{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,4]],"date-time":"2026-03-04T17:37:11Z","timestamp":1772645831046,"version":"3.50.1"},"reference-count":23,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2026,3,4]],"date-time":"2026-03-04T00:00:00Z","timestamp":1772582400000},"content-version":"unspecified","delay-in-days":62,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004331","name":"Johnson & Johnson","doi-asserted-by":"crossref","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}],"id":[{"id":"10.13039\/100004331","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2026,1,28]]},"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To investigate the efficacy, safety, pharmacokinetics, immunogenicity and pharmacodynamics of combination therapy with nipocalimab and certolizumab in participants with active rheumatoid arthritis (RA) despite treatment with advanced therapies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this phase 2a study, participants were randomised 3:2 to receive combination therapy with nipocalimab (intravenous 30\u2009mg\/kg) and certolizumab (subcutaneous 400\u2009mg at weeks 0, 2, 4, then 200\u2009mg) or certolizumab monotherapy every 2 weeks from weeks 0 to 24. The primary endpoint was change from baseline in Disease Activity Score 28 using C-reactive protein (DAS28-CRP) at week 12. Other outcomes were assessed through week 30.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>103 participants were enrolled (combination therapy\/monotherapy, n=62\/41). At week 12, the primary endpoint was similar between groups (least squares mean 90% CI \u20131.92 (\u20132.48 to \u20131.36) vs \u20131.86 (\u20132.44 to \u20131.28); p=0.822). Secondary endpoints were also similar between groups, although numerically higher proportions of participants treated with combination therapy versus monotherapy achieved \u226550% response in American College of Rheumatology criteria (ACR50), DAS28-CRP &lt;2.6 and DAS28-CRP \u22643.2 at week 12. Serious adverse events were reported in 11.3% of participants in the combination therapy group and 2.4% in the monotherapy group. In combination with certolizumab, nipocalimab exhibited nonlinear pharmacokinetics with accelerated clearance and substantially, reversibly reduced serum immunoglobulin G, including anticitrullinated protein antibody levels.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Combination therapy of nipocalimab with certolizumab showed a similar outcome in the primary endpoint and secondary endpoints compared with certolizumab monotherapy in participants with active RA.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/rmdopen-2025-006464","type":"journal-article","created":{"date-parts":[[2026,3,4]],"date-time":"2026-03-04T14:05:20Z","timestamp":1772633120000},"page":"e006464","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Nipocalimab and certolizumab combination therapy in participants with active rheumatoid arthritis despite prior treatment with advanced therapies: results from the phase 2a DAISY-RA study"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"nct06028438","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02828046","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7766-6167","authenticated-orcid":false,"given":"Peter C","family":"Taylor","sequence":"first","affiliation":[{"name":"Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Georg","family":"Schett","sequence":"additional","affiliation":[{"name":"Department of Medicine 3 - Rheumatology and Immunology, Friedrich-Alexander-Universit\u00e4t (FAU) and Universit\u00e4tsklinikum Erlangen, Erlangen, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7033-7520","authenticated-orcid":false,"given":"Tom W J","family":"Huizinga","sequence":"additional","affiliation":[{"name":"Leiden University Medical Center, Leiden, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fowzia","family":"Ibrahim","sequence":"additional","affiliation":[{"name":"Johnson & Johnson, Wycombe, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bei","family":"Zhou","sequence":"additional","affiliation":[{"name":"Johnson & Johnson, Chesterbrook, Pennsylvania, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sicong","family":"Huang","sequence":"additional","affiliation":[{"name":"Johnson & Johnson, Cambridge, Massachusetts, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jay","family":"Gambale","sequence":"additional","affiliation":[{"name":"Johnson & Johnson, Spring House, Pennsylvania, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qingmin","family":"Wang","sequence":"additional","affiliation":[{"name":"Johnson & Johnson, Spring House, Pennsylvania, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sophia G","family":"Liva","sequence":"additional","affiliation":[{"name":"Johnson & Johnson, Spring House, Pennsylvania, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jocelyn H","family":"Leu","sequence":"additional","affiliation":[{"name":"Johnson & Johnson, Spring House, Pennsylvania, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonathan J","family":"Hubbard","sequence":"additional","affiliation":[{"name":"Johnson & Johnson, Spring House, Pennsylvania, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steven","family":"Leonardo","sequence":"additional","affiliation":[{"name":"Johnson & Johnson, Spring House, Pennsylvania, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rohit A","family":"Panchakshari","sequence":"additional","affiliation":[{"name":"Johnson & Johnson, La Jolla, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew J","family":"Loza","sequence":"additional","affiliation":[{"name":"Johnson & Johnson, Spring House, Pennsylvania, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kaiyin","family":"Fei","sequence":"additional","affiliation":[{"name":"Johnson & Johnson, Spring House, Pennsylvania, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2026,3,4]]},"reference":[{"key":"2026030406051093000_12.1.e006464.1","doi-asserted-by":"crossref","first-page":"594","DOI":"10.1016\/S2665-9913(23)00211-4","article-title":"Global, regional, and national burden of rheumatoid arthritis, 1990-2020, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021","volume":"5","year":"2023","journal-title":"Lancet Rheumatol"},{"key":"2026030406051093000_12.1.e006464.2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2018.13103"},{"key":"2026030406051093000_12.1.e006464.3","first-page":"286","article-title":"Extra-articular Manifestations in Rheumatoid Arthritis","volume":"5","author":"Cojocaru","year":"2010","journal-title":"Maedica (Bucur)"},{"key":"2026030406051093000_12.1.e006464.4","doi-asserted-by":"crossref","first-page":"95","DOI":"10.1016\/j.ejim.2024.04.026","article-title":"Incidence and predisposing factors of extra-articular manifestations in contemporary rheumatoid arthritis","volume":"126","author":"Ljung","year":"2024","journal-title":"Eur J Intern Med"},{"key":"2026030406051093000_12.1.e006464.5","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.091064"},{"key":"2026030406051093000_12.1.e006464.6","doi-asserted-by":"crossref","first-page":"357","DOI":"10.1111\/1756-185X.13513","article-title":"2018 update of the APLAR recommendations for treatment of rheumatoid arthritis","volume":"22","author":"Lau","year":"2019","journal-title":"Int J Rheum Dis"},{"key":"2026030406051093000_12.1.e006464.7","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-207524"},{"key":"2026030406051093000_12.1.e006464.8","doi-asserted-by":"crossref","first-page":"727","DOI":"10.1007\/s10067-018-4340-7","article-title":"Remission rate and predictors of remission in patients with rheumatoid arthritis under treat-to-target strategy in real-world studies: a systematic review and meta-analysis","volume":"38","author":"Yu","year":"2019","journal-title":"Clin Rheumatol"},{"key":"2026030406051093000_12.1.e006464.9","unstructured":"IMAAVY (nipocalimab-aahu) injection, for intravenous use [patient information]. Horsham, PA: Janssen Biotech, Inc; 2025."},{"key":"2026030406051093000_12.1.e006464.10","doi-asserted-by":"crossref","DOI":"10.1212\/WNL.0000000000207937","article-title":"Safety and Efficacy of Nipocalimab in Patients With Generalized Myasthenia Gravis: Results From the Randomized Phase 2 Vivacity-MG Study","volume":"102","author":"Antozzi","year":"2024","journal-title":"Neurology"},{"key":"2026030406051093000_12.1.e006464.11","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(24)00498-8"},{"key":"2026030406051093000_12.1.e006464.12","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2314466"},{"key":"2026030406051093000_12.1.e006464.13","doi-asserted-by":"crossref","first-page":"842","DOI":"10.1055\/a-2404-8089","article-title":"Design of a Phase 3, Global, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn","volume":"42","author":"Komatsu","year":"2025","journal-title":"Am J Perinatol"},{"key":"2026030406051093000_12.1.e006464.14","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.1276"},{"key":"2026030406051093000_12.1.e006464.15","doi-asserted-by":"crossref","DOI":"10.1136\/rmdopen-2024-004278","article-title":"Nipocalimab, an anti-FcRn monoclonal antibody, in participants with moderate to severe active rheumatoid arthritis and inadequate response or intolerance to anti-TNF therapy: results from the phase 2a IRIS-RA study","volume":"10","author":"Taylor","year":"2024","journal-title":"RMD Open"},{"key":"2026030406051093000_12.1.e006464.16","unstructured":"CIMZIA (certolizumab pegol) for injection, for subcutaneous use [package insert]. 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