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221. Safety and efficacy of subcutaneous iscalimab (CFZ533) in two distinct populations of patients with Sjögren's disease (TWINSS): week 24 results of a randomised, double-blind, placebo-controlled, phase 2b dose-ranging study.
作者: Benjamin A Fisher.;Xavier Mariette.;Athena Papas.;Thomas Grader-Beck.;Hendrika Bootsma.;Wan-Fai Ng.;P L A van Daele.;Stephanie Finzel.;Ghaith Noaiseh.;Sergio Elgueta.;Josef Hermann.;Sara S McCoy.;Esen Akpek.;Arthur Bookman.;Monika Sopala.;Michela Montecchi-Palmer.;Wen-Lin Luo.;Cornelia Scheurer.;Wolfgang Hueber.; .
来源: Lancet. 2024年404卷10452期540-553页
Sjögren's disease is a chronic autoimmune disease with an unmet need for targeted therapies. The aim of the TWINSS study is to evaluate the safety and efficacy of iscalimab, a monoclonal antibody against CD40, in patients with active Sjögren's disease.
222. Molecularly guided therapy versus chemotherapy after disease control in unfavourable cancer of unknown primary (CUPISCO): an open-label, randomised, phase 2 study.
作者: Alwin Krämer.;Tilmann Bochtler.;Chantal Pauli.;Kai-Keen Shiu.;Natalie Cook.;Juliana Janoski de Menezes.;Roberto A Pazo-Cid.;Ferran Losa.;Debbie Gj Robbrecht.;Jiří Tomášek.;Cagatay Arslan.;Mustafa Özgüroğlu.;Michael Stahl.;Frédéric Bigot.;Sun Young Kim.;Yoichi Naito.;Antoine Italiano.;Nasséra Chalabi.;Gonzalo Durán-Pacheco.;Chantal Michaud.;Jeremy Scarato.;Marlene Thomas.;Jeffrey S Ross.;Holger Moch.;Linda Mileshkin.
来源: Lancet. 2024年404卷10452期527-539页
Patients with unfavourable subset cancer of unknown primary (CUP) have a poor prognosis when treated with standard platinum-based chemotherapy. Whether first-line treatment guided by comprehensive genomic profiling (CGP) can improve outcomes is unknown. The CUPISCO trial was designed to inform a molecularly guided treatment strategy to improve outcomes over standard platinum-based chemotherapy in patients with newly diagnosed, unfavourable, non-squamous CUP. The aim of the trial was to compare the efficacy and safety of molecularly guided therapy (MGT) versus standard platinum-based chemotherapy in these patients. This was to determine whether the inclusion of CGP in the initial diagnostic work-up leads to improved outcomes over the current standard of care. We herein report the primary analysis.
223. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 and ARCADIA 2): results from two replicate, double-blind, randomised controlled phase 3 trials.
作者: Jonathan I Silverberg.;Andreas Wollenberg.;Adam Reich.;Diamant Thaçi.;Franz J Legat.;Kim A Papp.;Linda Stein Gold.;Jean-David Bouaziz.;Andrew E Pink.;José Manuel Carrascosa.;Barbara Rewerska.;Jacek C Szepietowski.;Dorota Krasowska.;Blanka Havlíčková.;Monika Kalowska.;Nina Magnolo.;Sylvia Pauser.;Navid Nami.;Maxwell B Sauder.;Vipul Jain.;Kamila Padlewska.;Soo Yeon Cheong.;Patricia Fleuranceau Morel.;Liliana Ulianov.;Christophe Piketty.; .
来源: Lancet. 2024年404卷10451期445-460页
Nemolizumab, an interleukin (IL)-31 receptor subunit α antagonist, inhibits the IL-31 pathway of itch and skin inflammation in atopic dermatitis. Two international phase 3 studies were done to assess the efficacy and safety of nemolizumab in atopic dermatitis. In this Article we report results for the 16-week initial treatment period of both trials.
224. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials.
