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A Matching-Adjusted Indirect Comparison of Upadacitinib Versus Tofacitinib in Adults with Moderate-to-Severe Rheumatoid Arthritis.
Rheumatol Ther. 2020 Nov 26 [Online ahead of print]RT

Abstract

INTRODUCTION

Upadacitinib and tofacitinib are Janus kinase inhibitors approved for moderate-to-severe rheumatoid arthritis (RA). In the absence of head-to-head trials comparing their effectiveness, this study assessed the efficacy of upadacitinib 15 mg once-daily monotherapy/combination therapy against tofacitinib 5 mg twice-daily combination therapy among patients with RA using matching-adjusted indirect comparisons (MAICs).

METHODS

The first of two MAICs used individual patient data (IPD) from the 14-week SELECT-MONOTHERAPY trial (upadacitinib [n = 217] vs. methotrexate [n = 216]) and published data from the ORAL Standard trial (tofacitinib + methotrexate [n = 204] vs. methotrexate [n = 108]). The second MAIC used IPD from the 26-week SELECT-COMPARE trial (upadacitinib + methotrexate [n = 647] vs. adalimumab + methotrexate [n = 324]) and published data from ORAL Strategy (tofacitinib + methotrexate [n = 376] vs. adalimumab + methotrexate [n = 386]). Data from patients in the upadacitinib trials were re-weighted based on age, sex, race, swollen joint count 66/28, tender joint count 68/28, C-reactive protein (CRP), and patients' global assessments to match the patient characteristics in tofacitinib trials. After matching, ACR20/50/70 and clinical remission (SDAI[CRP] ≤ 3.3, CDAI ≤ 2.8, DAS28-ESR/CRP < 2.6) were compared for upadacitinib vs. tofacitinib + methotrexate at month 3 and upadacitinib + methotrexate vs. tofacitinib + methotrexate at months 3 and 6 using Wald tests.

RESULTS

At month 3, upadacitinib monotherapy patients experienced significantly larger improvement in ACR70 compared to tofacitinib + methotrexate (mean difference in difference [DID]: 9.9%; p = 0.019), while upadacitinib + methotrexate was associated with higher ACR50 compared to tofacitinib + methotrexate (DID: 12.9%; p = 0.011). At month 6, upadacitinib + methotrexate patients experienced significantly larger improvement in SDAI/CDAI/DAS28-ESR clinical remission compared to tofacitinib + methotrexate, with DIDs of 9.1% (p = 0.011), 7.5% (p = 0.038), and 11.3% (p = 0.002), respectively.

CONCLUSIONS

Compared to tofacitinib combination therapy, treatment with upadacitinib monotherapy and combination therapy were associated with improved outcomes at 3/6 months (monotherapy: ACR70; combination: ACR50, SDAI, CDAI, and DAS28-ESR remission).

Authors+Show Affiliations

NIHR Clinical Research Facility, University Hospital Southampton NHS Foundation Trust, Southampton, UK.AbbVie, Inc., North Chicago, IL, USA.AbbVie, Inc., North Chicago, IL, USA.Analysis Group, Inc., Los Angeles, CA, USA.AbbVie, Inc., North Chicago, IL, USA.Analysis Group, Inc., Los Angeles, CA, USA. keith.betts@analysisgroup.com.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

