Efficacy and Drug Survival after Switching from Etanercept to the Biosimilar SB4: A Real-Life Long-Term Study

We evaluated the 3-year drug survival and efficacy of the biosimilar SB4/Benepali in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) patients, pre-viously treated with etanercept (ETA). Drug survival rate was calculated using the Kaplan\u2013Meier method and Cox proportional hazard models were developed to examine predictors of SB4 discontin-uation. 236 patients (120 RA, 80 PsA and 36 AS), aged 60.7 \ub1 13.8 years and with an ETA duration of 4.1 \ub1 3.4 years were included. The 3-year retention rate for SB4 was 94.4%, 88% and 86% in AS, RA and PsA patients, respectively, with no difference between groups. Patients without comorbid disease had higher retention rates vs. patients with comorbid disease (90% vs. 60%, p < 0.0001). Disease activity, as measured by DAS28, DAPSA and BASDAI remained stable over the 3 years. Comorbid disease (hazard ratio; HR: 4.06, p < 0.0001) and HAQ at baseline (HR: 2.42, p = 0.0024) significantly increased the risk of SB4 discontinuation, while previous ETA duration was negatively associated with SB4 discontinuation (HR: 0.97, p = 0.0064). Forty-one (17.4%) patients left the study due to the interruption of the SB4 treatment, 31 (75.6%) discontinued due to inefficacy and 10 (24.4%) due to adverse events. This real-life study confirms the similar efficacy profile of ETA with long-term retention and a good safety profile in inflammatory arthritis patients

Inexpensive homemade models for ultrasound-guided vein cannulation training.

STUDY OBJECTIVE: To test the hypothesis that low-cost homemade models may be used to acquire the basic skills for ultrasound-guided central vein puncture. DESIGN: Training study. SETTING: University transplantation department. MEASUREMENTS: Training was performed using three different homemade models (A, B, and C). Segments of a common rubber tourniquet (V1) and Silastic tube (V2) were used to simulate vessels within agar-based models. Overall cost for each model was less than 5 euro (US$7). For each test (test I, A-V1; II, A-V2; III, B-V1; IV, C-V2), the number of punctures and attempts needed to locate the needle inside the lumen were recorded. Each test was considered completed when participants punctured the vessels at the first attempt for three consecutive times. MAIN RESULTS: In test I, the mean number of punctures and attempts were 3.85 +/- 1.26 and 4.95 +/- 3.05; in test II, 4.60 +/- 1.14 and 6.30 +/- 2.51; in test III, 4.80 +/- 1.06 and 4.65 +/- 2.21; and in test IV, 4.45 +/- 1.23 and 6.05 +/- 2.92, respectively. For each test, no statistical difference was found by comparison of number of punctures and attempts for anesthesiologists versus nonanesthesiologists, men versus women, or previous experience versus no experience with central vein cannulation (CVC). Video game users obtained better results than did nonusers in test I (punctures, P = 0.033; attempts, P = 0.038), test II (punctures, P = 0.052; attempts, P = 0.011), and test IV (punctures, P = 0.001; attempts, P = 0.003). A posttraining questionnaire showed favorable opinions about the clarity of the instructions, aptness of the models, and adequacy of the training. In our operative unit, the use of ultrasound guidance for CVC increased from 2% to 23% in the first month after training. CONCLUSION: Low-cost homemade models are useful in acquiring basic coordination skills for ultrasound-guided CVC

Abdominal compartment syndrome in pediatric kidney transplantation.

none8noBackground: Transplantation of large kidney in small children can lead to many complications. One of these, often underrated, is abdominal compartment syndrome (ACS). An early diagnosis of ACS is recommended to prevent multi-organ failure. Patient and Methods: From June 1985 to June 2007 we have performed 314 kidney transplants (KT) in pediatric patients (male/female: 167/147). Deceased donors were used in 289 procedures, while 25 KT were carried out from living related donors. In this cohort, the weight of 83 kidney recipients was less than 20 Kg. Of these patients, 16 received a large kidney. Results: ACS occurred in 7 kidney recipients (hemodialysis/peritoneal dialysis: 5/2). All patients weighted less than 15 Kg. The kidney was procured from adult donors. The ACS signs included firm tense abdomen, hypotension, reduction in ventilation, decrease in lung compliance, increase in airways pressure (increase peak inspiratory pressure), impaired gas exchange with possible hypercarbia and acidosis. In one case a patient underwent abdominal decompression by re-exploration and closure with a PTFE mesh in the immediate post-operative period. From 2005 we measured during transplantation the possible intra-abdominal hypertension via urinary bladder pressure. Conclusions: In pediatric kidney recipients, especially for the condition “large kidney in small children”, the continuous measurement of urinary bladder pressure may be a simple, non invasive and inexpensive approach to provide an early detection of ACS.noneFONTANA I; BERTOCCHI M; CENTANARO M; SANTORI G; RÈ F; CAVALLERO T; GINEVRI F; VALENTE U.Fontana, I; Bertocchi, M; Centanaro, M; Santori, Gregorio; Rè, F; Cavallero, T; Ginevri, F; Valente, Umbert

Efficacy of bosentan in the treatment of Raynaud’s phenomenon in patients with systemic sclerosis never treated with prostanoids

The objective of this study was to evaluate the efficacy of the endothelin receptor antagonist, bosentan, in patients with Raynaud’s phenomenon secondary to systemic sclerosis never treated with prostanoids and without digital ulcers. The study design is a preliminary, prospective open label trial. The patients recruited took one 62.5 mg dose of bosentan twice daily for 4 weeks, followed by 125 mg twice daily for 24 weeks. Of the 10 patients recruited, all completed the study. The reduction in Raynaud’s phenomenon attacks at week 24 from the baseline was statistically significant (Δ-1.3, P=0.0126). The Raynaud’s condition score showed a statistically significant improvement (Δ-1.4, P=0.0279), as did the visual analog pain scale (Δ-1.5, P=0.0016) at the 24^th week. Bosentan appears to be effective and may be a valid alternative for the treatment of severe secondary Raynaud’s phenomenon for patients where prostanoids therapy is contraindicated or refused