The effect of Remicade Trough Level on Disease Activity in a Selected Sample of Iraqi Rheumatoid Arthritis Patients
DOI:
https://doi.org/10.31351/vol33iss(4SI)pp214-221Keywords:
Remicade Trough LevelAbstract
Rheumatoid arthritis is a lifelong autoimmune arthritic disorder that mostly impacts the small joints, although it can also affect the larger joints. Infliximab is a chimeric monoclonal IgG antibody that specifically targets tumor necrosis factor, a crucial material associated with pathogenic processes. Remicade is an original medication of infliximab. Monitoring the trough level is essential for managing disease activity, while C-reactive protein (CRP) and Erythrocyte Sedimentation Rate (ESR) are utilized to detect inflammation and anticipate the drug's effectiveness. The study was designed to assess the impact of Remicade trough level on both disease activity and inflammatory biomarkers. A cross-sectional, observational research was carried out at Baghdad Teaching Hospital, involving forty-eight patients who had been diagnosed with rheumatoid arthritis (RA) based on the ACR/EULAR 2010 criteria and were on treatment with Remicade. After 3 months after starting Remicade treatment, measurements were taken for Remicade trough level, CDAI, ESR, and CRP parameters. After a 3-month course of Remicade therapy, the individuals were categorized into four distinct groups based on their CDAI scores (remission, mild, moderate, and severe groups). The trough level of Remicade during remission is 5.6±0.1248µg/mL. In the mild, moderate, and severe groups, the trough levels of Remicade are 4.22±0.1244µg/mL, 2.342±0.1505µg/mL, and 0.72±0.2518µg/mL, respectively. The CDAI score was considerably greater in the severe disease activity group and reduced gradually in the moderate, mild, and remission groups, respectively. The CDAI scores for the severe group are 20.83+-3.219, for the moderate group are 14.77+-0.6218, for the mild group are 5.5+-0.6337, and for the remission, group are 1.34+-0.1086. Furthermore, the findings indicate an inverse correlation between the Remicade trough level and the levels of ESR and CRP. The reduction in the CDAI score, ESR, and CRP was associated with a high level of Remicade in the bloodstream. This also implies that the increase in CDAI score, ESR, and CRP in patients with rheumatoid arthritis may be caused by a drop in the amount of Remicade in the bloodstream.
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References
Mohammed AM, Zayni SM, AL-Anee MM, Corial FI, Rubaee AA. Diagnostic and Predictive Values of IL-6 in a Group of Iraqi Patients with Rheumatoid Arthritis. J Fac Med Baghdad [Internet]. 2023 Jul 1;65(2). DOI: https://doi.org/10.32007/jfacmedbagdad.2044
Oglah AA, Mohammed KIA, Alosami MH. A Comparative Study of Serum Amyloid A2 with Anti-cyclic Citrullinated Peptide antibody in the prognosis of a Group of Rheumatoid Arthritis Patients in Iraq. J Fac Med Baghdad. 2022 Oct 17;64(3):153–8.
Zahraa Adnan GA, Inas K. Sharquie, Faiq I. Gorial. A novel Link of Serum IL-39 Levels in Patients with Rheumatoid Arthritis [Internet]. 2023 April 30;64(4). DOI: https://doi.org/10.24996/ijs.2023.64.4.8
Bilal M, Qindeel M, Nunes LV, Duarte MTS, Ferreira LFR, Soriano RN, et al. Marine-Derived Biologically Active Compounds for the Potential Treatment of Rheumatoid Arthritis. Mar Drugs. 2020 Dec 29;19(1):10.
Rashid MK. Prevalence Rate of Rheumatoid Arthritis among Patients Attending Rheumatology Consultation Clinic at Baquba Teaching Hospital. Diyala J Med. 2023 Apr 5;24(1):54–65.
Al-Rawi ZS, Alazzawi AJ, Alajili FM, Alwakil R. Rheumatoid arthritis in population samples in Iraq. Ann Rheum Dis. 1978 Feb;37(1):73–5.
Mathkhor AJ, Khoudhairy AHA& AS. Demographic, clinical, and serological features of Iraqi patients with rheumatoid arthritis: evaluation of 470 patients. Int J Clin Rheumatol. 2021 Mar 29;16(3):099.
