Efficacy

Proven efficacy in Dupuytren’s treatment

sustained efficacy rate

 

Xiapex has proven efficacy in the treatment of Dupuytren's contracture. Its efficacy is supported by data gathered from CORD I and CORD II.1,2 These are the largest prospective, placebo-controlled studies conducted in patients with Dupuytren’s disease to date.

The result of CORD I showed that Xiapex reduced the degree of contracture to 5 degrees or less, approximately 30 days after the last injection of the joint, in 64% of the 308 enrolled patients. This compared with the 6.8% of those injected with placebo (P < 0.001).1 Similar results were seen in CORD II (44.4 % vs 4.8 %; p<0.001).2

 

Reduced joint contracture

Xiapex shows a significantly reduction in joint contracture vs placebo

Xiapex has proven efficiacy in the treatment of Dupuytren's contracture. This efficacy is supported by data gathered from CORD I and CORD II.1,2

Significant reduction in joint contracture to 0 to 5 degrees of normal extension with Xiapex vs placebo1,2

Image

 

Improved range of motion

Xiapex improves range of motion1,2

In CORD I and CORD II, range of motion (ROM) was defined as the difference between the full flexion angle and full extension angle, expressed in degrees.1,2

In CORD I (n=308), Xiapex showed a significant improvement in range of motion compared with placebo.1

Improvement in MP joint range of motion in CORD I

 

Xiapex improves range of motion

 

Xiapex showed a 29 degree mean improvement in range of motion in PIP joints (p<0.001).Improvements in range of motion of ≥13.5 degrees are deemed clinically relevant.

Improved range of motion was correlated with greater patient satisfaction (r=0.51, p<0.001).3

 

You can treat two cords in one session

Multicord Study design4

Multicenter, open-label phase 3b study

Primary endpoint:

  • Safety of two concurrent injections of Xiapex into the same hand in subjects with multiple Dupuytren’s contractures with palpable cords
  • Followed 24 to 72 hours later by a finger extension procedure

    Secondary endpoint:

    • Evaluate the efficacy of two concurrent injections of Xiapex
    CONCLUSION

    Xiapex can be used to treat 2 affected joints concurrently without a greater risk of side effects than treatment of a single joint, with the exception of skin laceration.

     

    Improvement in fixed flexion contracture regardless of extension day4

     

    contracture regardless of extension day

     

    Similar safety profile as with treatment of one cord3,4*

     

    Similar safety profile as with treatment of one cord

     

    More safety details may be found here.

     

    High patient satisfaction

    Patients demonstrate a high level of satisfaction when treated with Xiapex3

    Based on a global assessment of treatment satisfaction, more than 85 % of patients receiving Xiapex in the CORD I and CORD II studies reported being “very satisfied” or quite satisfied”.

    Greater patient satisfaction was correlated with improved range of motion.
    r = 0.51, p< 0.001).

    85%
    Patient satisfaction

     

     

    Efficacy over time

    Durability of response to Xiapex demonstrated in Phase III clinical trails5

    The long-term extension trial (CORDLESS) is a prospective 5 year trial examining the recurrence and long-term safety with annual interim analyses.

    Recurrence was defined as:

    • Contracture increased by ≥ 20o with palpable cord OR
    • Medical/surgical intervention performed (i.e. if surgery/reinjection later performed)
    The rate of increase of recurrence appears to have slowed over time5
    over time graf

     

    No new safety signals were identified among subjects who were followed for 5 years after their initial injection of Xiapex.

    Retreatment

    Can treated joints be retreated?

    To find out whether treated contractures can be retreated, patients from an earlier study called CORDLESS were included in an open-label phase 4 study. The patients had recurrence of contracture and a palpable cord in a joint that had been previously effectively treated.

    Yes, previously treated contractures can be successfully retreated6

    Percentage of patients with reduction in joint contracture to 0 to 5 degrees

     Percentage of patients with reduction in joint degrees

     

     

    References:

    1. Hurst LC et al. N Engl J Med. 2009;361:968–979
    2. Gilpin D et al. J Hand Surg. 2010;35A:2027–2038
    3. Xiapex Summary of Product Characteristics.
    4. Gaston G, et al. J Hand Surg Am. 2015;40(10):1963-71
    5. Peimer CA et al. J Hand Surg Am. 2015 Aug;40(8):1597-605.
    6. Bear BJ et al. Hand Surg Am. 2017 May;42(5):391.e1-391.e8.