The effect of rituximab on systemic sclerosis: A systematic review and meta-analysis

https://doi.org/10.53730/ijhs.v6nS7.12801

Authors

  • Osama Saad Madhloom Al Mustansiriyah University College of Medicine Master from Baghdad University College of Medicine
  • Ali mohammed Al hamadani Al Mustansiriyah University College of Medicine Master from Baghdad University College of Medicine

Keywords:

Interstitial lung disease, Rituximab, Systemic sclerosis, Systematic review, cutaneous fibrosis

Abstract

Background: Skin fibrosis is a complication of the multifaceted and difficult condition known as systemic sclerosis (SSc). The interstitial lungs disease (ILD), which is a common consequence, has a worse prognosis. Although debates concerning its effectiveness and toxicity, cyclophosphamide is regarded as the gold standard for treating this condition. Furthermore, research employing the medication rituximab (RTX) has indicated that this treatment option could be beneficial. Objectives: The goal of this research was to evaluate the available scientific data on the impact of RTX on SSc. Methods: Clinical trials (CTs) investigating the application of RTX in SSc, published up to 2022, and were included in a systematic review (SR). Using methodical searching in academic databases employing a predetermined research methodology, the articles were located. SCIENCE DIRECT, SCOPUS, SCIELO, LILACS, PUBMED, , COCHRANE, WHOLIS, EMBASE, PAHO, and WEB OF SCIENCE were among the resources examined. A manually searching was done as well. Through using Jadad score, the Risk of Bias Tool (RoB 2.0), and the Risk of Bias in Non-Randomized Trials - of Treatments tools, the technical quality of the articles was assessed (ROBINS-I). Utilizing Review Manager, a meta-analysis of the randomized CTs had been carried out.

Downloads

Download data is not yet available.

References

Tang R, Yu J, Shi Y, Zou P, Zeng Z, Tang B, et al. Safety and efficacy of Rituximab in systemic sclerosis: a systematic review and meta-analysis. International immunopharmacology. 2020;83:106389.

Thiebaut M, Launay D, Rivière S, Mahévas T, Bellakhal S, Hachulla E, et al. Efficacy and safety of rituximab in systemic sclerosis: French retrospective study and literature review. Autoimmunity Reviews. 2018;17(6):582-7.

Daoussis D, Melissaropoulos K, Sakellaropoulos G, Antonopoulos I, Markatseli TE, Simopoulou T, et al., editors. A multicenter, open-label, comparative study of B-cell depletion therapy with Rituximab for systemic sclerosis-associated interstitial lung disease. Seminars in arthritis and rheumatism; 2017: Elsevier.

Elhai M, Boubaya M, Distler O, Smith V, Matucci-Cerinic M, Sancho JJA, et al. Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice: a prospective cohort study. Annals of the rheumatic diseases. 2019;78(7):979-87.

Ebata S, Yoshizaki A, Oba K, Kashiwabara K, Ueda K, Uemura Y, et al. Safety and efficacy of rituximab in systemic sclerosis (DESIRES): a double-blind, investigator-initiated, randomised, placebo-controlled trial. The Lancet Rheumatology. 2021;3(7):e489-e97.

de Figueiredo Caldas MMV, Neto FAB, de Azevedo KPM, Pimenta IDSF, De AKDSG, Piuvezam G. Rituximab in systemic sclerosis: A protocol for systematic review. Medicine. 2019;98(38).

Kowal-Bielecka O, Fransen J, Avouac J, Becker M, Kulak A, Allanore Y, et al. Update of EULAR recommendations for the treatment of systemic sclerosis. Annals of the rheumatic diseases. 2017;76(8):1327-39.

Goswami RP, Ray A, Chatterjee M, Mukherjee A, Sircar G, Ghosh P. Rituximab in the treatment of systemic sclerosis–related interstitial lung disease: a systematic review and meta-analysis. Rheumatology. 2021;60(2):557-67.

Boonstra M, Meijs J, Dorjée AL, Marsan NA, Schouffoer A, Ninaber MK, et al. Rituximab in early systemic sclerosis. RMD open. 2017;3(2):e000384.

Moradzadeh M, Aghaei M, Mehrbakhsh Z, Arab-Bafrani Z, Abdollahi N. Efficacy and safety of rituximab therapy in patients with systemic sclerosis disease (SSc): systematic review and meta-analysis. Clinical rheumatology. 2021;40(10):3897-918.

