Safety of combination therapy with two bDMARDs in patients with rheumatoid arthritis: A systematic review and meta-analysis
Objectives: We performed a systematic review and meta-analysis of the current literature to assess the safety of combining two biologic disease-modifying antirheumatic drugs (bDMARDs) in the treatment of rheumatoid arthritis (RA).Methods: We systematically searched for controlled studies evaluating...
Ausführliche Beschreibung
Autor*in: |
Boleto, Gonçalo [verfasserIn] Kanagaratnam, Lukshe [verfasserIn] Dramé, Moustapha [verfasserIn] Salmon, Jean-Hugues [verfasserIn] |
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Format: |
E-Artikel |
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Sprache: |
Englisch |
Erschienen: |
2018 |
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Schlagwörter: |
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Übergeordnetes Werk: |
Enthalten in: Seminars in arthritis and rheumatism - Philadelphia, Pa. : Saunders, 1971, 49, Seite 35-42 |
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Übergeordnetes Werk: |
volume:49 ; pages:35-42 |
DOI / URN: |
10.1016/j.semarthrit.2018.12.003 |
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Katalog-ID: |
ELV002585030 |
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520 | |a Objectives: We performed a systematic review and meta-analysis of the current literature to assess the safety of combining two biologic disease-modifying antirheumatic drugs (bDMARDs) in the treatment of rheumatoid arthritis (RA).Methods: We systematically searched for controlled studies evaluating safety in patients with RA treated with two bDMARDs independently of dose-regimen. Databases used were MEDLINE (via Pubmed), EMBase, Cochrane Library, Scopus, ClinicalTrials.gov, and the WHO International Clinical Trials Registry platform. A meta-analysis was performed between groups on combination therapy and patients on single therapy using random effects model calculating odds ratio (OR) as well as 95% confidence interval (CI). The primary outcome was the rate of serious adverse events (SAEs).Results: Six studies with a total of 623 patients (410 on combination therapy and 213 on single therapy) were included. Median follow-up was 9.5 months (range 6–12 months). There was a significant increase in SAEs in the combination group (14.9 vs 6.0%, OR 2.51, 95% CI 1.29–4.89, I2 0%) as well as in total adverse events (94.6 vs 89.1%, OR 2.07, 95% CI 1.11–3.86, I2 0%). When performing subgroup analysis in patients receiving only full-dose of both bDMARDs there was a significant increase in serious infections (6.7 vs 0.6%, OR 5.58, 95% CI 1.25–24.90, I2 0%) and the risk of SAEs remained significantly higher (17.1 vs 6.2%, OR 2.72, 95% CI 1.30–5.69, I2 0%).Conclusion: Our findings suggest that combination therapy with two bDMARDs in RA appears to increase the risk of SAEs during the first twelve months of treatment. | ||
650 | 4 | |a Rheumatoid arthritis-drug therapy | |
650 | 4 | |a Drug tolerance | |
650 | 4 | |a Drug therapy, Combination | |
650 | 4 | |a Meta-analysis as topic | |
700 | 1 | |a Kanagaratnam, Lukshe |e verfasserin |4 aut | |
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10.1016/j.semarthrit.2018.12.003 doi (DE-627)ELV002585030 (ELSEVIER)S0049-0172(18)30653-X DE-627 ger DE-627 rda eng 610 DE-600 44.83 bkl Boleto, Gonçalo verfasserin aut Safety of combination therapy with two bDMARDs in patients with rheumatoid arthritis: A systematic review and meta-analysis 2018 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objectives: We performed a systematic review and meta-analysis of the current literature to assess the safety of combining two biologic disease-modifying antirheumatic drugs (bDMARDs) in the treatment of rheumatoid arthritis (RA).Methods: We systematically searched for controlled studies evaluating safety in patients with RA treated with two bDMARDs