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dc.contributor.authorLi, Zhanguo
dc.contributor.authorZhang, Fengchun
dc.contributor.authorKay, Jonathan
dc.contributor.authorFei, Kaiyin
dc.contributor.authorHan, Chenglong
dc.contributor.authorZhuang, Yanli
dc.contributor.authorWu, Zhong
dc.contributor.authorHsia, Elizabeth C.
dc.date2022-08-11T08:08:34.000
dc.date.accessioned2022-08-23T15:59:26Z
dc.date.available2022-08-23T15:59:26Z
dc.date.issued2015-08-11
dc.date.submitted2016-05-09
dc.identifier.citationInt J Rheum Dis. 2015 Aug 11. doi: 10.1111/1756-185X.12723. <a href="http://dx.doi.org/10.1111/1756-185X.12723">Link to article on publisher's site</a>
dc.identifier.issn1756-1841 (Linking)
dc.identifier.doi10.1111/1756-185X.12723
dc.identifier.pmid26259617
dc.identifier.urihttp://hdl.handle.net/20.500.14038/30667
dc.description.abstractAIM: The efficacy and safety of golimumab + methotrexate (MTX) were evaluated in Chinese patients with active rheumatoid arthritis (RA) despite MTX therapy. METHODS: Chinese patients (n = 264) were randomly assigned (1 : 1) to receive subcutaneous injections of placebo + MTX with crossover to golimumab 50 mg + MTX at week 24 (Group 1) or to golimumab 50 mg + MTX (Group 2) every 4 weeks. Group 1 patients with inadequate response entered blinded early escape to golimumab 50 mg + MTX at week 16. At least a 20% improvement in the American College of Rheumatology (ACR20) criteria at week 14 was the primary endpoint. Other assessments included the 28-joint count Disease Activity Score using C-reactive protein (DAS28-CRP) and Health Assessment Questionnaire-Disability Index (HAQ-DI) through week 52. Adverse events (AEs) were monitored through week 56. RESULTS: ACR20 response at week 14 was significantly higher in Group 2 (40.9% [54/132]) compared with Group 1 (15.9% [21/132]; P < 0.001). Greater proportions of patients in Group 2 compared with Group 1 had a DAS28-CRP response at week 14 (65.2% vs. 30.3%, P < 0.001) or ACR20 response at week 24 (42.4% vs. 15.9%, P < 0.001), and Group 2 had a significantly greater change in HAQ-DI at week 24 (-0.26 vs. 0.15, P < 0.001). After week 24, the proportion of patients achieving ACR20 in Group 1 approached that in Group 2. Through week 16, 23.5% of Group 1 and 26.7% of Group 2 patients reported AEs. Among golimumab + MTX-treated patients, 50.2% and 4.2% had > /= 1 AE or serious AE, respectively, through week 56. No unexpected safety signals were observed. CONCLUSION: Among MTX-experienced Chinese patients with active RA, a significantly greater proportion of patients receiving golimumab + MTX had improvements in the signs and symptoms of RA compared with MTX monotherapy. Safety findings were consistent with previous studies of golimumab in patients with RA.
dc.language.isoen_US
dc.relation<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=26259617&dopt=Abstract">Link to Article in PubMed</a>
dc.relation.urlhttp://dx.doi.org/10.1111/1756-185X.12723
dc.subjectAsian
dc.subjectanti-tumor necrosis factor
dc.subjectbiologics
dc.subjectrheumatoid arthritis
dc.subjectMusculoskeletal Diseases
dc.subjectRheumatology
dc.titleEfficacy and safety results from a Phase 3, randomized, placebo-controlled trial of subcutaneous golimumab in Chinese patients with active rheumatoid arthritis despite methotrexate therapy
dc.typeJournal Article
dc.source.journaltitleInternational journal of rheumatic diseases
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/faculty_pubs/945
dc.identifier.contextkey8575157
html.description.abstract<p>AIM: The efficacy and safety of golimumab + methotrexate (MTX) were evaluated in Chinese patients with active rheumatoid arthritis (RA) despite MTX therapy.</p> <p>METHODS: Chinese patients (n = 264) were randomly assigned (1 : 1) to receive subcutaneous injections of placebo + MTX with crossover to golimumab 50 mg + MTX at week 24 (Group 1) or to golimumab 50 mg + MTX (Group 2) every 4 weeks. Group 1 patients with inadequate response entered blinded early escape to golimumab 50 mg + MTX at week 16. At least a 20% improvement in the American College of Rheumatology (ACR20) criteria at week 14 was the primary endpoint. Other assessments included the 28-joint count Disease Activity Score using C-reactive protein (DAS28-CRP) and Health Assessment Questionnaire-Disability Index (HAQ-DI) through week 52. Adverse events (AEs) were monitored through week 56.</p> <p>RESULTS: ACR20 response at week 14 was significantly higher in Group 2 (40.9% [54/132]) compared with Group 1 (15.9% [21/132]; P < 0.001). Greater proportions of patients in Group 2 compared with Group 1 had a DAS28-CRP response at week 14 (65.2% vs. 30.3%, P < 0.001) or ACR20 response at week 24 (42.4% vs. 15.9%, P < 0.001), and Group 2 had a significantly greater change in HAQ-DI at week 24 (-0.26 vs. 0.15, P < 0.001). After week 24, the proportion of patients achieving ACR20 in Group 1 approached that in Group 2. Through week 16, 23.5% of Group 1 and 26.7% of Group 2 patients reported AEs. Among golimumab + MTX-treated patients, 50.2% and 4.2% had > /= 1 AE or serious AE, respectively, through week 56. No unexpected safety signals were observed.</p> <p>CONCLUSION: Among MTX-experienced Chinese patients with active RA, a significantly greater proportion of patients receiving golimumab + MTX had improvements in the signs and symptoms of RA compared with MTX monotherapy. Safety findings were consistent with previous studies of golimumab in patients with RA.</p>
dc.identifier.submissionpathfaculty_pubs/945
dc.contributor.departmentDepartment of Medicine, Division of Rheumatology


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