作者: Robert Bissonnette.;Richard B Warren.;Andreas Pinter.;Tove Agner.;Melinda Gooderham.;Marie L A Schuttelaar.;Marie-Noëlle Crépy.;Luca Stingeni.;Esther Serra-Baldrich.;Keith Baranowski.;Sofie Korn.;Merle Kurvits.;Ursula Plohberger.;Natacha Strange Vest.;Sibylle Schliemann.; .
来源: Lancet. 2024年404卷10451期461-473页
Chronic hand eczema is a fluctuating, inflammatory, pruritic, often painful disease of hands and wrists that strongly impacts quality of life and occupational capabilities of patients. The aim of phase 3 DELTA 1 and DELTA 2 was to assess the efficacy and safety of twice-daily applications of the topical pan-Janus kinase inhibitor delgocitinib cream 20 mg/g versus cream vehicle in adults with moderate to severe chronic hand eczema.
225. Clinical effectiveness and safety of time-lapse imaging systems for embryo incubation and selection in in-vitro fertilisation treatment (TILT): a multicentre, three-parallel-group, double-blind, randomised controlled trial.
作者: Priya Bhide.;David Y L Chan.;Doris Lanz.;Odai Alqawasmeh.;Eleanor Barry.;Dominic Baxter.;Francisco Gonzalez Carreras.;Yasmin Choudhury.;Ying Cheong.;Jacqueline Pui Wah Chung.;Bonnie Collins.;Luping Cong.;Sally Doidge.;James Heighway.;Deepali Patel.;M Carmen Pardo.;Annabel Rattos.;Annie Wright.;Julie Dodds.;Teresa Perez.;Khalid S Khan.;Shakila Thangaratinam.
来源: Lancet. 2024年404卷10449期256-265页
Time-lapse imaging systems for embryo incubation and selection might improve outcomes of in-vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI) treatment due to undisturbed embryo culture conditions, improved embryo selection, or both. However, the benefit remains uncertain. We aimed to evaluate the effectiveness of time-lapse imaging systems providing undisturbed culture and embryo selection, and time-lapse imaging systems providing only undisturbed culture, and compared each with standard care without time-lapse imaging.
226. Self-guided digital behavioural therapy versus active control for fibromyalgia (PROSPER-FM): a phase 3, multicentre, randomised controlled trial.
作者: R Michael Gendreau.;Lance M McCracken.;David A Williams.;Juan V Luciano.;Yifei Dai.;Nicolette Vega.;Zunera Ghalib.;Kristen Guthrie.;Allison C Kraus.;Michael J Rosenbluth.;Ben Vaughn.;Jennifer M Zomnir.;Dana Reddy.;Andrea L Chadwick.;Daniel J Clauw.;Lesley M Arnold.
来源: Lancet. 2024年404卷10450期364-374页
International guidelines have recommended cognitive behavioural therapy, including acceptance and commitment therapy (ACT), as it offers validated benefits for managing fibromyalgia; however, it is inaccessible to most patients. We aimed to evaluate the effect of a 12-week, self-guided, smartphone-delivered digital ACT programme on fibromyalgia management.
227. Assessing the efficacy and tolerability of PET-guided BrECADD versus eBEACOPP in advanced-stage, classical Hodgkin lymphoma (HD21): a randomised, multicentre, parallel, open-label, phase 3 trial.
