The ORAL Surveillance study is a phase 4, open-label, safety trial designed to assess whether adverse effects of the Janus kinase (JAK) inhibitor tofacitinib were comparable (ie, non-inferior) to TNF inhibitors with regard to major adverse cardiovascular events (MACE) and malignancies in high-risk patients with rheumatoid arthritis. Patients with moderate-to-severe rheumatoid arthritis unresponsive to methotrexate, aged 50 years or older, with one or more additional cardiovascular risk factors were randomly assigned (1:1:1) to receive tofacitinib 5 mg (n=1455) or 10 mg (n=1456) twice daily, or a TNF inhibitor (n=1451; adalimumab 40 mg every other week in North America or etanercept 50 mg every week elsewhere); all patients continued taking methotrexate. The primary results of ORAL Surveillance were presented by Roy Fleischmann (University of Texas Southwestern Medical Center, Dallas, TX, USA). Tofacitinib failed to show non-inferiority compared to TNF inhibitors for both MACE and malignancies (excluding non-melanoma skin cancer), with the upper limit of the 95% CI exceeding the non-inferiority margin of 1·8 for both outcomes (hazard ratio [HR] 1·33 [95% CI 0·91–1·94] for MACE and 1·48 [1·04–2·09] for malignancies). A post-hoc analysis of the risk factors for MACE in ORAL Surveillance was presented by Christina Charles-Schoeman (University of California Los Angeles, Los Angeles, CA, USA). Baseline factors including current smoking (HR 2·18 [95% CI 1·50–3·16]), aspirin use (2·11 [1·40–3·19]), age 65 years or older (1·81 [1·27–2·59]), and male sex (1·81 [1·25–2·61]) were identified as independent risk factors for MACE, irrespective of treatment assignment. In a post-hoc analysis presented by Jeffrey Curtis (University of Alabama at Birmingham, Birmingham, AL, USA), age 65 years or older (HR 2·04 [1·49–2·78]), current smoking (2·61 [1·79–3·81]), and past smoking (2·58 [1·72–3·73]) were identified as independent risk factors for malignancies.

We are pleased to invite submission of abstracts for oral and poster presentation at The Lancet Summit: Sex and gender in rheumatology, a virtual meeting to be held on Sept 22-23, 2022. In conjunction with the Summit, we will publish a special issue of The Lancet Rheumatology dedicated to the meeting theme, and we welcome submissions of original research on any topic related to sex and gender in rheumatology via our online submission system.

Enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) are types of juvenile idiopathic arthritis (JIA) that represent the paediatric correlates of axial spondyloarthritis and psoriatic arthritis. In the phase 3 JUNIPERA trial, presented by Nicolino Ruperto (Università di Genova Pediatria, Italy), the interleukin (IL)-17A inhibitor secukinumab significantly reduced the risk of disease flares in children and adolescents (aged 2–18 years) with ERA and JPsA. In the initial open-label phase of the trial, all patients received subcutaneous secukinumab (75 mg in patients <50 kg and 150 mg in patients ≥50 kg) for 12 weeks. 75 (90·4%) of 83 patients had a 30% improvement in JIA American College of Rheumatology (JIA ACR 30) response at week 12 and were randomly assigned (1:1) to blinded secukinumab or placebo once every 4 weeks until a disease flare, or until week 100. In the double-blind phase, there were 21 flares in the placebo group (n=38) and ten flares in the secukinumab group (n=37). Time to flare (the primary outcome) was significantly longer on secukinumab than on placebo, and risk of flare was reduced on secukinumab (hazard ratio 0·28; 95% CI 0·13–0·63; p<0·001). At week 104, 89·2% of patients on secukinumab had a JIA ACR 30 response compared with 64·9% of patients on placebo (p=0·014). Adverse events were similar between groups and no new safety signals were observed.

When we launched The Lancet Rheumatology in 2019, a fundamental part of our mission was to use our pages to advocate for the improved lives of patients with rheumatic diseases around the globe. Helping to improve patients' lives requires an understanding of their needs and the ways in which science and medicine might be struggling to meet those needs. But ‘unmet need’ means different things to different people and different patient populations, driven by myriad factors including geographical location, socioeconomic factors, health literacy, and availability of and access to care (to name just a few). The reality of clinical research is that most studies and clinical trials are done in well-funded research institutes in high-income countries. Reflecting this, a majority of research Articles submitted to The Lancet Rheumatology are from authors in the UK, USA, and Europe; countries in South America and Africa are particularly underrepresented. Indeed, these trends are similar across many (if not most) research journals. A related problem is that patient populations included in clinical trials are highly selected and not always representative of all patients—issues that can adversely affect health equity. In an effort to gain insight into the many dimensions of unmet need across the globe, The Lancet Rheumatology is launching a Podcast Series featuring interviews with rheumatology specialists and clinical researchers working in a variety of settings and geographical regions worldwide, to get a first-hand view of the challenges they face and what unmet need means to them and their patients. As part of this project, we are seeking three guest editors—ideally early-career rheumatologists and researchers—to join The Lancet Rheumatology editorial team in conducting these interviews and also to lend their insights as clinicians and researchers. As with our interviewees, we are looking for guest editors working in a variety of clinical settings and from distinct geographical regions. If you are interested in collaborating with us on this exciting project and joining these illuminating conversations, please send your CV and a brief statement of interest to The Lancet Rheumatology at [email protected] The deadline for applications is July 15, 2021. We look forward to adding your voices to our own as we explore the challenges facing clinicians and patients across the globe. I declare no competing interests.