independently of dose-regimen. Databases used were MEDLINE (via Pubmed), EMBase, Cochrane Library, Scopus, ClinicalTrials.gov, and the WHO International Clinical Trials Registry platform. A meta-analysis was performed between groups on combination therapy and patients on single therapy using random effects model calculating odds ratio (OR) as well as 95% confidence interval (CI). The primary outcome was the rate of serious adverse events (SAEs).Results: Six studies with a total of 623 patients (410 on combination therapy and 213 on single therapy) were included. Median follow-up was 9.5 months (range 6–12 months). There was a significant increase in SAEs in the combination group (14.9 vs 6.0%, OR 2.51, 95% CI 1.29–4.89, I2 0%) as well as in total adverse events (94.6 vs 89.1%, OR 2.07, 95% CI 1.11–3.86, I2 0%). When performing subgroup analysis in patients receiving only full-dose of both bDMARDs there was a significant increase in serious infections (6.7 vs 0.6%, OR 5.58, 95% CI 1.25–24.90, I2 0%) and the risk of SAEs remained significantly higher (17.1 vs 6.2%, OR 2.72, 95% CI 1.30–5.69, I2 0%).Conclusion: Our findings suggest that combination therapy with two bDMARDs in RA appears to increase the risk of SAEs during the first twelve months of treatment. Rheumatoid arthritis-drug therapy Drug tolerance Drug therapy, Combination Meta-analysis as topic Kanagaratnam, Lukshe verfasserin aut Dramé, Moustapha verfasserin aut Salmon, Jean-Hugues verfasserin (orcid)0000-0002-1003-6061 aut Enthalten in Seminars in arthritis and rheumatism Philadelphia, Pa. : Saunders, 1971 49, Seite 35-42 Online-Ressource (DE-627)330079441 (DE-600)2048942-0 (DE-576)097935018 1532-866X nnns volume:49 pages:35-42 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2336 GBV_ILN_4037 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4313 GBV_ILN_4326 GBV_ILN_4334 GBV_ILN_4338 44.83 Rheumatologie Orthopädie AR 49 35-42 |
spelling |
10.1016/j.semarthrit.2018.12.003 doi (DE-627)ELV002585030 (ELSEVIER)S0049-0172(18)30653-X DE-627 ger DE-627 rda eng 610 DE-600 44.83 bkl Boleto, Gonçalo verfasserin aut Safety of combination therapy with two bDMARDs in patients with rheumatoid arthritis: A systematic review and meta-analysis 2018 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objectives: We performed a systematic review and meta-analysis of the current literature to assess the safety of combining two biologic disease-modifying antirheumatic drugs (bDMARDs) in the treatment of rheumatoid arthritis (RA).Methods: We systematically searched for controlled studies evaluating safety in patients with RA treated with two bDMARDs independently of dose-regimen. Databases used were MEDLINE (via Pubmed), EMBase, Cochrane Library, Scopus, ClinicalTrials.gov, and the WHO International Clinical Trials Registry platform. A meta-analysis was performed between groups on combination therapy and patients on single therapy using random effects model calculating odds ratio (OR) as well as 95% confidence interval (CI). The primary outcome was the rate of serious adverse events (SAEs).Results: Six studies with a total of 623 patients (410 on combination therapy and 213 on single therapy) were included. Median follow-up was 9.5 months (range 6–12 months). There was a significant increase in SAEs in the combination group (14.9 vs 6.0%, OR 2.51, 95% CI 1.29–4.89, I2 0%) as well as in total adverse events (94.6 vs 89.1%, OR 2.07, 95% CI 1.11–3.86, I2 0%). When performing subgroup analysis in patients receiving only full-dose of both bDMARDs there was a significant increase in serious infections (6.7 vs 0.6%, OR 5.58, 95% CI 1.25–24.90, I2 0%) and the risk of SAEs remained significantly higher (17.1 vs 6.2%, OR 2.72, 95% CI 1.30–5.69, I2 0%).Conclusion: Our findings suggest that combination therapy with two bDMARDs in RA appears to increase the risk of SAEs during the first twelve months of treatment. Rheumatoid