David Warwick s Collagenase Information Sheet

Transcription

1 Professor David Warwick MD FRCS FRCS(Orth) European Diploma of Hand Surgery David Warwick s Collagenase Information Sheet WHAT IS COLLAGENASE? Xiapex is the trade name of collagenase clostridium hystiolyticum which is produced naturally from a bacterium called clostridium histolyticum. The drug was produced after many years of research leading to a clinical research programme which proved its effectiveness. The drug specifically dissolves the collagen contained within a cord of Duputyren s Disease. This removes a segment of the cord. Once the segment is removed, the cord no longer tethers down the finger and so the finger can straighten. Until now, only surgery or needle puncture could achieve this. Xiapex can be considered as a surgical drug In 2010 it was given approval by the FDA (Federal Drugs Administration) in the USA; in 2011, it was given approval by the European Medicines Agency and then by the UK. The evidence which led to the approval by the FDA and European Medicines Agency can be seen below: David Warwick has published further studies in 2015 to confirm the efficacy. Click on the hyperlink to see the results Warwick DJ, Graham D, Worsley P (2015) New insights into the immediate outcome of collagenase injections for Dupuytren's contracture. J Hand Surg Eur Vol Aug 25. pii: [Epub ahead of print] Warwick D et al (2015) Collagenase clostridium histolyticum in patients with Dupuytren's contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes.. J Hand Surg Eur Vol Feb;40(2): doi: / Epub 2014 Jan 26.

2 WHAT ARE THE CHANCES OF BEING SATISFIED? In 587 patients given Xiapex, most patients (92%) were very satisfied (71%) or quite satisfied (21%) with treatment. Witthaut J et al (2013) Efficacy and Safety of Collagenase Clostridium Histolyticum Injection for Dupuytren Contracture: Short-Term Results From 2 Open-Label Studies J Hand Surg 2013;38A: In 280 patients given Xiapex in nth Europe wide study published by David Warwick in 2015, the satisfaction rate was 87% at 6 months. David Warwick has surveyed his patients for satisfaction in Results overall satisfaction n=213! Warwick D, Bradley J data on file 50.0% Willingness to have CCH again! Warwick D, Bradley J data on file 45.0% 50.0% 45.0% 40.0% Participants (%) 35.0% 30.0% 25.0% 20.0% 15.0% Participants (%) 40.0% 35.0% 30.0% 25.0% 20.0% 15.0% 10.0% 10.0% 5.0% 5.0% 0.0% Very Unsatisfied Somewhat Unsatisfied Neither atisfied or unsatisfied Somewhat satisfied Very Satisfied Series1 10.8% 9.9% 6.6% 28.6% 44.1% 0.0% Definitely not Probably not Unsure whether would or would not Probably would Definitely would Series1 10.0% 6.7% 9.0% 28.6% 45.7% Results preference to surgery! n=78/ of 212 (36.8%) who answered the question had had previous surgery on their hands for Dupuytren s Disease. Participant preference for Xiapex over surgery! Definitely! Probably! Not sure! Probably not! Definitely not! Percentage! 46%! 24%! 14%! 8%! 8%! Warwick D, Bradley J data on file

3 W HAT ARE THE CHANCES O F THE DISEASE CO MING BACK? What we know-recurrence! The latest research shows that the chance of recurrence is high as the years go by especially in years years 4 years 5 years Overall (n=623) MP Joints (n=451) PIP Joints (n=172) Peimer C, Blazar P, Coleman S, Kaplan T, Smith T, Lindau T. Dupuytren Contracture Recurrence Following Treatment With Collagenase Clostridium Histolyticum (CORDLESS [Collagenase Option for Reduction of Dupuytren Long-Term Evaluation of Safety Study]): 5Year Data. J Hand Surg (Am) 2015;40: the PIP joint. This means that the disease is quite likely to recur over time and if so satisfaction may decline. Treatment should be straightforward though, with another simple injection or if the disease is too troublesome then standard surgery. D AVID W ARW ICK S P ERSO NAL R ESULTS See the RESULTS tab on the website W HAT H APPENS W HEN I HAVE X IAPEX? You are assessed in the clinic by Professor Warwick to ensure you are suitable. The deformity of your fingers is measured and you are asked to fill out two brief questionnaires to assess your function. On the day of the injection, you are asked to sign a consent form (downloadable in advance). The Xiapex is removed from the Pharmacy fridge an hour before the injection and warms up to room temperature. The two vials (fluid and powder)

