Rocatinlimab atopic dermatitis in two global phase 3 clinical trials.

# Rocatinlimab atopic dermatitis in two global phase 3 clinical trials *The Lancet 2026* Correspondence MTM represents an important advance Jeevarathinam Thirumalai, aphthous ulcers (4–5% vs 1% placebo), in reducing access barriers, particularly Indra Sivakumar, *Saravanan Sekaran leading to four discontinuations. for individuals with low mobility or saravanans.sdc@saveetha.com This pattern is unlike other atopic socioeconomic constraints. However, Saveetha Institute of Basic Medical Sciences dermatitis biologics (eg, dupilumab MTM also raises a broader systems (SIBMS), Saveetha Institute of Medical and Technical or tralokinumab).2 Given that question: whether access-focused Sciences (SIMATS), Saveetha University, OX40/OX40L signalling regulates Chennai 602105, India (JT, IS, SS) delivery innovations can improve T-cell activation and cytokine 1 Sharma DC. Bringing home NCD care in Tamil chronic disease outcomes without production in gastric tissue, these Nadu. Lancet 2026; 407: 323–24. parallel investments in continuity of 2 Subramaniam S, Somasundaram A, Cowshik E, events might reflect mechanism- care. et al. Makkalai Thedi Maruthuvam: evaluating based toxicity from disrupting equity in non-communicable disease care MTM operates within a wider through a doorstep primary health program in mucosal immune homeostasis primary care ecosystem that includes Tamil Nadu, India. BMC Prim Care 2026; 27: 17. rather than non-specific toxicity.3 3 Geldsetzer P, Manne-Goehler J, Marcus ME, decentralised services, health and These infrequent but distinct events et al. The state of hypertension care in 44 low- wellness centres, and population- income and middle-income countries: a cross- warrant discussion. based NCD screening programmes. sectional study of nationally representative Reliance on categorical endpoints individual-level data from 1·1 million adults. Since these components have largely Lancet 2019; 394: 652–62. such as EASI-75 and vIGA-AD scores, evolved as parallel programmes, gaps 4 WHO. WHO package of essential which often dichotomise clinical noncommunicable (PEN) disease interventions persist in integration across various outcomes, and predominantly binary for primary health care. Sept 7, 2020. https:// stages of care, particularly in referral iris.who.int/server/api/core/bitstreams/ secondary endpoints limits the clarity tracking, shared clinical records, b9f09202-a320-4c07-ba2c-afe0d1186339/ of effect size and direct comparison content (accessed Jan 25, 2026). and longitudinal follow-up. Similar with existing therapies. Percentage- 5 Gimigliano F, Negrini S. The World Health challenges reported within health and Organization “Rehabilitation 2030: a call for based comparisons across trials should action”. Eur J Phys Rehabil Med 2017; 53: 155–68. wellness centres and NCD screening therefore be cautiously interpreted. programmes suggest a systems- The authors describe potential level coordination gap, rather than a disease-modifying effects through Rocatinlimab atopic programme-specific limitation.2,3 selective targeting of OX40R-positive The consequences of this dermatitis in two global memory T cells, based on analyses to fragmentation are evident in patient date. Durability and long-term effects, phase 3 clinical trials outcomes. Despite expanded however, require future, longer-term screening and treatment initiation, data, which the authors plan to report, care cascade evaluations report The study1 by Emma Guttman- given the current 24-week report and glycaemic control in only 9·8% of Yassky and colleagues represents an reliance on peripheral blood findings. individuals with diabetes, and blood important and innovative contribution JJW declares grants from AbbVie, Galderma, pressure control in 35·4% of those to the evolving treatment landscape of Immunovant, and Novartis; consulting fees from with hypertension in Tamil Nadu, moderate-to-severe atopic dermatitis, Apogee Therapeutics, Veradermics, Botanix Pharmaceuticals, Takeda, Sun Pharma, and Meiji India.2 These findings suggest that particularly by targeting OX40. Use Seika Pharma; and honoraria from Galderma. All outreach-intensive models, such as of a placebo and allowance of rescue other authors declare no competing interests. MTM, are unlikely to deliver durable therapy, even for patients who did Khushi Gupta, Michael Ghebrial, gains without mechanisms that not respond to systemic treatments, Chiara Tognaccini, Dina Ghanim, support continuity of care and routine is clinically relevant. However, *Jashin J Wu monitoring.4 classifying all patients needing rescue jashinwu@gmail.com The inclusion of physiotherapy therapy as permanent non-responders and palliative care within MTM is a complicates efficacy interpretation. Emory School of Medicine, Atlanta, GA, USA (KG); University of California, Riverside School of notable strength. However, the scarce The sensitivity analysis, which included Medicine, Riverside, CA, USA (MG); California reporting of outcomes related to patients with less than 2 weeks of University of Science and Medicine, Colton, CA, USA functioning, disability, and quality of consecutive rescue therapy, attempted (CT); Kaiser Permanente Bernard J Tyson School of Medicine, Pasadena, CA, USA (DG); Department of life highlights an important evaluative to address this issue, but confounding Dermatology, University of Miami Miller School of gap. Incorporating functional and from the type, start date, and total Medicine, Miami, FL 33136, USA (JJW) patient-centred outcomes might help exposure of rescue therapy remains 1 Guttman-Yassky E, Kabashima K, Worm M, ensure that expanded reach translates likely. et al. Efficacy and safety of rocatinlimab for the treatment of moderate-to-severe atopic into meaningful improvements in Rocatinlimab was associated with dermatitis in ROCKET-IGNITE and ROCKET- chronic disease care.5 distinct mucosal adverse events, HORIZON: two global, double-blind, placebo- controlled, randomised phase 3 clinical trials. including serious gastrointestinal We declare no competing interests. Lancet 2026; 407: 53–66. ulceration (three patients) and 2 Kim YS. Comparative efficacy and safety of Correspondence tralokinumab and dupilumab in moderate-to- the criteria for identifying those who induction or elective caesarean. The severe atopic dermatitis: a narrative review. truly benefit remain unclear. The UK has a policy of caesarean by choice J Clin Med, 2025; 14: 4960. possibility that scheduled birth policies after appropriate counselling. 