arthritis-drug therapy Drug tolerance Drug therapy, Combination Meta-analysis as topic Kanagaratnam, Lukshe verfasserin aut Dramé, Moustapha verfasserin aut Salmon, Jean-Hugues verfasserin (orcid)0000-0002-1003-6061 aut Enthalten in Seminars in arthritis and rheumatism Philadelphia, Pa. : Saunders, 1971 49, Seite 35-42 Online-Ressource (DE-627)330079441 (DE-600)2048942-0 (DE-576)097935018 1532-866X nnns volume:49 pages:35-42 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2336 GBV_ILN_4037 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4313 GBV_ILN_4326 GBV_ILN_4334 GBV_ILN_4338 44.83 Rheumatologie Orthopädie AR 49 35-42 |
allfields_unstemmed |
10.1016/j.semarthrit.2018.12.003 doi (DE-627)ELV002585030 (ELSEVIER)S0049-0172(18)30653-X DE-627 ger DE-627 rda eng 610 DE-600 44.83 bkl Boleto, Gonçalo verfasserin aut Safety of combination therapy with two bDMARDs in patients with rheumatoid arthritis: A systematic review and meta-analysis 2018 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objectives: We performed a systematic review and meta-analysis of the current literature to assess the safety of combining two biologic disease-modifying antirheumatic drugs (bDMARDs) in the treatment of rheumatoid arthritis (RA).Methods: We systematically searched for controlled studies evaluating safety in patients with RA treated with two bDMARDs independently of dose-regimen. Databases used were MEDLINE (via Pubmed), EMBase, Cochrane Library, Scopus, ClinicalTrials.gov, and the WHO International Clinical Trials Registry platform. A meta-analysis was performed between groups on combination therapy and patients on single therapy using random effects model calculating odds ratio (OR) as well as 95% confidence interval (CI). The primary outcome was the rate of serious adverse events (SAEs).Results: Six studies with a total of 623 patients (410 on combination therapy and 213 on single therapy) were included. Median follow-up was 9.5 months (range 6–12 months). There was a significant increase in SAEs in the combination group (14.9 vs 6.0%, OR 2.51, 95% CI 1.29–4.89, I2 0%) as well as in total adverse events (94.6 vs 89.1%, OR 2.07, 95% CI 1.11–3.86, I2 0%). When performing subgroup analysis in patients receiving only full-dose of both bDMARDs there was a significant increase in serious infections (6.7 vs 0.6%, OR 5.58, 95% CI 1.25–24.90, I2 0%) and the risk of SAEs remained significantly higher (17.1 vs 6.2%, OR 2.72, 95% CI 1.30–5.69, I2 0%).Conclusion: Our findings suggest that combination therapy with two bDMARDs in RA appears to increase the risk of SAEs during the first twelve months of treatment. Rheumatoid arthritis-drug therapy Drug tolerance Drug therapy, Combination Meta-analysis as topic Kanagaratnam, Lukshe verfasserin aut Dramé, Moustapha verfasserin aut Salmon, Jean-Hugues verfasserin (orcid)0000-0002-1003-6061 aut Enthalten in Seminars in arthritis and rheumatism Philadelphia, Pa. : Saunders, 1971 49, Seite 35-42 Online-Ressource (DE-627)330079441 (DE-600)2048942-0 (DE-576)097935018 1532-866X nnns volume:49 pages:35-42 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2336 GBV_ILN_4037 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4313 GBV_ILN_4326 GBV_ILN_4334 GBV_ILN_4338 44.83 Rheumatologie Orthopädie AR 49 35-42 |
allfieldsGer |
10.1016/j.semarthrit.2018.12.003 doi (DE-627)ELV002585030 (ELSEVIER)S0049-0172(18)30653-X DE-627 ger DE-627 rda eng 610 DE-600 44.83 bkl Boleto, Gonçalo verfasserin aut Safety of combination therapy with two bDMARDs in patients with rheumatoid arthritis: A systematic review and meta-analysis 2018 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objectives: We performed a systematic review and meta-analysis of the current literature to assess the safety of combining two biologic disease-modifying antirheumatic drugs (bDMARDs) in the treatment of rheumatoid arthritis (RA).Methods: We systematically