What is the injectable drug for Dupuytren's contracture?

Injectable Treatment for Dupuytren's Contracture

Collagenase clostridium histolyticum (CCH) is the injectable drug for Dupuytren's contracture, which significantly reduces contractures and improves range of motion in affected joints with a favorable safety profile compared to surgical intervention. 1

Mechanism and Efficacy

Collagenase clostridium histolyticum works by enzymatically breaking down the collagen in the contracted cord that causes finger contractures in Dupuytren's disease. Clinical trials have demonstrated its effectiveness:

• In the CORD I and CORD II trials, 64% of cords injected with collagenase met the primary endpoint of reduction in contracture to 0-5° of full extension compared to only 6.8% with placebo 1, 2
• Range of motion in treated joints improved significantly from 43.9° to 80.7° after collagenase injection 1
• Metacarpophalangeal (MCP) joint contractures respond better than proximal interphalangeal (PIP) joint contractures 3
• Less severe contractures show better response to treatment 4

Administration Protocol

1. Dosage: 0.58 mg per injection into the contracted collagen cord 1
2. Treatment schedule: Up to three injections may be administered at 30-day intervals if needed 1
3. Manipulation procedure: One day after injection, the affected joint is manipulated to facilitate cord rupture 1, 2
4. Follow-up: Evaluation of contracture reduction occurs 30 days after the last injection 1

Clinical Outcomes

Post-approval clinical experience has shown:

• Effectiveness equivalent to or better than that observed in clinical trials 5
• Earlier-stage contractures have significantly better outcomes than later-stage contractures 5
• Success rates for different types of cords 4:
  • MCP joint cords: from 46° to 1° (mean improvement)
  • PIP joint cords: from 56° to 7° (mean improvement)
  • Natatory cords: from 130° to 25° (mean improvement)
  • Combined cords: from 102° to 16° (mean improvement)

Adverse Events

Common adverse events are generally localized and include:

• Swelling, pain, bruising, and pruritus at the injection site 1
• Transient regional lymph node enlargement and tenderness 1
• Skin splits (21% of cases), with higher risk in more severe pre-injection deformities 4

Serious adverse events are rare:

• Tendon rupture (reported in clinical trials but at lower rates in post-approval use) 1, 5
• Complex regional pain syndrome (rare) 1
• No significant changes in flexion or grip strength 1
• No systemic allergic reactions or nerve injuries reported in major trials 1

Patient Selection Considerations

CCH is particularly beneficial for:

• Patients with palpable cords causing contractures
• Those with contractures of 20° or more 1
• Patients who may not be suitable for surgical intervention
• Earlier-stage contractures, which show better response 5

Clinical Pearls

• A learning curve exists for providers administering the treatment, with fewer second injections needed as experience increases 4
• Only 4.9% of patients needed a second injection in a large post-approval study 4
• Some patients experience spontaneous cord rupture (8%) or partial spontaneous rupture (19%) before the planned manipulation procedure 4
• No recurrence of contracture was observed in the CORD II study during the follow-up period 2

CCH represents a significant advancement in the non-surgical management of Dupuytren's contracture, offering patients an effective alternative to surgery with a favorable risk-benefit profile.