作者: Peter Borchmann.;Justin Ferdinandus.;Gundolf Schneider.;Alden Moccia.;Richard Greil.;Mark Hertzberg.;Valdete Schaub.;Andreas Hüttmann.;Felix Keil.;Judith Dierlamm.;Mathias Hänel.;Urban Novak.;Julia Meissner.;Andreas Zimmermann.;Stephan Mathas.;Josée M Zijlstra.;Alexander Fosså.;Andreas Viardot.;Bernd Hertenstein.;Sonja Martin.;Pratyush Giri.;Sebastian Scholl.;Max S Topp.;Wolfram Jung.;Vladan Vucinic.;Hans-Joachim Beck.;Andrea Kerkhoff.;Benjamin Unger.;Andreas Rank.;Roland Schroers.;Christian Meyer Zum Büschenfelde.;Maike de Wit.;Karolin Trautmann-Grill.;Peter Kamper.;Daniel Molin.;Stefanie Kreissl.;Helen Kaul.;Bastian von Tresckow.;Sven Borchmann.;Karolin Behringer.;Michael Fuchs.;Andreas Rosenwald.;Wolfram Klapper.;Hans-Theodor Eich.;Christian Baues.;Athanasios Zomas.;Michael Hallek.;Markus Dietlein.;Carsten Kobe.;Volker Diehl.; .; .; .; .; .
来源: Lancet. 2024年404卷10450期341-352页
Intensified systemic chemotherapy has the highest primary cure rate for advanced-stage, classical Hodgkin lymphoma but this comes with a cost of severe and potentially life long, persisting toxicities. With the new regimen of brentuximab vedotin, etoposide, cyclophosphamide, doxorubicin, dacarbazine, and dexamethasone (BrECADD), we aimed to improve the risk-to-benefit ratio of treatment of advanced-stage, classical Hodgkin lymphoma guided by PET after two cycles.
228. Lowering systolic blood pressure to less than 120 mm Hg versus less than 140 mm Hg in patients with high cardiovascular risk with and without diabetes or previous stroke: an open-label, blinded-outcome, randomised trial.
作者: Jiamin Liu.;Yan Li.;Jinzhuo Ge.;Xiaofang Yan.;Haibo Zhang.;Xin Zheng.;Jiapeng Lu.;Xi Li.;Yan Gao.;Lubi Lei.;Jing Liu.;Jing Li.; .
来源: Lancet. 2024年404卷10449期245-255页
Uncertainty exists about whether lowering systolic blood pressure to less than 120 mm Hg is superior to that of less than 140 mm Hg, particularly in patients with diabetes and patients with previous stroke.
229. Livebirth rate after one frozen embryo transfer in ovulatory women starting with natural, modified natural, or artificial endometrial preparation in Viet Nam: an open-label randomised controlled trial.
作者: Vu N A Ho.;Toan D Pham.;Nam T Nguyen.;Rui Wang.;Robert J Norman.;Ben W Mol.;Tuong M Ho.;Lan N Vuong.
来源: Lancet. 2024年404卷10449期266-275页
Use of frozen embryo transfer (FET) in in-vitro fertilisation (IVF) has increased. However, the best endometrial preparation protocol for FET cycles is unclear. We compared natural and modified natural cycle strategies with an artificial cycle strategy for endometrial preparation before FET.
230. Effectiveness and cost-effectiveness of an individualised, progressive walking and education intervention for the prevention of low back pain recurrence in Australia (WalkBack): a randomised controlled trial.
作者: Natasha C Pocovi.;Chung-Wei Christine Lin.;Simon D French.;Petra L Graham.;Johanna M van Dongen.;Jane Latimer.;Dafna Merom.;Anne Tiedemann.;Christopher G Maher.;Ornella Clavisi.;Shuk Yin Kate Tong.;Mark J Hancock.
来源: Lancet. 2024年404卷10448期134-144页
Recurrence of low back pain is common and a substantial contributor to the disease and economic burden of low back pain. Exercise is recommended to prevent recurrence, but the effectiveness and cost-effectiveness of an accessible and low-cost intervention, such as walking, is yet to be established. We aimed to investigate the clinical effectiveness and cost-effectiveness of an individualised, progressive walking and education intervention to prevent the recurrence of low back pain.
231. Effectiveness of ferritin-guided donation intervals in whole-blood donors in the Netherlands (FIND'EM): a stepped-wedge cluster-randomised trial.
作者: Amber Meulenbeld.;Steven Ramondt.;Maike G Sweegers.;Franke A Quee.;Femmeke J Prinsze.;Emiel O Hoogendijk.;Dorine W Swinkels.;Katja van den Hurk.
