Time, Psoriasis Area and Severity Index and Dermatology Life Quality Index of patients with psoriasis who drop out of clinical trials on etanercept because of lack of efficacy: a pooled analysis from 10 clinical trials.

BACKGROUND: Patient-reported outcomes in psoriasis studies are assessed at specific study time points. If a treatment has not become effective by a certain time point, it may increase the likelihood of patients being dissatisfied and leaving a clinical study. OBJECTIVES: To generate evidence concerning the number of patients dropping out of etanercept trials over time including Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) data. METHODS: Data from patients with psoriasis in 10 trials with etanercept were pooled. Analyses were performed for (i) patients who dropped out because of 'lack of efficacy' and (ii) patients who continued the trial. The PASI and DLQI data were summarized for different time points. The distribution of dropout over time, PASI, DLQI and the proportion of patients dropping out with given treatment responses were calculated. RESULTS: Of 6119 patients, 128 dropped out because of lack of efficacy (or synonym). The highest increase of patients dropping out happened between day 75 and 85 (cumulative percentage rise from 46% to 73%). The lowest PASI of patients dropping out was 6·3 within 120 days. Individuals who dropped out who achieved ≥ PASI 75 (at least a 75% improvement from baseline PASI) were rare. CONCLUSIONS: A critical time when many patients might have lost their willingness to wait for their treatment with etanercept to show a better effect appeared to be at around day 80. Most of the patients dropping out showed little improvement, stable disease or worsening of their psoriasis.

Safety and tolerability of collagenase Clostridium histolyticum and fasciectomy for Dupuytren's contracture.

Safety was evaluated for collagenase Clostridium histolyticum (CCH) based on 11 clinical trials (N = 1082) and compared with fasciectomy data in a structured literature review of 48 European studies (N = 7727) for treatment of Dupuytren's contracture. Incidence of adverse events was numerically lower with CCH vs. equivalent complications from fasciectomy (median [range] incidence), including nerve injury (0% vs. 3.8% [0%-50+%]), neurapraxia (4.4% vs. 9.4% [0%-51.3%]), complex regional pain syndrome (0.1% vs. 4.5% [1.3%-18.5%]) and arterial injury (0% vs. 5.5% [0.8%-16.5%]). Tendon injury (0.3% vs. 0.1% [0%-0.2%]), skin injury (16.2% vs. 2.8% [0%-25.9%]) and haematoma (77.7% vs. 2.0% [0%-25%]) occurred at a numerically higher incidence with CCH than surgery. Adverse events in CCH trials not reported after fasciectomy included peripheral oedema; extremity pain; injection site pain, haemorrhage and swelling; tenderness; pruritus and lymphadenopathy. CCH-related adverse events were reported as predominantly injection-related and transient. These results may support clinical decision-making for treatment of Dupuytren's contracture.

Collagenase clostridium histolyticum in patients with Dupuytren's contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes.

In POINT X, a study designed to reflect clinical practice and patient treatment choices, 254 European patients received open-label collagenase for Dupuytren's contracture. The most severely affected joint was treated first in 74% of patients. In total, 52%, 41%, 7%, and 1% of patients selected the little, ring, middle, and index finger, respectively; 79% had one or two joints treated. Only 9% of patients (n = 24) received 4 or 5 injections. The mean improvement in total passive extension deficit (TPED) was 34° on day 1, improving further by day 7 to 42°. This secondary improvement was maintained by day 90 and month 6. The mean number of injections/joint was 1.2 for the metacarpophalangeal joint and 1.25 for the proximal interphalangeal joint. Median time to recovery was 4 days; the mean improvement in hand function was clinically relevant as measured by the Unité Rhumatologique des Affections de la Main (URAM) score. In total, 87% and 86% of patients and physicians, respectively, were very satisfied or satisfied with treatment at month 6, although correlation between TPED and patient satisfaction was weak (Spearman -0.18, 95% CI -0.32 to -0.06). Collagenase was well tolerated, with 10 (3.9%) patients experiencing severe adverse events. As a real-world study, the POINT X findings can be generalized to the at-large population.

Dupuytren's disease presentation, referral pathways and resource utilisation in Europe: regional analysis of a surgeon survey and patient chart review.

AIM: We explored the management of Dupuytren's disease (DD) using a surgeon survey and patient chart review. METHODS: Twelve countries participated: Denmark, Finland, Sweden (Nordic region); Czech Republic, Hungary, Poland (East); France, Germany, the Netherlands, United Kingdom (West); Italy, Spain (Mediterranean). A random sample of orthopaedic/plastic surgeons (N = 687) with 3-30 years' experience was asked about Dupuytren's contracture procedures performed during the previous 12 months. Information ≤ 5 consecutive patients per surgeon was extracted from patient charts (N = 3357). RESULTS: Overall, 84% of participants were orthopaedic surgeons; 56% of surgeons were hand specialists. Deciding factors for fasciectomy and dermofasciectomy were consistent across regions: metacarpophalangeal (MP) or proximal interphalangeal contracture > 45°, recurrent contracture, and high expectations for success. Deciding factors for percutaneous needle fasciotomy were less consistent across regions, but the leading factor was MP flexion < 20°. Overall, 49% of diagnoses and 55% of referrals were made by a general practitioner (GP), with regional variation: 31-77% for GP diagnoses and 36-81% for GP referrals. There were also differences in admission status (e.g. 9% of Nordic patients and 80% of Eastern patients were treated as inpatients). Most patients were treated in public hospitals and most procedures were covered by public health insurance. CONCLUSIONS: We found regional variations in surgical practice, patient characteristics and referral patterns. Understanding current diagnosis and treatment patterns, in relation to regional differences in health economics, may improve physicians' diagnosis of DD and guide patients towards appropriate, customised management plans.

Surgical management of Dupuytren's contracture in Europe: regional analysis of a surgeon survey and patient chart review.

AIM: We explored regional variations in the surgical management of patients with Dupuytren's contracture (DC) in 12 European countries using a surgeon survey and patient chart review. METHODS: Twelve countries participated: Denmark, Finland, Sweden (Nordic region); Czech Republic, Hungary, Poland (East); France, Germany, the Netherlands, UK (West); Italy, Spain (Mediterranean). For the survey, a random sample of orthopaedic/plastic surgeons (n = 687) with 3-30 years' experience was asked about DC procedures performed during the previous 12 months. For the chart review (n = 3357), information from up to five consecutive patients was extracted. Descriptive statistics are reported. RESULTS: Ninety-five per cent of all surgeons used fasciectomy for DC, followed by fasciotomy (70%), dermofasciectomy (38%) and percutaneous needle fasciotomy (35%). Most surgeons were satisfied with fasciectomy over other procedures. Recommended time away from work and duration of physical therapy increased with the invasiveness of the procedure. The intra-operative complication rate was 4.0%; the postoperative complication rate was 34%. Overall, ≥ 97% of the procedures were rated by surgeons as having a positive outcome. Across all regions, 54% of patients had no nodules or contracture after the procedures. Only 2% of patients required retreatment within the first year of surgery. Important inter- and intraregional differences in these aspects of patient management are described. CONCLUSIONS: Understanding current regional treatment patterns and their relationships to country-specific health systems may facilitate earlier identification of, and intervention for, DD and help to optimise the overall treatment for patients with this chronic condition.