Comparative Efficacy of Methotrexate and Baricitinib as First-Line Therapy in Seropositive Rheumatoid Arthritis; A Clinical Study
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Abstract
Background: Rheumatoid arthritis (RA) is a chronic inflammatory disease that severely impacts joint function and quality of life. Methotrexate (MTX) has been the traditional first-line therapy; however, the advent of targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs) like Baricitinib offers an alternative with potential benefits in efficacy and safety. Objective: This study aims to compare the efficacy and safety of Methotrexate and Baricitinib as first-line therapies in seropositive RA patients. Methods: A randomized, controlled trial was conducted at Rajshahi Medical College Hospital and metacenters in Rajshahi district from January 2022 to December 2023. A total of 200 patients were included, with 100 receiving Methotrexate and 100 receiving Baricitinib. Disease activity scores (DAS28), radiographic progression, and patient-reported outcomes were measured at baseline, 12 weeks, and 24 weeks. Safety profiles were evaluated through the incidence of adverse events. Results: At 24 weeks, 62% of the Baricitinib group achieved clinical remission (DAS28 < 2.6) compared to 48% in the Methotrexate group (p = 0.03). Baricitinib showed a faster onset of action, with 38% achieving remission by 12 weeks, compared to 25% in the Methotrexate group (p = 0.02). Radiographic progression was significantly lower in the Baricitinib group (12%) compared to the Methotrexate group (21%) (p = 0.04). Additionally, a higher proportion of patients in the Baricitinib group reported significant improvement in physical function (76%) compared to the Methotrexate group (60%) (p = 0.01). Adverse events were observed in 18% of Baricitinib-treated patients and 26% of Methotrexate-treated patients (p = 0.05). Conclusions: Baricitinib demonstrated superior efficacy, with faster clinical remission and reduced radiographic progression, along with a more favorable safety profile compared to Methotrexate as a first-line therapy in seropositive RA patients.
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1. Gilbert, B. T. P., Mongin, D., Aymon, R., Lauper, K., Laedermann, C., Perrier, C., ... & Finckh, A. (2024). Comparative effectiveness of baricitinib and alternative biological DMARDs in a Swiss cohort study of patients with RA. BMJ open, 14(3), e072300.
2. Cheng, Q., Chen, X., Wu, H., & Du, Y. (2021). AB0042 THREE HEMATOLOGIC/IMMUNE SYSTEM-SPECIFIC EXPRESSED GENES ARE CONSIDERED AS THE POTENTIAL BIOMARKERS FOR THE DIAGNOSIS OF EARLY RHEUMATOID ARTHRITIS THROUGH BIOINFORMATICS ANALYSIS.
3. Valerio, V., Kwok, M., Loewen, H., Winkler, J., Mody, G. M., Scuccimarri, R., ... & Colmegna, I. (2021). Systematic review of recommendations on the use of methotrexate in rheumatoid arthritis. Clinical Rheumatology, 40, 1259-1271.
4. Cherif, R. A., Yargui, L., Slimani, S., Aissoug, A., Rahmani, S., Bouaicha, M. N., & Boukrous, H. (2022). Impact of chronic low dose methotrexate treatment in rheumatoid arthritis on biochemical parameters in a population of eastern Algeria: A cross-sectional study. Algerian Journal of Health Sciences, 4(1), 39-44.
5. Mogul, A., Corsi, K., & McAuliffe, L. (2019). Baricitinib: the second FDA-approved JAK inhibitor for the treatment of rheumatoid arthritis. Annals of Pharmacotherapy, 53(9), 947-953.
6. Chovatiya, R., & Paller, A. S. (2021). JAK inhibitors in the treatment of atopic dermatitis. Journal of Allergy and Clinical Immunology, 148(4), 927-940.
7. Takahashi, N., Asai, S., Kobayakawa, T., Kaneko, A., Watanabe, T., Kato, T., ... & Kojima, T. (2020). Predictors for clinical effectiveness of baricitinib in rheumatoid arthritis patients in routine clinical practice: data from a Japanese multicenter registry. Scientific Reports, 10(1), 21907.