来源: Lancet. 2024年404卷10447期31-43页
Whole-blood donors are at increased risk for iron deficiency and anaemia. The current standard of haemoglobin monitoring is insufficient to ensure the maintenance of proper iron reserves and donor health. We aimed to determine the effects of ferritin-guided donation intervals for blood donor health and blood supply in the Netherlands.
232. Effectiveness of a symptom-clinic intervention delivered by general practitioners with an extended role for people with multiple and persistent physical symptoms in England: the Multiple Symptoms Study 3 pragmatic, multicentre, parallel-group, individually randomised controlled trial.
作者: Christopher Burton.;Cara Mooney.;Laura Sutton.;David White.;Jeremy Dawson.;Aileen R Neilson.;Gillian Rowlands.;Steve Thomas.;Michelle Horspool.;Kate Fryer.;Monica Greco.;Tom Sanders.;Ruth E Thomas.;Cindy Cooper.;Emily Turton.;Waquas Waheed.;Jonathan Woodward.;Ellen Mallender.;Vincent Deary.
来源: Lancet. 2024年403卷10444期2619-2629页
People with multiple and persistent physical symptoms have impaired quality of life and poor experiences of health care. We aimed to evaluate the effectiveness of a community-based symptom-clinic intervention in people with multiple and persistent physical symptoms, hypothesising that this symptoms clinic plus usual care would be superior to usual care only.
233. Doublet chemotherapy, triplet chemotherapy, or doublet chemotherapy combined with radiotherapy as neoadjuvant treatment for locally advanced oesophageal cancer (JCOG1109 NExT): a randomised, controlled, open-label, phase 3 trial.
作者: Ken Kato.;Ryunosuke Machida.;Yoshinori Ito.;Hiroyuki Daiko.;Soji Ozawa.;Takashi Ogata.;Hiroki Hara.;Takashi Kojima.;Tetsuya Abe.;Takeo Bamba.;Masaya Watanabe.;Hirofumi Kawakubo.;Yuichi Shibuya.;Yasuhiro Tsubosa.;Naoki Takegawa.;Takeshi Kajiwara.;Hideo Baba.;Masaki Ueno.;Hiroya Takeuchi.;Kenichi Nakamura.;Yuko Kitagawa.; .
来源: Lancet. 2024年404卷10447期55-66页
Neoadjuvant therapy is the standard treatment for patients with locally advanced oesophageal squamous cell carcinoma (OSCC). However, the prognosis remains poor and more intensive neoadjuvant treatment might be needed to improve patient outcomes. We therefore aimed to compare the efficacy and safety of neoadjuvant doublet chemotherapy, triplet chemotherapy, and doublet chemotherapy plus radiotherapy in patients with previously untreated locally advanced OSCC.
234. Stereotactic radiotherapy for neovascular age-related macular degeneration (STAR): a pivotal, randomised, double-masked, sham-controlled device trial.
作者: Timothy L Jackson.;Riti Desai.;Hatem A Wafa.;Yanzhong Wang.;Janet Peacock.;Tunde Peto.;Usha Chakravarthy.;Helen Dakin.;Sarah Wordsworth.;Cornelius Lewis.;Patricia Clinch.;Lisa Ramazzotto.;James E Neffendorf.;Chan Ning Lee.;Joe M O'Sullivan.;Barnaby C Reeves.; .
来源: Lancet. 2024年404卷10447期44-54页
Neovascular age-related macular degeneration (nAMD) is a leading cause of blindness. The first-line therapy is anti-vascular endothelial growth factor (anti-VEGF) agents delivered by intravitreal injection. Ionising radiation mitigates key pathogenic processes underlying nAMD, and therefore has therapeutic potential. STAR aimed to assess whether stereotactic radiotherapy (SRT) reduces the number of anti-VEGF injections required, without sacrificing visual acuity.
