Post-switch Effectiveness of Etanercept Biosimilar Versus Continued Etanercept in Rheumatoid Arthritis Patients with Stable Disease: A Prospective Multinational Observational Study.

INTRODUCTION: To better inform clinicians about the use of etanercept biosimilar (SB4) in patients with rheumatoid arthritis (RA), COMPANION-B, a prospective real-world observational study, evaluated the effectiveness of the voluntary switch from originator (etanercept, ETN) to SB4 in patients with stable RA (low-disease activity/remission). METHODS: The study recruited adult patients (18 years or older) with RA (2010 American College of Rheumatology criteria) prescribed ETN as their first or second biologic for at least 6 months across 14 sites in Canada and five in Australia. Patients had stable disease (Disease Activity Score-28 using erythrocyte sedimentation rate [DAS28-ESR] less than 3.2) at enrollment with no evidence of flare within the previous 3 months. Concomitant disease-modifying antirheumatic drugs (DMARDs) were permitted. Patients could elect to continue ETN or voluntarily switch to SB4 in consultation with their doctors. The primary effectiveness measure was the proportion of patients with disease worsening (defined as a DAS28-ESR increase of at least 1.2 from baseline and minimum score of at least 3.2 or a defined modification in RA treatment) during 12 months of follow-up. The secondary effectiveness measure was the proportion of patients with disease worsening at month 6. Serious adverse events (SAEs) and non-serious adverse reactions (NSARs) were recorded. RESULTS: Of 163 patients enrolled, 109 elected to continue on ETN and 54 switched to SB4; 65.8% of patients received non-biologic DMARD(s), 52.6% methotrexate, and 10.5% oral corticosteroid(s). At month 12, the proportion of patients with disease worsening was comparable in the ETN group (22.8% [95% CI 15.0-32.2]) and SB4 group (17.6% [95% CI 8.4-30.9]). Similarly, the proportions of patients with disease worsening were also comparable at month 6 (ETN: 7.9% [95% CI 3.5-15.0]; SB4: 7.8% [95% CI 2.2-18.9]). SAEs were low and similar across both groups (ETN: 8.7%; SB4: 5.7%). NSARs were slightly higher in the SB4 vs. ETN group (13.2% vs. 2.9%). CONCLUSIONS: SB4 demonstrated comparable effectiveness to ETN over 12 months in patients with stable RA who voluntarily switched to the biosimilar in a real-world setting.

Ultrasound Identification of Diaphragm by Novices Using ABCDE Technique.

BACKGROUND AND OBJECTIVES: In this study, we examined the consistency, rapidity, and reproducibility of the ABCDE technique for diaphragm identification. Operators using this method place the probe at the Anterior axillary line, watch for Breathing (lung sliding), and then move the probe Caudally to identify the Diaphragm for Examination. METHODS: A convenience sample of 100 patients was recruited from the preadmission clinic. Two novice operators each scanned the diaphragm using a linear ultrasound transducer in B-mode. Both operators completed the examination on all participants using the ABCDE technique, their times were averaged, and clinical success was defined as identification of the diaphragm in less than 2 minutes. RESULTS: An average of 33.7 seconds was taken to scan and identify the right hemidiaphragm (RD) (median, 25 seconds; 95% confidence interval, 28.8-38.5 seconds) with a 98% clinical success ratio, and an average of 46.9 seconds was taken to identify the left hemidiaphragm (LD) (median, 39.5 seconds; 95% confidence interval, 40.2-53.6 seconds) with a 97% clinical success ratio. In patients with a body mass index (BMI) of less than 30 kg/m, a 100% success ratio was seen when scanning the RD and 97% when scanning the LD. For those with a BMI of 30 kg/m or greater, a 94% success rate was seen when scanning the RD and 97% when scanning the LD. No clinically significant differences were found between the times required for scanning either side of the diaphragm, regardless of the BMI. CONCLUSIONS: The ABCDE technique demonstrates a fast, reliable, and simple method in which ultrasound can be used to visualize the diaphragm.

Intubation Success through I-Gel® and Intubating Laryngeal Mask Airway® Using Flexible Silicone Tubes: A Randomised Noninferiority Trial.

Introduction. The study aims to test whether flexible silicone tubes (FST) improve performance and provide similar intubation success through I-Gel as compared to ILMA. Our trial is registered in CTRI and the registration number is "CTRI/2016/06/006997." Methods. One hundred and twenty ASA status I-II patients scheduled for elective surgical procedures needing tracheal intubation were randomised to endotracheal intubation using FST through either I-Gel or ILMA. In the ILMA group (n = 60), intubation was attempted through ILMA using FST and, in the I-Gel group (n = 60), FST was inserted through I-Gel airway. Results. Successful intubation was achieved in 36.67% (95% CI 24.48%-48.86%) on first attempt through I-Gel (n = 22/60) compared to 68.33% (95% CI 56.56%-80.1%) in ILMA (n = 41/60) (p = 0.001). The overall intubation success rate was also lower with I-Gel group [58.3% (95% CI 45.82%-70.78%); n = 35] compared to ILMA [90% (95% CI 82.41%-97.59%); n = 54] (p < 0.001). The number of attempts, ease of intubation, and time to intubation were longer with I-Gel compared to ILMA. There were no differences in the other secondary outcomes. Conclusion. The first pass success rate and overall success of FST through an I-Gel airway were inferior to those of ILMA.