ObjectiveTo demonstrate clinical equivalence of adalimumab biosimilar candidate BI 695501 with Humira.MethodsPatients with active rheumatoid arthritis on stable methotrexate were randomised to BI 695501 or Humira in a double-blind, parallel-group, equivalence study. At week 24, patients were rerandomised to continue BI 695501 or Humira, or switch from Humira to BI 695501. The coprimary endpoints were the percentage of patients achieving the American College of Rheumatology 20% response criteria (ACR20) at weeks 12 and 24. Further efficacy and safety endpoints and immunogenicity were assessed up to week 58.Results645 patients were randomised. At week 12, 67.0% and 61.1% (90% CI –0.9 to 12.7) of patients receiving BI 695501 (n=324) and Humira (n=321), respectively, achieved ACR20; at week 24 the corresponding values were 69.0% and 64.5% (95% CI –3.4 to 12.5). These differences were within prespecified margins (week 12: 90% CI (–12% to 15%); week 24: 95% CI (−15% to 15%)), demonstrating therapeutic bioequivalence. 593 patients were rerandomised at week 24. Up to week 48, mean change from baseline in Disease Activity Score 28-erythrocyte sedimentation rate and ACR20/ACR50/ACR70 response rates were similar across the switched (n=147), continuous BI 695501 (n=298) and continuous Humira (n=148) groups. Similar immunogenicity (antidrug antibodies (ADAs), ADA titres and neutralising antibodies) was seen between BI 695501 and Humira (to week 24) and across rerandomised groups (to week 48). Safety and tolerability profiles were similar between groups.ConclusionsBI 695501 demonstrated similar efficacy, safety and immunogenicity to Humira; switch from Humira to BI 695501 had no impact on efficacy, safety and immunogenicity.Trial registration numberNCT02137226, Results.

Objective The optimal minimally invasive surgical management for patients with non-small-cell lung cancer (NSCLC) is unclear. For experienced video-assisted thoracoscopic surgery (VATS) surgeons, the increased costs and learning curve are strong barriers for adoption of robotics. We examined the learning curve and outcome of an experienced VATS lobectomy surgeon switching to a robotic platform. Methods We conducted a retrospective review to identify patients who underwent a robotic or VATS lobectomy for NSCLC from 2016 to 2018. Analysis of patient demographics, perioperative data, pathological upstaging rates, and robotic approach (RA) learning curve was performed. Results This study evaluated 167 lobectomies in total, 118 by RA and 49 by VATS. Patient and tumor characteristics were similar. RA had significantly more lymph node harvested (14 versus 10; P = 0.004), more nodal stations sampled (5 versus 4; P < 0.001), and more N1 nodes (8 versus 6; P = 0.010) and N2 nodes (6 versus 4; P = 0.017) resected. With RA, 22 patients were upstaged (18.6%) compared to 5 patients (10.2%) with VATS ( P = 0.26). No differences were found in perioperative outcome. Operative time decreased significantly with a learning curve of 20 cases, along with a steady increase in lymph node yield. Conclusions RA can be adopted safely by experienced VATS surgeons. Learning curve is 20 cases, with RA resulting in superior lymph node clearance compared to VATS. The potential improvement in upstaging and oncologic resection for NSCLC may justify the associated investments of robotics even for experienced VATS surgeons.

Summary What is this summary about? Here, we summarize the results from the VOLTAIRE-RA study, originally published in the journal Annals of the Rheumatic Diseases. The VOLTAIRE-RA study looked at how effective and safe BI 695501 is in treating people with rheumatoid arthritis (also known as RA). BI 695501 is a biosimilar whose reference product is adalimumab (known by the brand name Humira). A biosimilar is one that is made to be very similar to, and less expensive than the original biologic, also known as the reference product. The VOLTAIRE-RA study aimed to show that BI 695501 is as effective and safe as Humira in treating people with moderate-to-severe RA. What were the results? Participants of the VOLTAIRE-RA study took either Humira for 24 weeks and then switched to taking BI 695501 for a further 24 weeks, or BI 695501 for 48 weeks. The participants treated with BI 695501 and Humira had very similar outcomes in terms of reducing symptoms, as well as experiencing side effects. This was also seen for those participants who switched from taking Humira to BI 695501. What do the results mean? These results show that both Humira and BI 695501 could be used to treat people with RA as very similar treatment outcomes could be expected. Clinical Trial Registration: NCT02137226 ( ClinicalTrials.gov )