Al- Anbar Medical Journal

Efficacy, Safety and Predictors of Response to Rituximab in Treatment of Iraqi Patients with Active Rheumatoid Arthritis

Document Type : Original articles

Authors

Rheumatology Department, College of Medicine, University of Baghdad, Baghdad, Iraq

Abstract

Background: Rituximab (RTX) is an anti-CD20 chimeric monoclonal antibody which effectively depletes B cells and is used for treating rheumatoid arthritis (RA).
Objectives: To assess the efficacy and safety of RTX and to evaluate the predictors of response to RTX in the treatment of Iraqi patients with active RA.
Materials and Methods: An open-labeled single group study that was conducted over 13 months in 65 patients with RA diagnosed according to a 1987 American College of Rheumatology (ACR) criteria. All patients were given 4 doses RTX by intravenous infusion over 6 months 1gm/dose. Each patient was followed at each visit of disease activity, including the Clinical Disease Activity Index (CDAI) and functional class (F Class). Also, we assess 9 different patients' characteristics (age, gender, disease duration, the presence of RF, presence of ACPA, smoking status, previous use of TNF-blocker, the use of methotrexate and BMI) as predictors to RTX.
Results: Data analysis showed significant improvement in CDAI (P value=0. 005) and functional disability (P-value =0. 001), and ESR (P-value =0. 005) with RTX use over 6 months. The analysis also showed that smoking has a negative correlation with response to treatment (p-value = 0.005). A better response was seen in RF-positive group. The other variables had no effects on the response to treatment. The patients who switched from TNF-blocker were (29), and the patients who started on  RTX  were 36 (either due to positive Purified Protein Derivative of a tuberculin test  (PPD) or unavailability of TNF-blocker), results showed same RTX efficacy in both groups.
Conclusion: RTX is effective both clinically on F Class and on  ESR. It is more effective in patients who are not smokers, in those who are seropositive for RF. RTX is relatively safe with few side effects, tolerable by most patients. The most common side effect is a transfusion reaction in the form of a sore throat.