Faiq MK, Kadhim DJ, Gorial FI. The Belief about Medicines among a Sample of Iraqi Patients with Rheumatoid Arthritis. Iraqi J Pharm Sci P-ISSN 1683 - 3597 E-ISSN 2521 - 3512. 2019 Dec 22;28(2):134–41.
Khalid KB, Humadi YA, Gorial FI, Awadh NI, Mahmood SJ, Mahmood RS. Evaluation of oral health-related quality of life in a sample of Iraqi patients with rheumatoid arthritis: a case-control study. J Oral Med Oral Surg. 2024;30(1):2.
Abbas NR, Mousawy KM, Salman S, Al-Kafaji J. Some Immunological Profile of Rheumatoid Arthritis. J Fac Med Baghdad. 2006 Oct 1;48(3):293–6.
Al Ani NA, Gorial FI, Al-Sulaitti S, Humadi JA, Awadh NI, Mounir M, et al. Review of biologics, biosimilars, and intended copies in rheumatology, and current practice in Iraq. Open Access Rheumatol Res Rev. 2018 Dec 24;11:1–9.
Abbasi M, Mousavi MJ, Jamalzehi S, Alimohammadi R, Bezvan MH, Mohammadi H, et al. Strategies toward rheumatoid arthritis therapy; the old and the new. J Cell Physiol. 2019;234(7):10018–31.
Al-Herz A, Saleh K, Al-Awadhi A, Al-Kandari W, Hasan E, Ghanem A, et al. Accessibility to biologics and its impact on disease activity and quality of life in patients with rheumatoid arthritis in Kuwait. Clin Rheumatol. 2021 May;40(5):1759–65.
Ali H Mohammed S, Al-Khedairy EBH. Formulation and In Vitro Evaluation of Taste-Masked Prednisolone Orodispersible Tablets. J Fac Med Baghdad. 2023 Oct 1;65(3):192–8.
Yaseen M Arabi, Yasser Mandourah, Fahad Al-Hameed, Anees A Sindi, Ghaleb A Almekhlafi, Mohamed A Hussein et al. Corticosteroid Therapy for Critically Ill Patients with Middle East Respiratory Syndrome | American Journal of Respiratory and Critical Care Medicine. 2018 Mar 15;197(6):757-767
Abeer M Mohammed, Sarmad M Zayni, Muhammad M A, Faiq I Corial, Adnan Al- Rubaee. Diagnostic potential of interleukin-40 (IL-40) in rheumatoid arthritis patients [Internet]. 2023 Feb;65(2).
Alawneh K, Al-Mistarehi AH, Qandeel A, Jaber R, Alomari S, Kheirallah KA. The Safety and Effectiveness of Infliximab Biosimilar in Managing Rheumatoid Arthritis: A Real-Life Experience from Jordan. Int J Clin Pract. 2022 Aug 26. DOI: 10.1155/2022/3406783
Cohen SB, Kremer JM, Dandreo KJ, Reed GW, Magner R, Shan Y, et al. Outcomes of infliximab dose escalation in patients with rheumatoid arthritis. Clin Rheumatol. 2019 Sep;38(9):2501–8.
Ho Lee Y, Gyu Song G. Comparative efficacy and safety of tumor necrosis factor inhibitors and their biosimilars in patients with rheumatoid arthritis having an insufficient response to methotrexate : A network meta-analysis. Z Rheumatol. 2023 Apr;82(3):248–55.
Ishii-Watabe A, Kuwabara T. Biosimilarity assessment of biosimilar therapeutic monoclonal antibodies. Drug Metab Pharmacokinet. 2019 Feb;34(1):64–70.
Burkard T, Vallejo-Yagüe E, Lauper K, Finckh A, Hügle T, Burden AM. Longitudinal associations between body mass index and changes in disease activity and radiographic progression in rheumatoid arthritis patients treated with infliximab. RMD Open. 2023 Oct;9(4):e003396.
