{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T23:10:59Z","timestamp":1790205059434,"version":"4.1.0"},"reference-count":17,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2024,3,25]],"date-time":"2024-03-25T00:00:00Z","timestamp":1711324800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/501100001350","name":"Singapore Ministry of Health","doi-asserted-by":"crossref","award":["NMRC\/CIRG\/1322\/2012"],"award-info":[{"award-number":["NMRC\/CIRG\/1322\/2012"]}],"id":[{"id":"10.13039\/501100001350","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100004330","name":"GSK","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004330","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,9,23]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Interleukin 4 (IL-4), increased in tuberculosis infection, may impair bacterial killing. Blocking IL-4 confers benefit in animal models. We evaluated safety and efficacy of pascolizumab (humanized anti\u2013IL-4 monoclonal antibody) as adjunctive tuberculosis treatment.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Participants with rifampicin-susceptible pulmonary tuberculosis received a single intravenous infusion of pascolizumab or placebo, and standard 6-month tuberculosis treatment. Pascolizumab dose increased in successive cohorts: (1) nonrandomized 0.05\u2005mg\/kg (n = 4); (2) nonrandomized 0.5\u2005mg\/kg (n = 4); (3) randomized 2.5\u2005mg\/kg (n = 9) or placebo (n = 3); and (4) randomized 10\u2005mg\/kg (n = 9) or placebo (n = 3). Coprimary safety outcome was study-drug\u2013related grade 4 or serious adverse event (G4\/SAE) in all cohorts (1\u20134). Coprimary efficacy outcome was week 8 sputum culture time-to-positivity (TTP) in randomized cohorts (3\u20134) combined.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Pascolizumab levels exceeded IL-4 50% neutralizing dose for 8 weeks in 78%\u2013100% of participants in cohorts 3\u20134. There were no study-drug\u2013related G4\/SAEs. Median week-8 TTP was 42 days in pascolizumab and placebo groups (P = .185). Rate of TTP increase was greater with pascolizumab (difference from placebo 0.011 log10 TTP\/day; 95% Bayesian credible interval 0.006 to 0.015 log10 TTP\/day).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>There was no evidence to suggest blocking IL-4 was unsafe. Preliminary efficacy findings are consistent with animal models. This supports further investigation of adjunctive anti\u2013IL-4 interventions for tuberculosis in larger phase 2 trials.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>NCT 01638520.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/infdis\/jiae104","type":"journal-article","created":{"date-parts":[[2024,3,26]],"date-time":"2024-03-26T01:53:05Z","timestamp":1711417985000},"page":"590-597","source":"Crossref","is-referenced-by-count":5,"title":["Adjunctive Pascolizumab in Rifampicin-Susceptible Pulmonary Tuberculosis: Proof-of-Concept, Partially-Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Trial"],"prefix":"10.1093","volume":"230","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7003-9838","authenticated-orcid":false,"given":"Nicholas I","family":"Paton","sequence":"first","affiliation":[{"name":"Department of Medicine, Yong Loo Lin School of 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