4 and then gently mixed. Your hand is sterilised with alcohol and the Xiapex is injected into the cord with a very fine needle. A cold spray is used to minimise the discomfort. A dressing is applied. Overnight, your hand may get quite bruised and swollen that is normal and sometimes quite alarming. On a convenient day within 7 days of the injection you come back for the manipulation. You come back to the clinic. Your hand is sterilised again with alcohol. Local anaesthetic is injected around the cord a(which can be quite sore) and then the cord is gently manipulated into extension until it snaps. C AN I D RIVE OR W O RK AFTER THE I NJECTIO N? You should not drive after the injection or manipulation until you feel safe to control the car in all eventualities. Choosing to drive is your own responsibility and not the Doctor s. However, most people can drive within a few days. With regards to return to work, the mean return to work is 4 days (Warwick et al 2015). This compares with 4 to 6 weeks for clerical work and 9 weeks for manual work with surgery. (Tonkin MA, Burke FD, Varian JPW (1984) Dupuytren's Contracture: A Comparative Study of Fasciectomy and Dermofasciectomy in One Hundred Patients. Journal of Hand Surgery 9: 156) W HAT ARE THE C O STS? Insured patients: The insurance companies have applied a code to Xiapex injection: T7440, AC100 Injection into cord for Dupuytren s Contracture, W9240- manipulation under local anaesthetic Self funding patients: At the Wessex Nuffield Hospital, there is a fixed price option (currently 1850) to cover the cost of a Xiapex injection including the drug, hospital tariff, surgeon s fee and splint. If the injection does not work first time, then you would need to pay for the second at a similar rate. An initial consultation with Professor Warwick to see whether you are suitable is 180. A RE THERE R ISKS? David Warwick s personal complication rates are published on the Results Tab ( There are two potential very serious, but very rare, problems: Allergic reaction: About 17% of people may have a mild allergic reaction itching or a rash. The armpit nodes may become sore and swollen. There is a theoretical risk of anaphylactic shock (ie sudden collapse with airway obstruction and circulatory collapse). This is exceedingly unlikely and has never been reported with the drug. Nevertheless, Adrenaline (the antidote to this) is kept immediately available when the drug is given. Tendon rupture: Collagenase will damage tendons if inadvertently injected too deeply. For this reason, it is only administered by trained hand surgeons. In the

5 extremely unlikely event that you find that you cannot bend the finger after the injection, let Mr Warwick know. According to the data sheet, the following are risks: Very common side effects, affects more than 1 user in 10 Reactions at the injection site like bleeding, pain, swelling, tenderness and bruising. Itching in the hand. Feeling of pain in the hand, wrist or arm. Swollen or enlarged glands near the elbow or under the arm. Swelling in the hand or arm. Common side effects, affects 1 to 10 in 100 Reactions at the injection site like pain, warmth, swelling, presence of a blister, redness of skin and/or skin rash. Skin wound at the site of injection. Painful glands near the elbows or under the arm. Joint swelling and pain. Burning sensation, partial loss of sensitivity, feeling of pins and needles or numbness. Dizziness, headache, nausea. Increased perspiration. SO THAT YOU ARE FULLY INFORMED, REMEMBER THAT THERE ARE ALTERNATIVES TO XIAPEX: Needle Aponeurotomy: less chance of pain, bruising, skin split, blister but less accurate and higher recurrence, Cheaper. Surgery: lower recurrence (especially if skin graft) but much longer recovery and higher chance of a significant complication (nerve damage, stiffness, wound problems). More expensive. Scarring.

6 CONFLICT OF INTEREST STATEMENT David Warwick s involvement has led to financial reimbursement from the company marketing the drug, This reward has included sponsorship to attend scientific meetings and professional fees for advisory work. This potential conflict of interest is declared. DAVID WARWICK S INVOLVEMENT IN XIAPEX AND DUPUYTREN S He was one of the first to use the drug in the UK, as Chief Investigator for a scientific study. He has continued to use the surgical drug in routine clinical practice, having performed over 360 injections by October He has also performed over 1000 operations for Dupuytren s.. Professor Warwick has led the training for use of this drug in the whole of Europe, as Chairman of the Xiapex Advisory Board. He is the lead author on several peer reviewed publications and book chapters. He is Editor in chief of the comprehensive European book on Dupuytren s Disease. His own results have been presented at national and international meetings. My recent Dupuytren s papers! 2015 Warwick D, Graham D, Worley P (2015) New insights into the immediate outcome of collagenase injections for Dupuytren s Contracture. J Hand Surg 2015 (on line DOI: / ) Warwick D, Arandes-Renu J, Pajardi G, Witthaut G, Hurst L Collagenase Clostridium histolyticum: emerging practice patterns and treatment advances. In press Journal of Plastic Surgery and Hand Surgery D. Warwick, M. Arner, G. Pajardi, B. Reichert, Z. Szabo, E. H. Masmejean, J. Fores, D. S. Chapman, R. A. Gerber, F. Huard, A. Seghouani1 and P. P. Szczypa Collagenase Clostridium histolyticum in patients with Dupuytren s contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes J Hand Surg 2015; ;40E: ! Arvind M, Vadher J, Ismail H, Warwick D (2014) The Southampton Dupuytren s Scoring Scheme Plast Surg Hand Surg Feb;48(1):28-33! Warwick D, Thomas A, Bayat A. (2012) Dupuytren s Disease: Overview of a common connective tissue disease with a focus on emerging treatment options International Journal of Rheumatology : ! Warwick D, Vadher J Belward P, Setty K. (2010)The Southampton Dupuytren s Clinic:, audit of an effective multidisciplinary model. Hand Therapy 2010;15: for free download of this Dupuytren s book: living-textbook-hand-surgery/ chapter/special-diseases-egdupuytrens-disease

7