Misra DP, Ahmed S, Agarwal V. Is biological therapy in systemic sclerosis the answer? Rheumatology International. 2020;40(5):679-94.

Melsens K, Vandecasteele E, Deschepper E, Badot V, Blockmans D, Brusselle G, et al. Two years follow-up of an open-label pilot study of treatment with rituximab in patients with early diffuse cutaneous systemic sclerosis. Acta Clinica Belgica. 2018;73(2):119-25.

Hughes M, Denton CP, Khanna D. Rituximab for the treatment of systemic sclerosis-interstitial lung disease. Oxford University Press; 2021. p. 489-91.

Vilela VS, Maretti GB, Gama LMdS, Costa CHd, Rufino RL, Levy RA. Rituximab for the therapy of systemic sclerosis: a series of 10 cases in a single center. Revista Brasileira de Reumatologia. 2016;56:458-63.

Ebata S, Yoshizaki A, Oba K, Kashiwabara K, Ueda K, Uemura Y, et al. Safety and efficacy of rituximab in systemic sclerosis (DESIRES): open-label extension of a double-blind, investigators-initiated, randomised, placebo-controlled trial. The Lancet Rheumatology. 2022;4(8):e546-e55.

Cottin V, Brown KK. Interstitial lung disease associated with systemic sclerosis (SSc-ILD). Respiratory research. 2019;20(1):1-10.

Zamanian RT, Badesch D, Chung L, Domsic RT, Medsger T, Pinckney A, et al. Safety and efficacy of B-cell depletion with rituximab for the treatment of systemic sclerosis–associated pulmonary arterial hypertension: A multicenter, double-blind, randomized, placebo-controlled trial. American journal of respiratory and critical care medicine. 2021;204(2):209-21.

Sari A, Guven D, Armagan B, Erden A, Kalyoncu U, Karadag O, et al. Rituximab experience in patients with long-standing systemic sclerosis–associated interstitial lung disease: a series of 14 patients. JCR: Journal of Clinical Rheumatology. 2017;23(8):411-5.

Fraticelli P, Fischetti C, Salaffi F, Carotti M, Mattioli M, Pomponio G, et al. Combination therapy with rituximab and mycophenolate mofetil in systemic sclerosis. A single-centre case series study. Clin Exp Rheumatol. 2018;36(Suppl 113):142-5.

Moher D, Liberati A, Tetzlaff J, Altman DG, Group* P. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Annals of internal medicine. 2009;151(4):264-9.

Van Den Hoogen F, Khanna D, Fransen J, Johnson SR, Baron M, Tyndall A, et al. 2013 classification criteria for systemic sclerosis: an American College of Rheumatology/European League against Rheumatism collaborative initiative. Arthritis & Rheumatism. 2013;65(11):2737-47.

LeROY EC, Medsger Jr TA. Criteria for the classification of early systemic sclerosis. Journal of Rheumatology. 2001;28(7):1573-6.

Ouzzani M, Hammady H, Fedorowicz Z, Elmagarmid A. Rayyan—a web and mobile app for systematic reviews. Systematic reviews. 2016;5(1):1-10.

Halpern SH, Douglas MJ. Appendix: Jadad scale for reporting randomized controlled trials. Evidence-based Obstetric Anesthesia Oxford, UK: Blackwell Publishing Ltd. 2005:237-8.

Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. Bmj. 2011;343.

Sterne JA, Hernán MA, Reeves BC, Savović J, Berkman ND, Viswanathan M, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. bmj. 2016;355.

Daoussis D, Liossis S-NC, Tsamandas AC, Kalogeropoulou C, Kazantzi A, Sirinian C, et al. Experience with rituximab in scleroderma: results from a 1-year, proof-of-principle study. Rheumatology. 2010;49(2):271-80.

Sircar G, Goswami RP, Sircar D, Ghosh A, Ghosh P. Intravenous cyclophosphamide vs rituximab for the treatment of early diffuse scleroderma lung disease: open label, randomized, controlled trial. Rheumatology. 2018;57(12):2106-13.

Bosello S, De Santis M, Lama G, Spanò C, Angelucci C, Tolusso B, et al. B cell depletion in diffuse progressive systemic sclerosis: safety, skin score modification and IL-6 modulation in an up to thirty-six months follow-up open-label trial. Arthritis research & therapy. 2010;12(2):1-10.

Lafyatis R, Kissin E, York M, Farina G, Viger K, Fritzler MJ, et al. B cell depletion with rituximab in patients with diffuse cutaneous systemic sclerosis. Arthritis & Rheumatism: Official Journal of the American College of Rheumatology. 2009;60(2):578-83.