3 Ming S, Zhang M, Liang Z, et al. OX40L/OX40 signal promotes IL-9 production by mucosal could increase caesarean section rates The 30% reduction in pre-eclampsia MAIT cells during helicobacter pylori infection. warrants careful consideration. in the intervention (vs usual care) Front Immunol 2021; 12: 626017. group was not associated with a We declare no competing interests. significant reduction in pre-eclampsia *David Baud, Joanna Sichitiu, with severe features, however there Scheduled birth at term: Hélène Legardeur, Pauline de Vries, were numerically fewer women with benefit or trade-off? Manon Vouga severe features in the intervention david.baud@chuv.ch group (76 pregnancies, 1·9%) versus James Goadsby and colleagues report Lausanne University Hospital (CHUV) and University the usual care group (99, 2·4%), for that risk-stratified scheduled birth of Lausanne (UNIL), Lausanne 1011, Switzerland an adjusted relative risk (RR) of 0·77 (DB, JS, HL, PdV, MV) at term reduces the incidence of (95% CI 0·57–1·04). It is possible that 1 Goadsby J, Syngelaki A, Magee LA, et al. pre-eclampsia without increasing we lacked statistical power to establish Scheduled birth at term for the prevention of emergency caesarean section or pre-eclampsia (PREVENT-PE): an open-label whether the small absolute between- neonatal morbidity.1 Although the randomised controlled trial. Lancet 2026; group difference was significant. 407: 67–77. trial is carefully conducted, several Finally, although the prevalence contextual aspects limit its applicability of aspirin therapy in pregnancy was and weaken conclusions as to whether Authors’ reply 2·0% higher in the intervention (vs routine management, including post- David Baud and colleagues are right usual care) groups, aspirin had been dates delivery, remains a safe option. to consider context and how their stopped at 36 weeks’ gestation (as The caesarean section rate in this clinical setting compares with that in the ASPRE trial),4 and in subgroup cohort was unexpectedly high, with where the trial was done. However, analyses there was no interaction nearly one in two women (45%) we maintain that personalised timing between previous aspirin therapy and delivered by caesarean at a median of birth for women at increased risk of the intervention (p=0·39), which was gestational age of 39 weeks in pre-eclampsia is an intervention that effective in those who had taken aspirin both groups, suggesting that many identifies those who might benefit (RR 0·74, 95% CI 0·56–0·98) and those procedures were elective. In centres most, and do, by a 30% reduction who had not (0·62, 0·47–0·82).1 with a more restrictive approach to in term pre-eclampsia, without an Term pre-eclampsia represents caesarean delivery, this might affect increase in caesarean birth or neonatal 75–80% of disease burden, and at the acceptability and consequences of unit admission.1 least half of the associated maternal scheduled delivery. Policy for timed birth in the morbidity.5 PREVENT-PE is the first The overall benefit was modest, with UK is consistent with the norm trial to show that at 35–36 weeks’ an absolute risk reduction of 1·7%, and internationally: expectant care until gestation we can identify and prevent no difference in pre-eclampsia with an indication for birth develops, or term pre-eclampsia among those at severe features. As the timing of birth 41 weeks’ gestation is reached, when increased risk through personalised did not differ between groups (median timed birth is offered to avoid stillbirth. timed birth, an intervention available 39·4 weeks vs 39·6 weeks; p=0·70), it is In high-income countries, the average in all settings. uncertain whether the reduction is solely gestational age at birth is 39 weeks,2 We declare no competing interests. attributable to earlier scheduled birth. consistent with our trial. The similar James Goadsby, Argyro Syngelaki, The effect could also have been reduced gestational age between intervention Laura A Magee, Peter von Dadelszen, by an existing policy of scheduled birth. and usual care groups reflects that David Wright, *Kypros H Nicolaides Nevertheless, concerns should be raised timed birth is offered to a minority of kypros@fetalmedicine.com about the high rate of emergency women, consistent with personalised caesarean sections (22·8%) among a care for those who can benefit most. Fetal Medicine Research Institute, King’s College Hospital, London SE5 8BB, UK (JG, AS, KHN); predominantly low-risk population The rate of emergency caesarean Department of Women & Children’s Health, School (78%). A higher proportion of women section in the trial (22–23%) is of Life Course & Population Sciences, Faculty of Life in the intervention group were treated consistent with routinely collected Sciences & Medicine, King’s College London, London, UK (AS, LAM, PvD); Institute of Health with aspirin (17·6% vs 15·6%), a data in England (24–25%).3 The Research, University of Exeter, Exeter, UK (DW) difference that might affect estimates. apparently higher rate of elective 1 Goadsby J, Syngelaki A, Magee LA, et al. Although this study adds to evidence caesareans (22–24%) reflects the Scheduled birth at term for the prevention of supporting scheduled birth for women nature of the intervention, as women pre-eclampsia (PREVENT-PE): an open-label randomised controlled trial. Lancet 2026; at increased risk of adverse outcomes, could choose timed birth by labour 407: 67–77. 1510 --- [PDF原文](https://sci-net.xyz/storage/7932541/5a901ebfc09cab086d8b1f14bba5c87763fbe3ab833125aebe669cd4690910d4/Rocatinlimab-atopic-dermatitis-in-two-global-phase-3-clinical-trials.pdf) DOI: 10.1016/S0140-6736(26)00502-7