235. Long-term colchicine for the prevention of vascular recurrent events in non-cardioembolic stroke (CONVINCE): a randomised controlled trial.
作者: Peter Kelly.;Robin Lemmens.;Christian Weimar.;Cathal Walsh.;Francisco Purroy.;Mark Barber.;Ronan Collins.;Simon Cronin.;Anna Czlonkowska.;Philippe Desfontaines.;Adinda De Pauw.;Nicholas Richard Evans.;Urs Fischer.;Catarina Fonseca.;John Forbes.;Michael D Hill.;Dalius Jatuzis.;Janika Kõrv.;Peter Kraft.;Christina Kruuse.;Catherine Lynch.;Dominick McCabe.;Robert Mikulik.;Sean Murphy.;Paul Nederkoorn.;Martin O'Donnell.;Peter Sandercock.;Bernadette Schroeder.;Gek Shim.;Katrina Tobin.;David J Williams.;Christopher Price.
来源: Lancet. 2024年404卷10448期125-133页
Anti-inflammatory therapy with long-term colchicine prevented vascular recurrence in coronary disease. Unlike coronary disease, which is typically caused by atherosclerosis, ischaemic stroke is caused by diverse mechanisms including atherosclerosis and small vessel disease or is frequently due to an unknown cause. We aimed to investigate the hypothesis that long-term colchicine would reduce recurrent events after ischaemic stroke.
236. Burr-hole drainage with or without irrigation for chronic subdural haematoma (FINISH): a Finnish, nationwide, parallel-group, multicentre, randomised, controlled, non-inferiority trial.
作者: Rahul Raj.;Pihla Tommiska.;Timo Koivisto.;Ville Leinonen.;Nils Danner.;Jussi P Posti.;Dan Laukka.;Teemu Luoto.;Minna Rauhala.;Sami Tetri.;Tommi K Korhonen.;Jarno Satopää.;Riku Kivisaari.;Teemu Luostarinen.;Christoph Schwartz.;Tomasz Czuba.;Simo Taimela.;Kimmo Lönnrot.;Teppo L N Järvinen.; .
来源: Lancet. 2024年403卷10446期2798-2806页
Chronic subdural haematoma is a common surgically treated intracranial emergency. Burr-hole drainage surgery, to evacuate chronic subdural haematoma, involves three elements: creation of a burr hole for access, irrigation of the subdural space, and insertion of a subdural drain. Although the subdural drain has been established as beneficial, the therapeutic effect of subdural irrigation has not been addressed.
237. [177Lu]Lu-DOTA-TATE plus long-acting octreotide versus high‑dose long-acting octreotide for the treatment of newly diagnosed, advanced grade 2-3, well-differentiated, gastroenteropancreatic neuroendocrine tumours (NETTER-2): an open-label, randomised, phase 3 study.
作者: Simron Singh.;Daniel Halperin.;Sten Myrehaug.;Ken Herrmann.;Marianne Pavel.;Pamela L Kunz.;Beth Chasen.;Salvatore Tafuto.;Secondo Lastoria.;Jaume Capdevila.;Amparo García-Burillo.;Do-Youn Oh.;Changhoon Yoo.;Thorvardur R Halfdanarson.;Stephen Falk.;Ilya Folitar.;Yufen Zhang.;Paola Aimone.;Wouter W de Herder.;Diego Ferone.; .
来源: Lancet. 2024年403卷10446期2807-2817页
There are currently no standard first-line treatment options for patients with higher grade 2-3, well-differentiated, advanced, gastroenteropancreatic neuroendocrine tumours. We aimed to investigate the efficacy and safety of first-line [177Lu]Lu-DOTA-TATE (177Lu-Dotatate) treatment.
238. Early versus delayed weight-bearing following operatively treated ankle fracture (WAX): a non-inferiority, multicentre, randomised controlled trial.
作者: Christopher Patrick Bretherton.;Juul Achten.;Vidoushee Jogarah.;Stavros Petrou.;Nicholas Peckham.;Felix Achana.;Duncan Appelbe.;Rebecca Kearney.;Harry Claireux.;Philip Bell.;Xavier L Griffin.; .