searched for controlled studies evaluating safety in patients with RA treated with two bDMARDs independently of dose-regimen. Databases used were MEDLINE (via Pubmed), EMBase, Cochrane Library, Scopus, ClinicalTrials.gov, and the WHO International Clinical Trials Registry platform. A meta-analysis was performed between groups on combination therapy and patients on single therapy using random effects model calculating odds ratio (OR) as well as 95% confidence interval (CI). The primary outcome was the rate of serious adverse events (SAEs).Results: Six studies with a total of 623 patients (410 on combination therapy and 213 on single therapy) were included. Median follow-up was 9.5 months (range 6–12 months). There was a significant increase in SAEs in the combination group (14.9 vs 6.0%, OR 2.51, 95% CI 1.29–4.89, I2 0%) as well as in total adverse events (94.6 vs 89.1%, OR 2.07, 95% CI 1.11–3.86, I2 0%). When performing subgroup analysis in patients receiving only full-dose of both bDMARDs there was a significant increase in serious infections (6.7 vs 0.6%, OR 5.58, 95% CI 1.25–24.90, I2 0%) and the risk of SAEs remained significantly higher (17.1 vs 6.2%, OR 2.72, 95% CI 1.30–5.69, I2 0%).Conclusion: Our findings suggest that combination therapy with two bDMARDs in RA appears to increase the risk of SAEs during the first twelve months of treatment. Rheumatoid arthritis-drug therapy Drug tolerance Drug therapy, Combination Meta-analysis as topic Kanagaratnam, Lukshe verfasserin aut Dramé, Moustapha verfasserin aut Salmon, Jean-Hugues verfasserin (orcid)0000-0002-1003-6061 aut Enthalten in Seminars in arthritis and rheumatism Philadelphia, Pa. : Saunders, 1971 49, Seite 35-42 Online-Ressource (DE-627)330079441 (DE-600)2048942-0 (DE-576)097935018 1532-866X nnns volume:49 pages:35-42 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2336 GBV_ILN_4037 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4313 GBV_ILN_4326 GBV_ILN_4334 GBV_ILN_4338 44.83 Rheumatologie Orthopädie AR 49 35-42 |
allfieldsSound |
10.1016/j.semarthrit.2018.12.003 doi (DE-627)ELV002585030 (ELSEVIER)S0049-0172(18)30653-X DE-627 ger DE-627 rda eng 610 DE-600 44.83 bkl Boleto, Gonçalo verfasserin aut Safety of combination therapy with two bDMARDs in patients with rheumatoid arthritis: A systematic review and meta-analysis 2018 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objectives: We performed a systematic review and meta-analysis of the current literature to assess the safety of combining two biologic disease-modifying antirheumatic drugs (bDMARDs) in the treatment of rheumatoid arthritis (RA).Methods: We systematically searched for controlled studies evaluating safety in patients with RA treated with two bDMARDs independently of dose-regimen. Databases used were MEDLINE (via Pubmed), EMBase, Cochrane Library, Scopus, ClinicalTrials.gov, and the WHO International Clinical Trials Registry platform. A meta-analysis was performed between groups on combination therapy and patients on single therapy using random effects model calculating odds ratio (OR) as well as 95% confidence interval (CI). The primary outcome was the rate of serious adverse events (SAEs).Results: Six studies with a total of 623 patients (410 on combination therapy and 213 on single therapy) were included. Median follow-up was 9.5 months (range 6–12 months). There was a significant increase in SAEs in the combination group (14.9 vs 6.0%, OR 2.51, 95% CI 1.29–4.89, I2 0%) as well as in total adverse events (94.6 vs 89.1%, OR 2.07, 95% CI 1.11–3.86, I2 0%). When performing subgroup analysis in patients receiving only full-dose of both bDMARDs there was a significant increase in serious infections (6.7 vs 0.6%, OR 5.58, 95% CI 1.25–24.90, I2 0%) and the risk of SAEs remained significantly higher (17.1 vs 6.2%, OR 2.72, 95% CI 1.30–5.69, I2 0%).Conclusion: Our findings suggest that combination therapy with two