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Clinical Trial
. 2022 Mar;8(1):e001994.
doi: 10.1136/rmdopen-2021-001994.

Achieving pain control in early rheumatoid arthritis with baricitinib monotherapy or in combination with methotrexate versus methotrexate monotherapy

Peter C Taylor  1 , Rieke Alten  2 , Jose María Álvaro Gracia  3 , Yuko Kaneko  4 , Chad Walls  5 , Amanda Quebe  5 , Bochao Jia  5 , Natalia Bello  5 , Jorge Ross Terres  5 , Roy Fleischmann  6
Affiliations
Clinical Trial

Achieving pain control in early rheumatoid arthritis with baricitinib monotherapy or in combination with methotrexate versus methotrexate monotherapy

Peter C Taylor et al. RMD Open. 2022 Mar.

Abstract

Objectives: This post hoc analysis assessed speed, magnitude and maintenance of pain improvement in patients with early rheumatoid arthritis (RA) receiving baricitinib, baricitinib and methotrexate (MTX), or MTX over 1 year. Cumulative pain and quality of life benefits were also assessed.

Methods: Randomised, double-blind, phase 3 study RA-BEGIN (NCT01711359) compared baricitinib 4 mg (N=159), baricitinib 4 mg +MTX (N=215) and MTX (N=210) in patients with RA who had no or limited prior disease-modifying antirheumatic drug treatment. Pain was assessed on a 0-100 mm Visual Analogue Scale (VAS). Proportion of patients with ≥30%, ≥50% and ≥70% pain improvement from baseline; ≤20 mm and ≤10 mm on the pain VAS; and time to achieve pain improvement thresholds were assessed over 52 weeks, as were Patient Global Assessment (PtGA) and 36-Item Short Form Health Survey Physical Component Score (SF-36 PCS) outcomes.

Results: Baricitinib monotherapy or combination with MTX provides greater (least square mean changes (LSM) from baseline -40 mm and -43 mm, respectively) and more rapid (median 12 and 8 weeks to ≥70% improvement, respectively) pain relief than MTX alone (LSM -31 mm, median 20 weeks to ≥70% improvement) over 52 weeks. Baricitinib, alone or combination, provides 9-10 additional weeks of limited to no pain, similar gain in achievable wellness measured through PtGA, and 5-7 additional weeks with change in SF-36 PCS ≥5 vs MTX over 1 year.

Conclusions: Patients treated with baricitinib reported significantly greater and more rapid pain relief, more weeks with limited to no pain, and clinically meaningful improvements in physical health than patients treated with MTX alone over 1 year.

Keywords: arthritis, rheumatoid; patient reported outcome measures; therapeutics.

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Conflict of interest statement

Competing interests: PCT has received research grants and/or consultation fees from Galapagos, Gilead, Eli Lilly and Company, AbbVie, and Pfizer. Rieke Alten has received honoraria and research grants from Abbvie, BMS, Galalapagos, Gilead, Janssen, Lilly, MSD, Novartis and Pfizer. JMAG has received consulting fees from Eli Lilly and Company and Pfizer; honoraria from Abbvie, Eli Lilly and Company, Galapagos, Gilead, Pfizer, Roche and UCB; and support for attending meetings from Abbvie, MSD, Pfizer, Roche and UCB. YK has received grants or speaking fees from AbbVie, Astellas, Ayumi, Bristol–Myers Squibb, Chugai, Eisai, Eli Lilly and Company, Jansen, Kissei, Kirin, Novartis pharma, Pfizer, Sanofi, Takeda, Tanabe-Mitsubishi and UCB. CW, AQ, BJ, NB and JRT are employees and may be shareholders of Eli Lilly and Company. RF has received grants from AbbVie, Eli Lilly and Company, Gilead, and Pfizer; consulting fees from AbbVie, Eli Lilly and Company, Gilead, and Pfizer; and participated on a Data Safety Monitoring Board or Advisory Board for AbbVie, Eli Lilly and Company, Gilead and Pfizer.

Figures

Figure 1
Figure 1
Least squares mean change from baseline in pain VAS over time. ***p<0.001 vs MTX. BARI, baricitinib; LSM, least squares mean; MTX, methotrexate; VAS, Visual Analogue Scale.
Figure 2
Figure 2
(A) Proportion of patients who achieved thresholds of ≥30%, ≥50% and ≥70% improvement in pain VAS at week 24. (B–D) Time to event analysis depicting the cumulative proportion of patients who achieved ≥30%, ≥50% and ≥70% improvement in pain VAS scores, respectively, over 52 weeks. (E) Median time for patients to achieve ≥30%, ≥50% and ≥70% improvement in pain VAS. *P<0.05, **p<0.01, ***p<0.001 vs MTX. BARI, baricitinib; MTX, methotrexate; VAS, Visual Analogue Scale.
Figure 3
Figure 3
Percentage of patients meeting thresholds of remaining pain (VAS) at week 24 and week 52 by treatment group. **p<0.01, ***p<0.001 vs MTX. BARI, baricitinib; MTX, methotrexate; VAS, Visual Analogue Scale.
Figure 4
Figure 4
(A) The proportion (%) of patients with ≤10 mm pain, and (B) average number of weeks with pain Visual Analogue Scale (VAS) ≤10 mm per treatment group over 52 weeks calculated by area under the curve (AUC) analysis of the curve in (A). (C) The proportion (%) of patients with ≤20 mm pain and (D) average number of weeks with pain VAS ≤20 mm per treatment group over 52 weeks calculated by AUC analysis of the curve in (C). *P<0.05, **p<0.01, ***p<0.001 vs MTX. BARI, baricitinib; MTX, methotrexate.
Figure 5
Figure 5
(A) The proportion (%) of patients with ≤10 mm PtGA and (B) average number of weeks with PtGA ≤10 mm per treatment group over 52 weeks calculated by AUC analysis of the curve in (A). (C) The proportion (%) of patients with ≤20 mm PtGA and (D) average number of weeks with PtGA ≤20 mm per treatment group over 52 weeks calculated by AUC analysis of the curve in (C). *P<0.05, **p<0.01, ***p<0.001 vs MTX. AUC, area under the curve; BARI, baricitinib; MTX, methotrexate; PtGA, Patient Global Assessment.
Figure 6
Figure 6
(A) The proportion (%) of patients with ≥5 points SF-36 PCS improvement and (B) average number of weeks spent with ≥5 points improvement in SF-36 PCS per treatment group over 52 weeks calculated by AUC analysis of the curve in (A). *P<0.05, **p<0.01, ***p<0.001 vs MTX. AUC, area under the curve; BARI, baricitinib; CFB, change from baseline; MTX, methotrexate; PCS, Physical Component Score; SF-36, Short Form-36.
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