来源: Lancet. 2024年403卷10446期2787-2797页
After surgery for a broken ankle, patients are usually instructed to avoid walking for 6 weeks (delayed weight-bearing). Walking 2 weeks after surgery (early weight-bearing) might be a safe and preferable rehabilitation strategy. This study aimed to determine the clinical and cost effectiveness of an early weight-bearing strategy compared with a delayed weight-bearing strategy.
239. Vimseltinib versus placebo for tenosynovial giant cell tumour (MOTION): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.
作者: Hans Gelderblom.;Vivek Bhadri.;Silvia Stacchiotti.;Sebastian Bauer.;Andrew J Wagner.;Michiel van de Sande.;Nicholas M Bernthal.;Antonio López Pousa.;Albiruni Abdul Razak.;Antoine Italiano.;Mahbubl Ahmed.;Axel Le Cesne.;Gabriel Tinoco.;Kjetil Boye.;Javier Martín-Broto.;Emanuela Palmerini.;Salvatore Tafuto.;Sarah Pratap.;Benjamin C Powers.;Peter Reichardt.;Antonio Casado Herráez.;Piotr Rutkowski.;Christopher Tait.;Fiona Zarins.;Brooke Harrow.;Maitreyi G Sharma.;Rodrigo Ruiz-Soto.;Matthew L Sherman.;Jean-Yves Blay.;William D Tap.; .
来源: Lancet. 2024年403卷10445期2709-2719页
Tenosynovial giant cell tumour (TGCT) is a locally aggressive neoplasm for which few systemic treatment options exist. This study evaluated the efficacy and safety of vimseltinib, an oral, switch-control, CSF1R inhibitor, in patients with symptomatic TGCT not amenable to surgery.
240. Induction-concurrent chemoradiotherapy with or without sintilimab in patients with locoregionally advanced nasopharyngeal carcinoma in China (CONTINUUM): a multicentre, open-label, parallel-group, randomised, controlled, phase 3 trial.
作者: Xu Liu.;Yuan Zhang.;Kun-Yu Yang.;Ning Zhang.;Feng Jin.;Guo-Rong Zou.;Xiao-Dong Zhu.;Fang-Yun Xie.;Xiao-Yu Liang.;Wen-Fei Li.;Zhen-Yu He.;Nian-Yong Chen.;Wei-Han Hu.;Hai-Jun Wu.;Mei Shi.;Guan-Qun Zhou.;Yan-Ping Mao.;Rui Guo.;Rui Sun.;Jing Huang.;Shao-Qiang Liang.;Wei-Li Wu.;Zhen Su.;Ling Li.;Ping Ai.;Yu-Xiang He.;Jian Zang.;Lei Chen.;Li Lin.;Shao Hui Huang.;Cheng Xu.;Jia-Wei Lv.;Ying-Qing Li.;Shu-Bin Hong.;Yu-Sheng Jie.;Hao Li.;Sai-Wei Huang.;Ye-Lin Liang.;Ya-Qin Wang.;Ying-Lin Peng.;Jin-Han Zhu.;Sheng-Bing Zang.;Song-Ran Liu.;Qing-Guang Lin.;Hao-Jiang Li.;Li Tian.;Li-Zhi Liu.;Hong-Yun Zhao.;Ai-Hua Lin.;Ji-Bin Li.;Na Liu.;Ling-Long Tang.;Yu-Pei Chen.;Ying Sun.;Jun Ma.
来源: Lancet. 2024年403卷10445期2720-2731页
Anti-PD-1 therapy and chemotherapy is a recommended first-line treatment for recurrent or metastatic nasopharyngeal carcinoma, but the role of PD-1 blockade remains unknown in patients with locoregionally advanced nasopharyngeal carcinoma. We assessed the addition of sintilimab, a PD-1 inhibitor, to standard chemoradiotherapy in this patient population.
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