Tofacitinib Efficacy in Patients with Rheumatoid Arthritis and Probable Depression/Anxiety : Post Hoc Analysis of Phase 3 and 3b/4 Randomized Controlled Trials
© 2023. The Author(s)..
INTRODUCTION: The aim of our work is to assess the prevalence of probable major depressive disorder and/or probable generalized anxiety disorder (pMDD/pGAD) in patients with moderate to severe rheumatoid arthritis (RA), and to evaluate the efficacy of tofacitinib on RA symptoms stratified by baseline pMDD/pGAD status.
METHODS: Data were pooled from five phase 3 randomized controlled trials (RCTs) and one phase 3b/4 RCT, assessing tofacitinib 5 or 10 mg twice daily (BID), adalimumab (two RCTs), or placebo. pMDD/pGAD was defined as Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) score ≤ 38. Efficacy outcomes over 12 months included least squares mean change from baseline in SF-36 MCS score and Health Assessment Questionnaire-Disability Index, proportions of patients with pMDD/pGAD in those with baseline pMDD/pGAD, and American College of Rheumatology 20/50/70 response, and Disease Activity Score in 28 joints, erythrocyte sedimentation rate remission (< 2.6) rates.
RESULTS: A total of 4404 patients with non-missing baseline values were included. Baseline pMDD/pGAD was reported by 44.5%, 39.8%, 45.4%, and 39.1% of patients receiving tofacitinib 5 mg BID, tofacitinib 10 mg BID, adalimumab, and placebo, respectively. SF-36 MCS improvements were greater for tofacitinib versus adalimumab/placebo through month 6, with numerical improvements for tofacitinib versus adalimumab sustained through month 12, when the proportions of patients with baseline pMDD/pGAD who continued to have pMDD/pGAD were reduced. RA efficacy outcomes were generally similar in patients with/without baseline pMDD/pGAD.
CONCLUSIONS: The percentage of patients with pMDD/pGAD reduced from baseline over 1 year of treatment with tofacitinib or adalimumab. Effective treatment of underlying RA may lead to improvements in depression and anxiety, based on the SF-36 MCS. Specially designed studies using gold-standard diagnostic tools would be warranted to investigate this further. Video Abstract available for this article.
TRIAL REGISTRATION: NCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385, NCT02187055. Video Abstract (MP4 204475 KB).
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:11 |
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| Enthalten in: |
Rheumatology and therapy - 11(2024), 1 vom: 19. Jan., Seite 35-50 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Citera, Gustavo [VerfasserIn] |
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| Links: |
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| Themen: |
Anxiety |
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| Anmerkungen: |
Date Revised 21.01.2024 published: Print-Electronic ClinicalTrials.gov: NCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385, NCT02187055 Citation Status PubMed-not-MEDLINE |
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| doi: |
10.1007/s40744-023-00612-7 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM364175095 |
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| 245 | 1 | 0 | |a Tofacitinib Efficacy in Patients with Rheumatoid Arthritis and Probable Depression/Anxiety |b Post Hoc Analysis of Phase 3 and 3b/4 Randomized Controlled Trials |
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| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385, NCT02187055 | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a © 2023. The Author(s). | ||
| 520 | |a INTRODUCTION: The aim of our work is to assess the prevalence of probable major depressive disorder and/or probable generalized anxiety disorder (pMDD/pGAD) in patients with moderate to severe rheumatoid arthritis (RA), and to evaluate the efficacy of tofacitinib on RA symptoms stratified by baseline pMDD/pGAD status | ||
| 520 | |a METHODS: Data were pooled from five phase 3 randomized controlled trials (RCTs) and one phase 3b/4 RCT, assessing tofacitinib 5 or 10 mg twice daily (BID), adalimumab (two RCTs), or placebo. pMDD/pGAD was defined as Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) score ≤ 38. Efficacy outcomes over 12 months included least squares mean change from baseline in SF-36 MCS score and Health Assessment Questionnaire-Disability Index, proportions of patients with pMDD/pGAD in those with baseline pMDD/pGAD, and American College of Rheumatology 20/50/70 response, and Disease Activity Score in 28 joints, erythrocyte sedimentation rate remission (< 2.6) rates | ||
| 520 | |a RESULTS: A total of 4404 patients with non-missing baseline values were included. Baseline pMDD/pGAD was reported by 44.5%, 39.8%, 45.4%, and 39.1% of patients receiving tofacitinib 5 mg BID, tofacitinib 10 mg BID, adalimumab, and placebo, respectively. SF-36 MCS improvements were greater for tofacitinib versus adalimumab/placebo through month 6, with numerical improvements for tofacitinib versus adalimumab sustained through month 12, when the proportions of patients with baseline pMDD/pGAD who continued to have pMDD/pGAD were reduced. RA efficacy outcomes were generally similar in patients with/without baseline pMDD/pGAD | ||
| 520 | |a CONCLUSIONS: The percentage of patients with pMDD/pGAD reduced from baseline over 1 year of treatment with tofacitinib or adalimumab. Effective treatment of underlying RA may lead to improvements in depression and anxiety, based on the SF-36 MCS. Specially designed studies using gold-standard diagnostic tools would be warranted to investigate this further. Video Abstract available for this article | ||
| 520 | |a TRIAL REGISTRATION: NCT00960440, NCT00847613, NCT00814307, NCT00856544, NCT00853385, NCT02187055. Video Abstract (MP4 204475 KB) | ||
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a JAK inhibitor | |
| 650 | 4 | |a Rheumatoid arthritis | |
| 650 | 4 | |a Tofacitinib | |
| 700 | 1 | |a Jain, Rakesh |e verfasserin |4 aut | |
| 700 | 1 | |a Irazoque, Fedra |e verfasserin |4 aut | |
| 700 | 1 | |a Madariaga, Hugo |e verfasserin |4 aut | |
| 700 | 1 | |a Gruben, David |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Lisy |e verfasserin |4 aut | |
| 700 | 1 | |a Stockert, Lori |e verfasserin |4 aut | |
| 700 | 1 | |a Santana, Karina |e verfasserin |4 aut | |
| 700 | 1 | |a Ebrahim, Abbas |e verfasserin |4 aut | |
| 700 | 1 | |a Ponce de Leon, Dario |e verfasserin |4 aut | |
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