Auxilium Pharmaceuticals announced positive top-line data from its open-label phase 3b trial evaluating Xiaflex (collagenase clostridium histolyticum) for the treatment of adult Dupuytren’s contracture patients with multiple palpable cords.
This phase 3b study was an open-label study that was designed to assess the safety and efficacy of concurrent administration of two injections of Xiaflex into the same hand of subjects with at least two Dupuytren’s contractures caused by palpable cords. Multiple combinations of concurrent cords were treated in the trial: patients with two metacarpophalangeal (MP) joints in different fingers, patients with two PIP cords in different fingers, patients with 1 MP cord and 1 PIP cord in different fingers, and patients with 1 MP cord and 1 PIP cord in the same finger. Efficacy assessments included measuring finger goniometry and range of motion of the treated joints on Days 1, 8, 30, and 60, following the first cycle of two injections. Upon completion of the day 60 follow-up visit following the first treatment cycle, subjects who required additional treatment in the treated hand were allowed to receive Xiaflex in other individual cords, up to a total of five total injections.
In this study, 60 patients received two concurrent injections of 0.58mg of Xiaflex per affected hand. At 30 days, 60% of all joints, 76% of MP and 33% proximal interphalangeal joints achieved clinical success (defined as joint correction to 0–5 degrees) following this single injection when two 0.58mg doses of Xiaflex were administered concurrently into the same hand. These response rates are numerically higher than the response rates seen after the first single injection in the double-blind placebo controlled Phase 3 studies.
Xiaflex contains a mixture of collagenase proteins that hydrolyze collagen in its native triple helical conformation under physiological conditions, resulting in lysis of collagen deposits. Xiaflex is currently indicated for the treatment of adult patients with Dupuytren’s contracture with a palpable cord.
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