Use of Auto-Injector for Methotrexate Subcutaneous Self-Injections: High Satisfaction Level and Good Compliance in SELF-I Study, a Randomized, Open-Label, Parallel Group Study

International audienceINTRODUCTION:The objective of the study was to compare compliance and acceptability of a new auto-injector (AI) versus syringe for administration of methotrexate (MTX) in patients with rheumatoid arthritis (RA).METHODS:We conducted a randomized, open-label, parallel group study comparing AI to pre-filled syringe (PFS). Adult patients with RA (ACR/EULAR 2010) receiving MTX (orally or by injection) for at least 3 months were allocated to AI or PFS for 6 months and then were allocated to AI for 6 further months. Two co-primary endpoints were defined at M6: percentage of patients with compliance at least 80%; change in functional capacity assessed by Health Assessment Questionnaire (HAQ). Secondary endpoints included quality of life (RaQoL), RA activity (DAS28), and acceptability. Local safety at injection site was assessed at each visit.RESULTS:Two-hundred and sixty-five patients were randomized. The main analysis was conducted on per protocol set (99 AI and 98 PFS). Compliance was 96.2% in AI and 98.9% in PFS. Good complier rates were 89.9% and 94.9%, thus a difference of - 5.0% (- 18.9%; 8.9%). HAQ remained stable in both groups. No difference was found on RaQoL, change in RA activity, and safety profile. Autonomy, acceptability, and patient satisfaction were better with AI, and patients having had the experience of both AI and PFS preferred AI (p < 0.001).CONCLUSIONS:Although this study did not demonstrate non-inferiority of AI versus PFS, compliance was excellent in the two groups, and AI, which was preferred by patients, is a valuable alternative to PFS for administration of MTX.ClinicalTrials.gov identifier, NCT02553018

Is it necessary to weight by weight the dosage of MTX in RA patients? Results from observational analysis of baseline data of a phase III trial.

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Patients preference goes to methotrexate autoinjectors over prefilled syringes: results from a phase III trial, SELFI

International audienc

Patients preference goes to methotrexate autoinjectors over prefilled syringes: results from a phase III trial, SELFI

International audienc

Is it necessary to weight by weight the dosage of MTX in RA patients? Results from observational analysis of baseline data of a phase III trial.

International audienc

MTX optimization or adding bDMARD equally improve disease activity in rheumatoid arthritis: results from the prospective study STRATEGE

International audienceObjectives. The STRATEGE (Therapeutic Strategy in Patients Treated With Methotrexate for Rheumatoid Arthritis) study aimed to describe treatment strategies in current practice in RA biologic DMARD (bDMARD)-naïve patients with an inadequate response to MTX therapy, and to compare clinical efficacy of the different therapeutic strategies on disease activity after 6 months. Methods. The main inclusion criteria of this prospective, observational, multicentre study were confirmed RA diagnosis, treatment by MTX monotherapy and need for therapeutic management modification.Results. The 722 patients included had a mean (s.d.) RA duration of 5.3 (6.7) years, a mean DAS28 of 4.0 (1.1); they were all receiving MTX monotherapy, 68% oral, at a mean dose of 15.0 (4.1) mg/week. Two major strategies were identified: (i) MTX monotherapy dose and/or route optimization (72%) and (ii) bDMARD initiation ± MTX (16%). MTX dosing was modified for 70% of patients, maintained (dose and route) for 28% of patients and interrupted for 2%. bDMARDs were started when the MTX mean dose was 17.4 mg/week, 56% parenterally; MTX was maintained concomitantly for 96% of patients. Six-month follow-up results adjusted by propensity score showed that both options were equally successful in improving disease activity and physical function, with 63 and 68% of good-to-moderate EULAR responses, respectively.Conclusion. The STRATEGE study shows the importance of initial MTX treatment optimization before initiation of a biological treatment and emphasizes the importance of treat-to-target strategy

At which point and for which reasons are oral MTX formulations switched to injectable ones in RA patients? combined results from 3 independent observational and clinical trials

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Impact of Chloroprocaine on the Eligibility for Hospital Discharge in Patients Requiring Ambulatory Surgery Under Spinal Anesthesia: An Observational Multicenter Prospective Study

