Efficacy of Ozoralizumab vs. Golimumab for Rheumatoid Arthritis: A Systematic Review
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Introduction: Rheumatoid arthritis, a systemic autoimmune disease, affects 13% of the world population. As a well-established therapy, golimumab provides a key benchmark for assessing novel biological treatments. In contrast, ozoralizumab represents an innovative therapeutic approach. This study aimed to comprehensively elucidate the efficacy of golimumab and ozoralizumab in reducing rheumatoid arthritis disease activity.
Methods: Literature searches were conducted throughout PubMed, Cochrane, and Web of Science using Boolean operators, covering available records from database inception until October 2024. The literature search was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The included studies were randomized controlled trials (RCT) evaluating the efficacy of ozoralizumab or golimumab for rheumatoid arthritis. Five studies from 2015 to 2022 were obtained and assessed using the Cochrane Risk of Bias 2 (ROB2) tool.
Results: The five studies consisted of two ozoralizumab trials and three golimumab trials conducted in Japan and the United States, involving 2,305 participants. All included studies exhibited a low risk of bias based on assessments undertaken using the ROB2 tool. The differences in Disease Activity Score-28 (DAS28) remission rates between ozoralizumab and placebo were 42.6% in one study and 6.3% in the other, whereas golimumab mainly showed smaller differences versus placebo across three studies (4.6%, 5.9%, and 10.4%).
Conclusion: This study demonstrates DAS28 remission in rheumatoid arthritis patients receiving either ozoralizumab or golimumab therapy. Nonetheless, further direct statistical studies are essential to determine which therapy is superior and under what circumstances it should be administered.
Highlights:
- This study provides robust evidence that establishes ozoralizumab as a novel tumor necrosis factor-alpha (TNF-α) inhibitor for rheumatoid arthritis.
- According to the findings, ozoralizumab may be a clinician's choice due to its comparable efficacy and potential advantages over golimumab.
Alivernini S, Tolusso B, Petricca L, Ferraccioli G, Gremese E (2019). Rheumatoid arthritis. In: Mosaic of Autoimmunity. Elsevier. doi: 10.1016/B978-0-12-814307-0.00046-3.
Chandler J, Clarke M, McKenzie J, Boutron I, Welch V (Eds.) (2016). Cochrane methods. Cochrane Database of Systematic Reviews 10(Supplement 1). doi: 10.1002/14651858.CD201601.
Emery P, Fleischmann RM, Strusberg I, Durez P, Nash P, et al. (2016). Efficacy and safety of subcutaneous golimumab in methotrexate-naive patients with rheumatoid arthritis: Five-year results of a randomized clinical trial. Arthritis Care & Research 68(6): 744–752. doi: 10.1002/acr.22759.
Erickson AR, Cannella AC, Mikuls TR (2017). Clinical features of rheumatoid arthritis. In: Kelley and Firestein’s Textbook of Rheumatology. Elsevier. doi: 10.1016/B978-0-323-31696-5.00070-X.
Furst DE, Jaworski J, Wojciechowski R, Wiland P, Dudek A, et al. (2022). Efficacy and safety of switching from reference adalimumab to CT-P17 (100 mg/ml): 52-week randomized, double-blind study in rheumatoid arthritis. Rheumatology 61(4): 1385–1395. doi: 10.1093/rheumatology/keab460.
Harzallah I, Rigaill J, Williet N, Paul S, Roblin X (2017). Golimumab pharmacokinetics in ulcerative colitis: A literature review. Therapeutic Advances in Gastroenterology 10(1): 89–100. doi: 10.1177/1756283X16676194.
Hidayat R, Suryana BPP, Wijaya LK, Ariane A, Hellmi RY, et al. (Eds.) (2021). Diagnosis dan pengelolaan artritis reumatoid, rekomendasi Perhimpunan Reumatologi Indonesia 2021. Jakarta: Indonesian Rheumatology Association. Retrieved from https://reumatologi.or.id/rekomendasi-ra-diagnosis-dan-pengelolaan-artritis-reumatoid/.
Ishiwatari-Ogata C, Kyuuma M, Ogata H, Yamakawa M, Iwata K, et al. (2022). Ozoralizumab, a humanized anti-TNFα NANOBODY® compound, exhibits efficacy not only at the onset of arthritis in a human TNF transgenic mouse but also during secondary failure of administration of an anti-TNFα IgG. Frontiers in Immunology 13. doi: 10.3389/fimmu.2022.853008.
Kerschbaumer A, Sepriano A, Smolen JS, van der Heijde D, Dougados M, et al. (2020). Efficacy of pharmacological treatment in rheumatoid arthritis: A systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritis. Annals of the Rheumatic Diseases 79(6): 744–759. doi: 10.1136/annrheumdis-2019-216656.
Keystone EC, Genovese MC, Hall S, Bae SC, Han C, et al. (2016). Safety and efficacy of subcutaneous golimumab in patients with active rheumatoid arthritis despite methotrexate therapy: Final 5-year results of the GO-FORWARD Trial. The Journal of Rheumatology 43(2): 298–306. doi: 10.3899/jrheum.150712.
Kronzer VL, Bridges SL, Davis JM (2021). Why women have more autoimmune diseases than men: An evolutionary perspective. Evolutionary Applications 14(3): 629–633. doi: 10.1111/eva.13167.
Lahita RG (2023). Sex and gender influence on immunity and autoimmunity. Frontiers in Immunology 14. doi: 10.3389/fimmu.2023.1142723.