Smith V, Van Praet JT, Vandooren B, Van der Cruyssen B, Naeyaert J-M, Decuman S, et al. Rituximab in diffuse cutaneous systemic sclerosis: an open-label clinical and histopathological study. Annals of the rheumatic diseases. 2010;69(01):193-7.

Smith V, Piette Y, Van Praet JT, Decuman S, Deschepper E, Elewaut D, et al. Two-year results of an open pilot study of a 2-treatment course with rituximab in patients with early systemic sclerosis with diffuse skin involvement. The Journal of Rheumatology. 2013;40(1):52-7.

Bosello SL, De Luca G, Rucco M, Berardi G, Falcione M, Danza FM, et al., editors. Long-term efficacy of B cell depletion therapy on lung and skin involvement in diffuse systemic sclerosis. Seminars in arthritis and rheumatism; 2015: Elsevier.

Warrick JH, Bhalla M, Schabel SI, Silver RM. High resolution computed tomography in early scleroderma lung disease. The Journal of rheumatology. 1991;18(10):1520-8.

Tashkin DP, Elashoff R, Clements PJ, Goldin J, Roth MD, Furst DE, et al. Cyclophosphamide versus placebo in scleroderma lung disease. New England Journal of Medicine. 2006;354(25):2655-66.

Hoyles RK, Ellis RW, Wellsbury J, Lees B, Newlands P, Goh NS, et al. A multicenter, prospective, randomized, double‐blind, placebo‐controlled trial of corticosteroids and intravenous cyclophosphamide followed by oral azathioprine for the treatment of pulmonary fibrosis in scleroderma. Arthritis & Rheumatism: Official Journal of the American College of Rheumatology. 2006;54(12):3962-70.

Van den Hoogen F, Boerbooms A, Swaak A, Rasker J, Van Lier H, Van De Putte L. Comparison of methotrexate with placebo in the treatment of systemic sclerosis: a 24 week randomized double-blind trial, followed by a 24 week observational trial. Rheumatology. 1996;35(4):364-72.

Pope JE, Bellamy N, Seibold JR, Baron M, Ellman M, Carette S, et al. A randomized, controlled trial of methotrexate versus placebo in early diffuse scleroderma. Arthritis & Rheumatism: Official Journal of the American College of Rheumatology. 2001;44(6):1351-8.

Lateef O, Shakoor N, Balk RA. Methotrexate pulmonary toxicity. Expert opinion on drug safety. 2005;4(4):723-30.

Berghen N, Vulsteke J-B, Westhovens R, Lenaerts J, De Langhe E. Rituximab in systemic autoimmune rheumatic diseases: indications and practical use. Acta Clinica Belgica. 2018.

Cvetković RS, Perry CM. Spotlight on rituximab in non-Hodgkin lymphoma and chronic lymphocytic leukemia. BioDrugs. 2006;20(4):253-7.

Bassel M, Hudson M, Taillefer SS, Schieir O, Baron M, Thombs BD. Frequency and impact of symptoms experienced by patients with systemic sclerosis: results from a Canadian National Survey. Rheumatology. 2011;50(4):762-7.

Sandusky S, McGuire L, Smith M, Wigley F, Haythornthwaite J. Fatigue: an overlooked determinant of physical function in scleroderma. Rheumatology. 2009;48(2):165-9.

Murphy SL, Kratz AL, Whibley D, Poole JL, Khanna D. Fatigue and its association with social participation, functioning, and quality of life in systemic sclerosis. Arthritis care & research. 2021;73(3):415-22.

Sierakowska M, Doroszkiewicz H, Sierakowska J, Olesińska M, Grabowska-Jodkowska A, Brzosko M, et al. Factors associated with quality of life in systemic sclerosis: a cross-sectional study. Quality of Life Research. 2019;28(12):3347-54.

Schnitzer M, Hudson M, Baron M, Steele R. Disability in systemic sclerosis—a longitudinal observational study. The Journal of Rheumatology. 2011;38(4):685-92.

Published

17-09-2022

How to Cite

Madhloom, O. S., & Al hamadani, A. mohammed. (2022). The effect of rituximab on systemic sclerosis: A systematic review and meta-analysis. International Journal of Health Sciences, 6(S7), 4345–4364. https://doi.org/10.53730/ijhs.v6nS7.12801

Issue

Section

Peer Review Articles