Endo International plc Presents New Investigational Collagenase Clostridium Histolyticum Survey Data at American Society for Surgery of the Hand Annual Meeting
September 30, 2021 at 11:08 am EDT
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Endo International plc announced results from the first two rounds of Delphi research exploring the expert positions of hand surgeons on the appropriate treatment of Dupuytren's disease (DD) with collagenase clostridium histolyticum (CCH) in patients with varying degrees of disease severity and functional impairment. The data are being presented on an e-poster at the American Society for Surgery of the Hand (ASSH) Annual Meeting in San Francisco, September 30–October 2. Dupuytren's disease is a heterogenous fibroproliferative condition of the palmar fascia characterized by the development of fascial nodules and cords that may result in digital contracture affecting hand function. XIAFLEX® (collagenase clostridium histolyticum) is a nonsurgical treatment option composed of two purified collagenases that work to break down collagen when injected into fibrous tissue. Researchers used a modified Delphi method employing three successive online survey rounds to capture the clinical expertise of panelists and determine if consensus could be reached regarding the use of CCH for the treatment of DD. In Round 1, 22 real-world case scenarios were used to determine the panelists' recommendations for using CCH to treat metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joint contractures involving a single finger or 2 fingers, with varying degrees of contracture and clinical severity. Each scenario presented a distinct contracture(s) with a series of statements to evaluate the impact of patient- or disease-related features (ie, age, recurrence, risk of anesthesia, diathesis, poor-quality skin, post-fasciectomy scarring) on the clinical decision to use CCH. Appropriate use of CCH for the treatment of thumb contractures and in patients who are on blood thinners other than aspirin also were explored. Researchers captured responses using a 5-point Likert scale ("strongly agree," "agree," "deficient information," "disagree," and "strongly disagree"). Level of agreement for each statement was determined, with a consensus threshold of =66.7% for agreement ("strongly agree" and "agree") or disagreement ("strongly disagree" and "disagree"). Of the 33 hand surgeons who were invited based on their expertise in DD, 22 agreed to participate in the survey, 20 of whom completed Round 1 of the survey; 19 completed Round 2. Overall, 80% had practiced medicine for at least 15 years and all had completed a fellowship in hand surgery. 90% were added qualification [CAQ]-certified hand surgeons. Consensus data from Rounds 1 and 2 indicated a high level of consensus for using CCH for the treatment of MP joint contractures of varying severity and in patients with MP and/or interphalangeal thumb contractures. Additional contextual data in Round 2 helped achieve consensus for using CCH for treating PIP joint contractures of varying severities. Statements not achieving consensus are being explored in Round 3. Consensus-based findings among expert hand surgeons point to wide-ranging application of CCH for the treatment of DD for patients with varying degrees of disease severity and functional impairment.
Endo International plc is a specialty pharmaceutical company. The Company operates through four business segments: Branded Pharmaceuticals, Sterile Injectables, Generic Pharmaceuticals and International Pharmaceuticals. Its Branded Pharmaceuticals segment includes a variety of branded products in the areas of urology, orthopedics, endocrinology, medical aesthetics and bariatrics, among others. Its products include XIAFLEX, SUPPRELIN LA, NASCOBAL Nasal Spray, AVEED, QWO, PERCOCET, TESTOPEL and EDEX, among others. Its Sterile Injectables segment consists of branded sterile injectable products such as VASOSTRICT, ADRENALIN and APLISOL, among others, and certain generic sterile injectable products, including ertapenem for injection and ephedrine sulfate injection, among others. The Companyâs Generic Pharmaceuticals segment consists of a product portfolio including solid oral extended-release, solid oral immediate-release, liquids, semi-solids, patches, powders, ophthalmics and sprays.
Endo International plc Presents New Investigational Collagenase Clostridium Histolyticum Survey Data at American Society for Surgery of the Hand Annual Meeting