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Background <p>Patients with rheumatoid arthritis (RA) who have an inadequate response or intolerance to methotrexate require effective and safe alternative therapies. Baricitinib, a Janus kinase inhibitor, has shown efficacy in RA, but dose-dependent outcomes in developing countries remain limited.</p> Objectives <p>To compare the efficacy and safety of baricitinib 2&#xa0;mg versus 4&#xa0;mg, both in combination with methotrexate, in patients with moderate-to-severe RA with an inadequate response to methotrexate.</p> Methods <p>This was a 24-week, open-label, randomized controlled trial conducted in a developing country. Adult patients with moderate-to-severe RA and inadequate response or intolerance to methotrexate were randomly assigned (1:1) to receive either baricitinib 2&#xa0;mg daily plus methotrexate 10&#xa0;mg weekly or baricitinib 4&#xa0;mg daily plus methotrexate 10&#xa0;mg weekly. Primary outcome: proportion of patients achieving low disease activity (LDA) according to DAS28-CRP at week 24. Secondary endpoints included LDA by DAS28-ESR and Clinical Disease Activity Index (CDAI). The Simplified Disease Activity Index (SDAI), functional improvement assessed by the Bangla Health Assessment Questionnaire–Disability Index (B-HAQ), and changes in core set outcomes and acute-phase reactants. Safety outcomes were assessed throughout the study. Analyses were conducted on an intention-to-treat basis.</p> Results <p>A total of 94 patients were randomized, with 47 per treatment group. At week 24, LDA by DAS28-CRP was achieved by 38 patients (84.4%) in the baricitinib 4&#xa0;mg group compared with 18 patients (45.0%) in the baricitinib 2&#xa0;mg group (<i>P</i> = 0.01). Remission alone occurred in 16 patients (35.6%) receiving 4&#xa0;mg and six patients (15.0%) receiving 2&#xa0;mg (<i>P</i> = 0.03). LDA rates were also significantly higher in the 4&#xa0;mg group, as assessed by CDAI (82.2% vs. 50.0%; <i>P</i> = 0.01) and SDAI (80.0% vs. 47.5%; <i>P</i> = 0.02). Except for erythrocyte sedimentation rate, all core set outcomes improved significantly more in the 4&#xa0;mg group (<i>P</i> &lt; 0.05). Functional status improved significantly within both groups (<i>P</i> &lt; 0.05). Adverse events were generally mild to moderate. Herpes zoster occurred in two patients (4.5%) in the 4&#xa0;mg group and one patient (2.5%) in the 2&#xa0;mg group. No cases of tuberculosis, malignancy, venous thromboembolism, or death were observed.</p> Conclusions <p>In patients with moderate-to-severe RA and an inadequate response to methotrexate, 4&#xa0;mg baricitinib demonstrated superior efficacy compared with 2&#xa0;mg baricitinib, with a comparable safety profile over 24 weeks.</p> Trial registration <p>This study was registered with ClinicalTrials.gov (Identifier: NCT05660655, <a href="https://clinicaltrials.gov/ct2/show/NCT05660655">https://clinicaltrials.gov/ct2/show/NCT05660655</a>) on 13 December 2022.</p>

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Baricitinib in moderate to severe rheumatoid arthritis: dose-dependent efficacy and safety in a randomized clinical trial in a developing country

  • 期刊论文

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  • 发表日期：

    2026年3月30日

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  • Md. Sadikul Islam,
  • Minhaj Rahim Choudhury,
  • Mohammad Abul Kalam Azad,
  • Md. Abu Shahin,
  • Syed Atiqul Haq,
  • S. M. Zobair Hossain,
  • Nabil Amin Khan,
  • Md. Atiqur Rahman

摘要

Background

Patients with rheumatoid arthritis (RA) who have an inadequate response or intolerance to methotrexate require effective and safe alternative therapies. Baricitinib, a Janus kinase inhibitor, has shown efficacy in RA, but dose-dependent outcomes in developing countries remain limited.

Objectives

To compare the efficacy and safety of baricitinib 2 mg versus 4 mg, both in combination with methotrexate, in patients with moderate-to-severe RA with an inadequate response to methotrexate.

Methods

This was a 24-week, open-label, randomized controlled trial conducted in a developing country. Adult patients with moderate-to-severe RA and inadequate response or intolerance to methotrexate were randomly assigned (1:1) to receive either baricitinib 2 mg daily plus methotrexate 10 mg weekly or baricitinib 4 mg daily plus methotrexate 10 mg weekly. Primary outcome: proportion of patients achieving low disease activity (LDA) according to DAS28-CRP at week 24. Secondary endpoints included LDA by DAS28-ESR and Clinical Disease Activity Index (CDAI). The Simplified Disease Activity Index (SDAI), functional improvement assessed by the Bangla Health Assessment Questionnaire–Disability Index (B-HAQ), and changes in core set outcomes and acute-phase reactants. Safety outcomes were assessed throughout the study. Analyses were conducted on an intention-to-treat basis.

Results

A total of 94 patients were randomized, with 47 per treatment group. At week 24, LDA by DAS28-CRP was achieved by 38 patients (84.4%) in the baricitinib 4 mg group compared with 18 patients (45.0%) in the baricitinib 2 mg group (P = 0.01). Remission alone occurred in 16 patients (35.6%) receiving 4 mg and six patients (15.0%) receiving 2 mg (P = 0.03). LDA rates were also significantly higher in the 4 mg group, as assessed by CDAI (82.2% vs. 50.0%; P = 0.01) and SDAI (80.0% vs. 47.5%; P = 0.02). Except for erythrocyte sedimentation rate, all core set outcomes improved significantly more in the 4 mg group (P < 0.05). Functional status improved significantly within both groups (P < 0.05). Adverse events were generally mild to moderate. Herpes zoster occurred in two patients (4.5%) in the 4 mg group and one patient (2.5%) in the 2 mg group. No cases of tuberculosis, malignancy, venous thromboembolism, or death were observed.

Conclusions

In patients with moderate-to-severe RA and an inadequate response to methotrexate, 4 mg baricitinib demonstrated superior efficacy compared with 2 mg baricitinib, with a comparable safety profile over 24 weeks.

Trial registration

This study was registered with ClinicalTrials.gov (Identifier: NCT05660655, https://clinicaltrials.gov/ct2/show/NCT05660655) on 13 December 2022.