Efficacy 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.contributor.author | Li, Zhanguo | |
dc.contributor.author | Zhang, Fengchun | |
dc.contributor.author | Kay, Jonathan | |
dc.contributor.author | Fei, Kaiyin | |
dc.contributor.author | Han, Chenglong | |
dc.contributor.author | Zhuang, Yanli | |
dc.contributor.author | Wu, Zhong | |
dc.contributor.author | Hsia, Elizabeth C. | |
dc.date | 2022-08-11T08:08:34.000 | |
dc.date.accessioned | 2022-08-23T15:59:26Z | |
dc.date.available | 2022-08-23T15:59:26Z | |
dc.date.issued | 2015-08-11 | |
dc.date.submitted | 2016-05-09 | |
dc.identifier.citation | Int 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.issn | 1756-1841 (Linking) | |
dc.identifier.doi | 10.1111/1756-185X.12723 | |
dc.identifier.pmid | 26259617 | |
dc.identifier.uri | http://hdl.handle.net/20.500.14038/30667 | |
dc.description.abstract | AIM: 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.iso | en_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.url | http://dx.doi.org/10.1111/1756-185X.12723 | |
dc.subject | Asian | |
dc.subject | anti-tumor necrosis factor | |
dc.subject | biologics | |
dc.subject | rheumatoid arthritis | |
dc.subject | Musculoskeletal Diseases | |
dc.subject | Rheumatology | |
dc.title | Efficacy 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.type | Journal Article | |
dc.source.journaltitle | International journal of rheumatic diseases | |
dc.identifier.legacycoverpage | https://escholarship.umassmed.edu/faculty_pubs/945 | |
dc.identifier.contextkey | 8575157 | |
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.submissionpath | faculty_pubs/945 | |
dc.contributor.department | Department of Medicine, Division of Rheumatology |