8. van Delft, M. A., & Huizinga, T. W. (2020). An overview of autoantibodies in rheumatoid arthritis. Journal of autoimmunity, 110, 102392.
9. Mohan, A. (2021). Evaluation of methotrexate polyglutamates as a biomarker for optimizing methotrexate treatment in Crohn’s disease (Doctoral dissertation).
10. Wang, F., Sun, L., Wang, S., Davis III, J. M., Matteson, E. L., Murad, M. H., ... & Vassallo, R. (2020, July). Efficacy and safety of tofacitinib, baricitinib, and upadacitinib for rheumatoid arthritis: a systematic review and meta-analysis. In Mayo Clinic Proceedings (Vol. 95, No. 7, pp. 1404-1419). Elsevier.
11. Gao, Y., Gao, Y. N., Wang, M. J., Zhang, Y., Zhang, F. Q., He, Z. X., ... & Wen, C. P. (2023). Efficacy and safety of tofacitinib combined with methotrexate in the treatment of rheumatoid arthritis: A systematic review and meta-analysis. Heliyon, 9(5).
12. Fleischmann, R., Takeuchi, T., Schiff, M., Schlichting, D., Xie, L., Issa, M., ... & Zerbini, C. A. (2020). Efficacy and safety of Long‐Term Baricitinib with and without methotrexate for the treatment of rheumatoid arthritis: experience with Baricitinib monotherapy continuation or after switching from methotrexate monotherapy or Baricitinib plus methotrexate. Arthritis Care & Research, 72(8), 1112-1121.
13. Biswas, B., Chowdhury, A. S., Akter, S., Fatema, K., Reem, C. S. A., Tuhin, E., & Hasan, H. (2024). Knowledge and attitude about COVID-19 and importance of diet: A cross-sectional study among Bangladeshi people. Bangladesh Journal of Food and Nutrition, 1(1), 04-12.
14. Emery, P., Durez, P., Hueber, A. J., de la Torre, I., Larsson, E., Holzkämper, T., & Tanaka, Y. (2021). Baricitinib inhibits structural joint damage progression in patients with rheumatoid arthritis—a comprehensive review. Arthritis research & therapy, 23, 1-13.
15. McInnes, I. B., Szekanecz, Z., McGonagle, D., Maksymowych, W. P., Pfeil, A., Lippe, R., ... & Deodhar, A. (2022). A review of JAK–STAT signalling in the pathogenesis of spondyloarthritis and the role of JAK inhibition. Rheumatology, 61(5), 1783-1794.
16. Kubo, S., Nakayamada, S., & Tanaka, Y. (2019). Baricitinib for the treatment of rheumatoid arthritis and systemic lupus erythematosus: a 2019 update. Expert review of clinical immunology, 15(7), 693-700.
17. Fleischmann, R. (2021). Biologic disease-modifying anti-rheumatic drugs and kinase inhibitors: differences in efficacy and safety in rheumatoid arthritis. Clinical Rheumatology, 40(11), 4369-4372.
18. Almutairi, K., Nossent, J., Preen, D., Keen, H., & Inderjeeth, C. (2021). The global prevalence of rheumatoid arthritis: a meta-analysis based on a systematic review. Rheumatology international, 41(5), 863-877.
19. Iqbal, S., & Rattu, M. A. (2019). Review of rheumatoid arthritis. US Pharm, 44(1), 8-11.
20. Begum, M. M. M., Gupta, R., Sunny, B., & Lutfor, Z. L. (2024). Advancements in Early Detection and Targeted Therapies for Breast Cancer; A Comprehensive Analysis. Asia Pacific Journal of Cancer Research, 1(1), 4-13.
21. Ll Wilkinson, M. G., Deakin, C. T., Papadopoulou, C., Eleftheriou, D., & Wedderburn, L. R. (2021). JAK inhibitors: a potential treatment for JDM in the context of the role of interferon-driven pathology. Pediatric Rheumatology, 19, 1-12.