Dupuytren’s contracture is a condition that affects the connective tissue that lies beneath the skin in the palm of the hand. The disease is progressive in nature. First, painful nodules develop in the palm as collagen deposits accumulate. As with typical disease progression, the collagen deposits form a cord that stretches from the palm of the hand to a joint on the finger. Once this cord develops, a Dupuytren’s patient’s finger or fingers contract and the function of the hand is impaired. The most frequently affected joints are the metacarpophalangeal joint (MP joint), which is the joint closest to the palm of the hand, and the proximal interphalangeal joint (PIP joint), which is the middle joint in the finger. The little finger and ring finger are most frequently involved. Surgery is the only treatment proven effective at present; however, there exists the possibility for a prolonged recovery period and high recurrence rates.

The incidence of Dupuytren's contracture is highest in Caucasians, historically those of Northern European descent. Most cases of Dupuytren's contracture occur in men older than 50 years, and the incidence increases with age. It is common for the disease to affect both hands, and recurrence of disease is common once treated surgically. Xiaflex is injected intralesionally into the affected area in an in-office procedure to soften and ultimately lyse the cord.

Clinical Trial Results

The first phase III study, sponsored and monitored by BioSpecifics Technologies Corp., licensor of Xiaflex, with follow up and data analysis conducted by Auxilium, showed promising results. The trial involved a total of 35 patients, 23 of whom were randomized to receive up to three injections of Xiaflex and 12 patients who were randomized to receive placebo. Xiaflex achieved a 91% success rate for the primary endpoint of less than 5° of contracture in treated joints, including both PIP joints and MP joints, after up to three injections. The placebo group had a 0% response rate (P < 0.001). The mean number of injections per joint was 1.4. The results observed after a single injection of Xiaflex showed that 70% of subjects achieved therapeutic success (contracture reduced to 5° or less); no patients responded to placebo (P < 0.001). These phase III results were consistent with those from a phase II study published in The Journal of Hand Surgery (2002;27A:788-798).