bDMARDs in RA appears to increase the risk of SAEs during the first twelve months of treatment. Rheumatoid arthritis-drug therapy Drug tolerance Drug therapy, Combination Meta-analysis as topic Kanagaratnam, Lukshe verfasserin aut Dramé, Moustapha verfasserin aut Salmon, Jean-Hugues verfasserin (orcid)0000-0002-1003-6061 aut Enthalten in Seminars in arthritis and rheumatism Philadelphia, Pa. : Saunders, 1971 49, Seite 35-42 Online-Ressource (DE-627)330079441 (DE-600)2048942-0 (DE-576)097935018 1532-866X nnns volume:49 pages:35-42 GBV_USEFLAG_U SYSFLAG_U GBV_ELV SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2034 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2336 GBV_ILN_4037 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4313 GBV_ILN_4326 GBV_ILN_4334 GBV_ILN_4338 44.83 Rheumatologie Orthopädie AR 49 35-42 |
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safety of combination therapy with two bdmards in patients with rheumatoid arthritis: a systematic review and meta-analysis |
title_auth |
Safety of combination therapy with two bDMARDs in patients with rheumatoid arthritis: A systematic review and meta-analysis |
abstract |
Objectives: We performed a systematic review and meta-analysis of the current literature to assess the safety of combining two biologic disease-modifying antirheumatic drugs (bDMARDs) in the treatment of rheumatoid arthritis (RA).Methods: We systematically searched for controlled studies evaluating safety in patients with RA treated with two bDMARDs independently of dose-regimen. Databases used were MEDLINE (via Pubmed), EMBase, Cochrane Library, Scopus, ClinicalTrials.gov, and the WHO International Clinical Trials Registry platform. A meta-analysis was performed between groups on combination therapy and patients on single therapy using random effects model calculating odds ratio (OR) as well as 95% confidence interval (CI). The primary outcome was the rate of serious adverse events (SAEs).Results: Six studies with a total of 623 patients (410 on combination therapy and 213 on single therapy) were included. Median follow-up was 9.5 months (range 6–12 months). There was a significant increase in SAEs in the combination group (14.9 vs 6.0%, OR 2.51, 95% CI 1.29–4.89, I2 0%) as well as in total adverse events (94.6 vs 89.1%, OR 2.07, 95% CI 1.11–3.86, I2 0%). When performing subgroup analysis in patients receiving only full-dose of both bDMARDs there was a significant increase in serious infections (6.7 vs 0.6%, OR 5.58, 95% CI 1.25–24.90, I2 0%) and the risk of SAEs remained significantly higher (17.1 vs 6.2%, OR 2.72, 95% CI 1.30–5.69, I2 0%).Conclusion: Our findings suggest that combination therapy with two bDMARDs in RA appears to increase the risk of SAEs during the first twelve months of treatment. |
abstractGer |
Objectives: We performed a systematic review and meta-analysis of the current literature to assess the safety of combining two biologic disease-modifying antirheumatic drugs (bDMARDs) in the treatment of rheumatoid arthritis (RA).Methods: We systematically searched for controlled studies evaluating safety in patients with RA treated with two bDMARDs independently of dose-regimen. Databases used were MEDLINE (via Pubmed), EMBase, Cochrane Library, Scopus, ClinicalTrials.gov, and the WHO International Clinical Trials Registry platform. A meta-analysis was performed between groups on combination therapy and patients on single therapy using random effects model calculating odds ratio (OR) as well as 95% confidence interval (CI). The primary outcome was the rate of serious adverse events (SAEs).Results: Six studies with a total of 623 patients (410 on combination therapy and 213 on single therapy) were included. Median follow-up was 9.5 months (range 6–12 months). There was a significant increase in SAEs in the combination group (14.9 vs 6.0%, OR 2.51, 95% CI 1.29–4.89, I2 0%) as well as in total adverse events (94.6 vs 89.1%, OR 2.07, 95% CI 1.11–3.86, I2 0%). When performing subgroup analysis in patients receiving only full-dose of both bDMARDs there was a significant increase in serious infections (6.7 vs 0.6%, OR 5.58, 95% CI 1.25–24.90, I2 0%) and the risk of SAEs remained significantly higher (17.1 vs 6.2%, OR 2.72, 95% CI 1.30–5.69, I2 0%).Conclusion: Our findings suggest that combination therapy with two bDMARDs in RA appears to increase the risk of SAEs during the first twelve months of treatment. |