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References
[1]      A. Silman et al., “Proposal to establish a register for the long term surveillance of adverse events in patients with rheumatic diseases exposed to biological agents: the EULAR Surveillance Register for Biological Compounds,” Ann. Rheum. Dis., vol. 59, no. 6, pp. 419–420, 2000.
[2] M. L. D. et al. R. James R., John B, CURRENT Diagnosis and Treatment Rheumatology 3rd ED. Mc Graw Hill education. 2013.
[3]      G. S. et al Firestein GS, Budd RC, etiology and pathogenesis. In: Kelley's Textbook of Rheumatology.9thEd. China, Elsevier. 2013.
[4]      R. S. W. B. et al Doherty M, Musculoskeletal disorders. In: Davidson’s Principles and Practice of Medicine. 21th Ed. London, Elsevier’s Health Sciences Rights Department. 2010.
[5]      A.-A. F. et al Al-Rawi ZS, Alazzawi AJ, “Rheumatoid Arthritis in population samples in Iraq,” Ann Rheum Dis, vol. 37, no. 1, pp. 73–75, 1978.
[6] Al-Saadawi TH., "The association of smoking with disease activity and appearance of extra-articular manifestation in RA patients.," Post-- Grad. Med. J., vol. 12, no. 1, pp. 146–152, 2013.
[7]      F. G. Sweney SE., Harris ED, Clinical features of rheumatoid arthritis. Kelley’s Textbook of Rheumatology. 9thEd. China, Elsevier. 2013.
[8]      D. Aletaha et al., “2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative,” Arthritis Rheum., vol. 62, no. 9, pp. 2569–2581, 2010.
[9]      I. D. Nizar Abdulateef Jassim, Efficacy, Safety and Predictors of response to Etanercept in Treatment of Iraqi Patients with Active RA. Diploma thesis. The University of Baghdad, College of Medicine, Rheumatology Unit. 2013.
[10] M. D. et al Sonya Abraham, Andrew Barr, Arthritis. In Rheumatology Handbook.Imperial College, Press. 2012.
[11]    J. S. Smolen et al., “EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs,” Ann. Rheum. Dis., vol. 69, no. 6, pp. 964–975, 2010.
[12]    M.-J. C. J. Guerry et al., “Recommendations for the use of rituximab in anti-neutrophil cytoplasm antibody-associated vasculitis,” Rheumatology, vol. 51, no. 4, pp. 634–643, 2011.
[13] M. com/drug/Rituxan. Rituximab-342243, "Rituxan (rituximab) dosing, indications, interactions, adverse effects and more. Available from URL:http:/ www. Reference.".
[14] M. J. W. M. Oqbro O. PharmD., "Rituxan Drug Facts, Side Effects, and Dosing, cancer center, cancer a-z list, RTX index, Rituxan drug monograph.," 2016.
[15]    J. C. W. Edwards et al., “Efficacy of B-cell–targeted therapy with rituximab in patients with rheumatoid arthritis,” N. Engl. J. Med., vol. 350, no. 25, pp. 2572–2581, 2004.
[16]    M. F. Luca Q, Sara S., “Cost saving and predictive factors of response to RTX in RA: Salvatore De Vita, Clinic of Rheumatology, University Hospital of Udine, Piazzale S. Maria della Misericordia,” 2012.
[17]    A. Richter et al., "Sustainability of Rituximab Therapy in Different Treatment Strategies: Results of a 3‐Year Follow-up of a German Biologics Register," Arthritis Care Res. (Hoboken)., vol. 66, no. 11, pp. 1627–1633, 2014.
[18] R. F. van Vollenhoven, R. M. Fleischmann, D. E. Furst, S. Lacey, and P. B. Lehane, "Longterm safety of rituximab: final report of rheumatoid arthritis global clinical trial program over 11 years," J. Rheumatol., vol. 42, no. 10, pp. 1761–1766, 2015.
[19]    A. Khan, D. L. Scott, and M. Batley, “Smoking, rheumatoid factor status and responses to rituximab,” Ann. Rheum. Dis., vol. 71, no. 9, pp. 1587–1588, 2012.
[20]    M. A. Lopez-Olivo, M. Amezaga Urruela, L. Mcgahan, E. N. Pollono, and M. E. Suarez-Almazor, “Rituximab for rheumatoid arthritis,” Cochrane Database Syst. Rev., vol. 2017, no. 6, pp. 99–111, 2015.
[21]    J. D. Isaacs et al., “Effect of baseline rheumatoid factor and anticitrullinated peptide antibody serotype on rituximab clinical response: a meta-analysis,” Ann. Rheum. Dis., vol. 72, no. 3, pp. 329–336, 2013.
[22]    J. Wendler et al., “Rituximab in patients with rheumatoid arthritis in routine practice (GERINIS): six-year results from a prospective, multicentre, non-interventional study in 2,484 patients,” Arthritis Res. Ther., vol. 16, no. 2, p. R80, 2014.
[23]    J. Sellam et al., “B cell activation biomarkers as predictive factors for the response to rituximab in rheumatoid arthritis: a six‐month, national, multicenter, open‐label study,” Arthritis Rheum., vol. 63, no. 4, pp. 933–938, 2011.
[24]    R. van Vollenhoven et al., “long-term Safety Of Rituximab: Pooled Analysis Of The Rheumatoid Arthritis Global Clinical Trial Program Over 11 Years.: 2342,” Arthritis Rheum., vol. 65, p. S1000, 2013.
[25]    D. Ennishi et al., “Does rituximab really induce hepatitis C virus reactivation?,” J. Clin. Oncol., vol. 26, no. 28, pp. 4695–4696, 2008.
Al- Anbar Medical Journal
Volume 15, Issue 1
June 2019
Page 16-21
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