Abstract
IntroductionSince March 2011, the microbial collagenase of Clostridium histolyticum (Xiapex®, Swedish Orphan Biovitrum AB, Stockholm, Sweden) has become available in the European Union for treatment of Dupuytren’s disease. The purpose of this study was to evaluate potential safety risks of Xiapex® and to contribute to a better understanding for its use.MethodsA prospective, non-interventional, observational study using Xiapex® for Dupuytren’s disease named XIANIS was conducted between 1.10.2011 and 01.10.2017. Treatment was conducted in accordance to the manufacturer information. Patients were invited for follow-up after 1 week, 1 month, 3 months and 1 year. Demographic data, treatment data, pain levels, anaesthetic application during passive manipulation, subjective function improvement, subjective satisfaction and adverse events were recorded.Results788 patients with 814 treatments were included who suffered from Dupuytren’s contracture for a mean of 64 months. The metacarpophalangeal joint was affected in 57% of cases and the PIP joint in 40.8% with a mean contracture of 39° and 56°, respectively. A change in the contracture down to 0°–5° was reported in 66.5% of cases, while 25.5% achieved a partial improvement. The pain during the injection was rated 4.5 and 3.3 during passive manipulation. Adverse events were reported in the majority of treated patients with skin tears being one main common event (26%). Further adverse outcomes were bleeding/hematoma, joint swelling, injection-site swelling, pressure sensitivity, erythema, injection-site pain, peripheral edema, blood blisters, blisters, painless lymphadenopathy, painful lymphadenopathy, axillary pain, arthralgia and sensory abnormality. There were no reported tendon ruptures, anaphylactic reactions or ligament injuries. On 1-year follow-up, 29% showed an increased contracture of a mean of 24° with the need for surgical treatment in 2% of patients. 74% of patients were very satisfied and 72% showed a high functional improvement.ConclusionThe injectable collagenase Clostridium histolyticum (Xiapex®) proved to be effective and safe in patients with Dupuytren’s disease. Minor adverse events disappeared within 30 days and the need for surgical treatment within 1 year was very low (2%). No major complications or rare side effects were seen in this prospective observational study.
Highlights
Since March 2011, the microbial collagenase of Clostridium histolyticum (Xiapex®, Swedish Orphan Biovitrum AB, Stockholm, Sweden) has become available in the European Union for treatment of Dupuytren’s disease
The subjective patient satisfaction was mostly very high (Table 2). This prospective observational study in a large cohort showed that the application of Xiapex® for Dupuytren’s disease is effective and safe as adverse events were of mainly minor genesis, resolved within a short time period and
The effectiveness of Xiapex® has been shown in multiple previous studies [23, 18, 17, 24, 14, 25, 13] with 51–92% of patients achieving a postinterventional contracture of 0°–5° directly after manipulation [13, 25, 17, 26] similar to our observational report with 66.5%
Summary
Since March 2011, the microbial collagenase of Clostridium histolyticum (Xiapex®, Swedish Orphan Biovitrum AB, Stockholm, Sweden) has become available in the European Union for treatment of Dupuytren’s disease. Methods A prospective, non-interventional, observational study using Xiapex® for Dupuytren’s disease named XIANIS was conducted between 1.10.2011 and 01.10.2017. Results 788 patients with 814 treatments were included who suffered from Dupuytren’s contracture for a mean of 64 months. On 1-year follow-up, 29% showed an increased contracture of a mean of 24° with the need for surgical treatment in 2% of patients. Conclusion The injectable collagenase Clostridium histolyticum (Xiapex®) proved to be effective and safe in patients with Dupuytren’s disease. Dupuytren’s disease is a common benign fibromatosis of the fibrous skeleton of the hand manifesting in a progressive flexion contracture of the hand [1]. The complication rate for surgical treatment ranges between 4 and 39% including poor wound healing, scar pain, paraesthesia, hypoesthesia, flare reaction, complex regional pain syndrome, infections, hematoma and nerve or vessel injuries [7,8,9,10]. Nonsurgical interventions have proved to be largely ineffective and rejected clinically [11]
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