33244703

Citation

Edwards, Christopher J., et al. "A Matching-Adjusted Indirect Comparison of Upadacitinib Versus Tofacitinib in Adults With Moderate-to-Severe Rheumatoid Arthritis." Rheumatology and Therapy, 2020.
Edwards CJ, Sawant R, Garg V, et al. A Matching-Adjusted Indirect Comparison of Upadacitinib Versus Tofacitinib in Adults with Moderate-to-Severe Rheumatoid Arthritis. Rheumatol Ther. 2020.
Edwards, C. J., Sawant, R., Garg, V., Du, E. X., Friedman, A., & Betts, K. A. (2020). A Matching-Adjusted Indirect Comparison of Upadacitinib Versus Tofacitinib in Adults with Moderate-to-Severe Rheumatoid Arthritis. Rheumatology and Therapy. https://doi.org/10.1007/s40744-020-00257-w
Edwards CJ, et al. A Matching-Adjusted Indirect Comparison of Upadacitinib Versus Tofacitinib in Adults With Moderate-to-Severe Rheumatoid Arthritis. Rheumatol Ther. 2020 Nov 26; PubMed PMID: 33244703.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A Matching-Adjusted Indirect Comparison of Upadacitinib Versus Tofacitinib in Adults with Moderate-to-Severe Rheumatoid Arthritis. AU - Edwards,Christopher J, AU - Sawant,Ruta, AU - Garg,Vishvas, AU - Du,Ella X, AU - Friedman,Alan, AU - Betts,Keith A, Y1 - 2020/11/26/ PY - 2020/10/05/received PY - 2020/11/10/accepted PY - 2020/11/27/entrez PY - 2020/11/28/pubmed PY - 2020/11/28/medline KW - Combination therapy KW - Efficacy KW - Matching-adjusted indirect comparison KW - Monotherapy KW - Rheumatoid arthritis KW - Tofacitinib KW - Upadacitinib JF - Rheumatology and therapy JO - Rheumatol Ther N2 - INTRODUCTION: Upadacitinib and tofacitinib are Janus kinase inhibitors approved for moderate-to-severe rheumatoid arthritis (RA). In the absence of head-to-head trials comparing their effectiveness, this study assessed the efficacy of upadacitinib 15 mg once-daily monotherapy/combination therapy against tofacitinib 5 mg twice-daily combination therapy among patients with RA using matching-adjusted indirect comparisons (MAICs). METHODS: The first of two MAICs used individual patient data (IPD) from the 14-week SELECT-MONOTHERAPY trial (upadacitinib [n = 217] vs. methotrexate [n = 216]) and published data from the ORAL Standard trial (tofacitinib + methotrexate [n = 204] vs. methotrexate [n = 108]). The second MAIC used IPD from the 26-week SELECT-COMPARE trial (upadacitinib + methotrexate [n = 647] vs. adalimumab + methotrexate [n = 324]) and published data from ORAL Strategy (tofacitinib + methotrexate [n = 376] vs. adalimumab + methotrexate [n = 386]). Data from patients in the upadacitinib trials were re-weighted based on age, sex, race, swollen joint count 66/28, tender joint count 68/28, C-reactive protein (CRP), and patients' global assessments to match the patient characteristics in tofacitinib trials. After matching, ACR20/50/70 and clinical remission (SDAI[CRP] ≤ 3.3, CDAI ≤ 2.8, DAS28-ESR/CRP < 2.6) were compared for upadacitinib vs. tofacitinib + methotrexate at month 3 and upadacitinib + methotrexate vs. tofacitinib + methotrexate at months 3 and 6 using Wald tests. RESULTS: At month 3, upadacitinib monotherapy patients experienced significantly larger improvement in ACR70 compared to tofacitinib + methotrexate (mean difference in difference [DID]: 9.9%; p = 0.019), while upadacitinib + methotrexate was associated with higher ACR50 compared to tofacitinib + methotrexate (DID: 12.9%; p = 0.011). At month 6, upadacitinib + methotrexate patients experienced significantly larger improvement in SDAI/CDAI/DAS28-ESR clinical remission compared to tofacitinib + methotrexate, with DIDs of 9.1% (p = 0.011), 7.5% (p = 0.038), and 11.3% (p = 0.002), respectively. CONCLUSIONS: Compared to tofacitinib combination therapy, treatment with upadacitinib monotherapy and combination therapy were associated with improved outcomes at 3/6 months (monotherapy: ACR70; combination: ACR50, SDAI, CDAI, and DAS28-ESR remission). SN - 2198-6576 UR - https://www.unboundmedicine.com/medline/citation/33244703/A_Matching_Adjusted_Indirect_Comparison_of_Upadacitinib_Versus_Tofacitinib_in_Adults_with_Moderate_to_Severe_Rheumatoid_Arthritis_ L2 - https://link.springer.com/article/10.1007/s40744-020-00257-w DB - PRIME DP - Unbound Medicine ER -
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