abstract_unstemmed |
Objectives: We performed a systematic review and meta-analysis of the current literature to assess the safety of combining two biologic disease-modifying antirheumatic drugs (bDMARDs) in the treatment of rheumatoid arthritis (RA).Methods: We systematically searched for controlled studies evaluating safety in patients with RA treated with two bDMARDs independently of dose-regimen. Databases used were MEDLINE (via Pubmed), EMBase, Cochrane Library, Scopus, ClinicalTrials.gov, and the WHO International Clinical Trials Registry platform. A meta-analysis was performed between groups on combination therapy and patients on single therapy using random effects model calculating odds ratio (OR) as well as 95% confidence interval (CI). The primary outcome was the rate of serious adverse events (SAEs).Results: Six studies with a total of 623 patients (410 on combination therapy and 213 on single therapy) were included. Median follow-up was 9.5 months (range 6–12 months). There was a significant increase in SAEs in the combination group (14.9 vs 6.0%, OR 2.51, 95% CI 1.29–4.89, I2 0%) as well as in total adverse events (94.6 vs 89.1%, OR 2.07, 95% CI 1.11–3.86, I2 0%). When performing subgroup analysis in patients receiving only full-dose of both bDMARDs there was a significant increase in serious infections (6.7 vs 0.6%, OR 5.58, 95% CI 1.25–24.90, I2 0%) and the risk of SAEs remained significantly higher (17.1 vs 6.2%, OR 2.72, 95% CI 1.30–5.69, I2 0%).Conclusion: Our findings suggest that combination therapy with two bDMARDs in RA appears to increase the risk of SAEs during the first twelve months of treatment. |
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Databases used were MEDLINE (via Pubmed), EMBase, Cochrane Library, Scopus, ClinicalTrials.gov, and the WHO International Clinical Trials Registry platform. A meta-analysis was performed between groups on combination therapy and patients on single therapy using random effects model calculating odds ratio (OR) as well as 95% confidence interval (CI). The primary outcome was the rate of serious adverse events (SAEs).Results: Six studies with a total of 623 patients (410 on combination therapy and 213 on single therapy) were included. Median follow-up was 9.5 months (range 6–12 months). There was a significant increase in SAEs in the combination group (14.9 vs 6.0%, OR 2.51, 95% CI 1.29–4.89, I2 0%) as well as in total adverse events (94.6 vs 89.1%, OR 2.07, 95% CI 1.11–3.86, I2 0%). When performing subgroup analysis in patients receiving only full-dose of both bDMARDs there was a significant increase in serious infections (6.7 vs 0.6%, OR 5.58, 95% CI 1.25–24.90, I2 0%) and the risk of SAEs remained significantly higher (17.1 vs 6.2%, OR 2.72, 95% CI 1.30–5.69, I2 0%).Conclusion: Our findings suggest that combination therapy with two bDMARDs in RA appears to increase the risk of SAEs during the first twelve months of treatment.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Rheumatoid arthritis-drug therapy</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Drug tolerance</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Drug therapy, Combination</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Meta-analysis as topic</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Kanagaratnam, Lukshe</subfield><subfield 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