketing experience - Syncope and presyncope have been reported in patients treated with XIAFLEX. Most, but not all, cases occurred in the immediate treatment period or within 1 to 2 days following injection. Bodily injuries associated with the syncopal events have been reported
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About Keenova
Keenova Therapeutics is a leading global developer and manufacturer of branded therapeutics that strives to help patients with rare or unaddressed conditions live happier and healthier lives.
The Company's diversified brands portfolio is focused across a wide range of therapeutic areas of significant unmet need, including endocrinology, gastroenterology, hepatology, immunology, neonatal respiratory critical care, nephrology, neurology, pulmonology, ophthalmology, orthopedics, rheumatology and urology. Globally headquartered in Dublin, Ireland, Keenova benefits from a strong U.S. manufacturing footprint with facilities in Louisiana, New Jersey, New York, Pennsylvania and Wisconsin. To learn more, please visit www.keenova.com.
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* Dupuytren Contracture prevalence estimation calculation in the U.S.: Average Dupuytren contracture prevalence in the U.S. (5%) multiplied by U.S. adult population (~258 million adults per 2020 U.S. Census data) = ~13 million.
References
- Hurst, LC, Badalamente, MA, et al. New England Journal of Medicine.2009;361(10),968-979.
- Bayat, A, McGrouther, DA. Annals of the Royal College of Surgeons of England. 2006;88(1),3-8.
- "How common is Dupuytren disease?" Dupuytren Research Group. April 1, 2017. Accessed February 2, 2026. https://dupuytrens.org/faq
- "U.S. and world population clock." U.S. Census Bureau. Updated April 13, 2023. Accessed February 2, 2026. https://www.census.gov/popclock
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