Luttropp K, Dozier M, Justo N, Cornillie F, Kachroo S, et al. (2019). Real-world treatment persistence of golimumab in the management of immune-mediated rheumatic diseases in Europe: A systematic literature review. BMJ Open 9(5): e027456. doi: 10.1136/bmjopen-2018-027456.
Microsoft Inc. (2025). Microsoft Excel for Windows, version 2505. Redmond, WA: Microsoft Inc. Retrieved from https://learn.microsoft.com/en-us/officeupdates/current-channel.
Ministry of Health of the Republic of Indonesia (2019). Laporan nasional Riskesdas 2018. Jakarta: Badan Penelitian dan Pengembangan Kesehatan. Retrieved from https://repository.badankebijakan.kemkes.go.id/id/eprint/3514/1/Laporan Riskesdas 2018 Nasional.pdf.
Nasir N, Majid H, Khan A, Awan S, Riaz M (2022). Disease activity correlates and functionality in patients with rheumatoid arthritis – Real-world experience from a South Asian country. Rheumatology 60(3): 183–191. doi: 10.5114/reum.2022.117838.
Oyama S, Ebina K, Etani Y, Hirao M, Kyuuma M, et al. (2022). A novel anti-TNF-α drug ozoralizumab rapidly distributes to inflamed joint tissues in a mouse model of collagen induced arthritis. Scientific Reports 12(1): 18102. doi: 10.1038/s41598-022-23152-6.
Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, et al. (2021). The PRISMA 2020 statement: An updated guideline for reporting systematic reviews. BMJ 372: n71. doi: 10.1136/bmj.n71.
Patidar V, Shah S, Kumar R, Singh PK, Singh SB, et al. (2022). A molecular insight of inflammatory cascades in rheumatoid arthritis and anti-arthritic potential of phytoconstituents. Molecular Biology Reports 49(3): 2375–2391. doi: 10.1007/s11033-021-06986-7.
Pelechas E, Voulgari PV, Drosos AA (2019). Golimumab for rheumatoid arthritis. Journal of Clinical Medicine 8(3): 387. doi: 10.3390/jcm8030387.
Pisaniello HL, Whittle SL, Lester S, Menz F, Metcalf R, et al. (2022). Using the derived 28-joint disease activity score patient-reported components (DAS28-P) index as a discriminatory measure of response to disease-modifying anti-rheumatic drug therapy in early rheumatoid arthritis. BMC Rheumatology 6(1): 67. doi: 10.1186/s41927-022-00299-3.
Purwaningsari D, Nugraha J, Wahyuningsih SPA, Hayaza S, Susilo RJK, et al. (2020). Effect of polysaccharide krestin on MMP3 expression and foot diameter in rheumatoid arthritis in rat. Indian Veterinary Journal 97(1): 24–26. Retrieved from https://ivj.org.in/journal-article-viewer/799e87bf-5dfc-4921-a977-f4b86423dd10/.
Savitri SA, Kartidjo P, Rahmadi AR, Vikasari SN (2019). Hubungan pemilihan obat dan keberhasilan terapi pasien rheumatoid arthritis. Indonesian Journal of Clinical Pharmacy 8(4): 237–245. doi: 10.15416/ijcp.2019.8.4.237.
Shimizu H, Kobayashi H, Kanbori M, Ishii Y (2021). Effectiveness of golimumab in rheumatoid arthritis patients with inadequate response to first-line biologic therapy: Results from a Japanese post-marketing surveillance study. Modern Rheumatology 31(3): 556–565. doi: 10.1080/14397595.2020.1797266.
Takeuchi T (2023). Structural, nonclinical, and clinical features of ozoralizumab: A novel tumour necrosis factor inhibitor. Modern Rheumatology 33(6): 1059–1067. doi: 10.1093/mr/road038.
Takeuchi T, Kawanishi M, Nakanishi M, Yamasaki H, Tanaka Y (2022). Phase II/III results of a trial of anti–tumor necrosis factor multivalent NANOBODY compound ozoralizumab in patients with rheumatoid arthritis. Arthritis & Rheumatology 74(11): 1776–1785. doi: 10.1002/art.42273.
Tanaka Y, Harigai M, Takeuchi T, Yamanaka H, Ishiguro N, et al. (2016). Clinical efficacy, radiographic progression, and safety through 156 weeks of therapy with subcutaneous golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis despite prior methotrexate therapy: Final results of the randomized GO-FORTH trial. Modern Rheumatology 26(4): 481–490. doi: 10.3109/14397595.2015.1109762.
Tanaka Y, Kawanishi M, Nakanishi M, Yamasaki H, Takeuchi T (2023). Efficacy and safety of the anti-TNF multivalent NANOBODY® compound ozoralizumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: A 52-week result of a phase II/III study (OHZORA trial). Modern Rheumatology 33(5): 883–890. doi: 10.1093/mr/roac119.
Tipsing W, Sawanyawisuth K (2021). Predictive clinical factors in rheumatoid arthritis using disease activity and functional score. Rheumatology 59(5): 309–312. doi: 10.5114/reum.2021.110611.
Volkov M, van Schie KA, van der Woude D (2020). Autoantibodies and B cells: The ABC of rheumatoid arthritis pathophysiology. Immunological Reviews 294(1): 148–163. doi: 10.1111/imr.12829.
World Health Organization (2022). Musculoskeletal health. Retrieved from https://www.who.int/news-room/fact-sheets/detail/musculoskeletal-conditions.
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