International audienceIntroduction: This observational study was designed to assess the use of spinal anesthesia with chloroprocaine in the context of ambulatory surgery. Methods: A prospective, multicenter, observational study was carried out among 33 private or public centers between May 2014 and January 2015 and adult patients, scheduled for a short ambulatory surgery under spinal anesthesia with chloroprocaine. The primary outcomes were anesthetic effectiveness, defined as performance of the whole surgical procedure without any additional anesthetic agent, and the time to achieve eligibility for hospital discharge. Secondary outcomes were the effect of chloroprocaine on motor and sensory blocks, patients' satisfaction, and the use of analgesics in the first 24 h after surgery.Results: Among the 615 enrolled patients, 56% were male, the mean age was 47.2 ± 15.2 years, and most patients had an ASA (American Society of Anesthesiologists) status of 1 (63.7%). Main surgical procedures performed were orthopedic (62.6%) and gynecologic (16.1%), and the mean duration of surgery was 26.7 ± 16.7 min. The overall anesthetic success rate was 93.8% (95% CI [91.5%; 95.6%]) for the 580 patients with available data for primary criteria. The failure rate was lower than 7% for all surgical procedures, except for gynecologic surgery (14.8%; 95% CI [8.1%; 23.9%]). The average times of eligibility for hospital discharge and effective discharge were 252.7 ± 82.7 min and 313.8 ± 109.9 min, respectively. The time of eligibility for hospital discharge is defined as the recovery of the patient's normal clinical parameters and the time of effective discharge is defined as the time for the patient to leave the hospital after surgery. Eligibility for patient's discharge was achieved more rapidly in private than public hospitals (236.3 ± 77.2 min vs. 280.9 ± 80.7 min, respectively, p < 0.001).Conclusions: This study showed positive results on the effectiveness of chloroprocaine as a short-duration anesthetic and could be used to reduce the time to achieve eligibility for hospital discharge

Factors Determining the Choice of Spinal Versus General Anesthesia in Patients Undergoing Ambulatory Surgery: Results of a Multicenter Observational Study

International audienceAvailable short-acting intrathecal anesthetic agents (chloroprocaine and prilocaine) offer an alternative to general anesthesia for short-duration surgical procedures, especially ambulatory surgeries. Factors determining the choice of anesthesia for short-duration procedures have not been previously identified.Methods: This observational, prospective, multicenter, cohort study was conducted between July 2015 and July 2016, in 33 private or public hospitals performing ambulatory surgery. The primary objective was to determine the factors influencing the choice of anesthetic technique (spinal or general anesthesia). Secondary outcomes included efficacy of the anesthesia, time to hospital discharge, and patient satisfaction.Results: Among 592 patients enrolled, 309 received spinal anesthesia and 283 underwent general anesthesia. In both study arms, the most frequently performed surgical procedures were orthopedic and urologic (43.3% and 30.7%, respectively); 66.1% of patients were free to choose their type of anesthesia, 21.8% chose one of the techniques because they were afraid of the other, 16.8% based their choice on the expected ease of recovery, 19.2% considered their degree of anxiety/stress, and 16.9% chose the technique on the basis of its efficacy. The median times to micturition and to unassisted ambulation were significantly shorter in the general anesthesia arm compared with the spinal anesthesia arm (225.5 [98; 560] min vs. 259.0 [109; 789] min; p = 0.0011 and 215.0 [30; 545] min vs. 240.0 [40; 1420]; p = 0.0115, respectively). The median time to hospital discharge was equivalent in both study arms. In the spinal anesthesia arm, patients who received chloroprocaine and prilocaine recovered faster than patients who received bupivacaine. The time to ambulation and the time to hospital discharge were shorter (p < 0.001). The overall success rate of spinal anesthesia was 91.6%, and no significant difference was observed between chloroprocaine, prilocaine, and bupivacaine. The patients' global satisfaction with anesthesia and surgery was over 90% in both study arms.Conclusions: Patient's choice, patient fear of the alternative technique, patient stress/anxiety, the expected ease of recovery, and the efficacy of the technique were identified as the main factors influencing patient choice of short-acting local anesthesia or general anesthesia. Spinal anesthesia with short-acting local anesthetics was preferred to general anesthesia in ambulatory surgeries and was associated with a high degree of patient satisfaction