Baker JF, Bakewell C, Dikranian A, Lam G, O’Brien J, Moore PC, et al. Characteristics and 6-Month Outcomes in Patients with Rheumatoid Arthritis Initiating Infliximab Biosimilar IFX-dyyb in a Real-World Setting. Rheumatol Ther. 2024 Mar 20;
Abdul-Qahar ZH, Mahmood HG, Rasheed M k. Measurement of Anti-Cyclic Citrullinated Peptide, Leptin Hormone, and Lipoprotein (a) In Iraqi Female Patients with Rheumatoid Arthritis. J Fac Med Baghdad. 2014 Oct 1;56(3):305–7.
Saleh HH, Khadim DJ, Hussein RJ. Correlation between Therapeutic Drug Monitoring of Infliximab Serum Trough Levels and other Biomarkers in Iraqi Patients with Crohn’s Disease. Al-Rafidain J Med Sci ISSN 2789-3219. 2024 Mar 24;6(1):239–45.
Al-Hamamy HR, Al-Turfy IA, Abdul-Reda FS. Infliximab Therapy in Iraqi Patients with Moderate to Severe Psoriasis. J Cosmet Dermatol Sci Appl. 2015 Mar 20;5(2):78–85.
Sandström T, Rantalaiho V, Yli-Kerttula T, Kautiainen H, Malmi T, Karjalainen A, et al. Cervical Spine Involvement among Patients with Rheumatoid Arthritis Treated Actively with Treat-to-target Strategy: 10-year Results of the NEO-RACo Study. J Rheumatol. 2020 Aug 1;47(8):1160–4.
Al-Kinani KK, Ibrahim MJ, Al-Zubaidi RF, Younus MM, Ramadhan SH, Kadhim HJ, et al. Iraqi regulatory authority current system and experience with biosimilars. Regul Toxicol Pharmacol. 2020 Nov 1;117:104768.
Ishii-Watabe A, Kuwabara T. Biosimilarity assessment of biosimilar therapeutic monoclonal antibodies. Drug Metab Pharmacokinet. 2019 Feb;34(1):64–70.
Fadhil HR, Al-Jumaili AA, Al-Ani NA. Cost-effectiveness Analysis of Reference Infliximab (Remicade) Compared to its Biosimilar (Remsima) in Iraqi Patients with Rheumatoid Arthritis (Conference Paper )#. Iraqi J Pharm Sci P-ISSN 1683 - 3597 E-ISSN 2521 - 3512. 2022;31(Suppl.):100–10.
Rider LG, Aggarwal R, Pistorio A, Bayat N, Erman B, Feldman BM, et al. 2016 American College of Rheumatology (ACR) - European League Against Rheumatism (EULAR) Criteria for Minimal, Moderate and Major Clinical Response for Juvenile Dermatomyositis: An International Myositis Assessment and Clinical Studies Group/Paediatric Rheumatology International Trials Organisation Collaborative Initiative. Ann Rheum Dis. 2017 May;76(5):782–91.
van der Heijde DM, van ’t Hof M, van Riel PL, van de Putte LB. Development of a disease activity score based on judgment in clinical practice by rheumatologists. J Rheumatol. 1993 Mar;20(3):579–81.
Singh H, Kumar H, Handa R, Talapatra P, Ray S, Gupta V. Use of Clinical Disease Activity Index Score for Assessment of Disease Activity in Rheumatoid Arthritis Patients: An Indian Experience. Arthritis. 2011;2011:146398.
Hetland ML, Christensen IJ, Tarp U, Dreyer L, Hansen A, Hansen IT, et al. Direct comparison of treatment responses, remission rates, and drug adherence in patients with rheumatoid arthritis treated with adalimumab, etanercept, or infliximab: results from eight years of surveillance of clinical practice in the nationwide Danish DANBIO registry. Arthritis Rheum. 2010 Jan;62(1):22–32.
Abuhelwa AY, Hopkins AM, Sorich MJ, Proudman S, Foster DJR, Wiese MD. Association between obesity and remission in rheumatoid arthritis patients treated with disease-modifying anti-rheumatic drugs. Sci Rep. 2020 Oct 29;10(1):18634.
Khader Y, Beran A, Ghazaleh S, Lee-Smith W, Altorok N. Predictors of remission in rheumatoid arthritis patients treated with biologics: a systematic review and meta-analysis. Clin Rheumatol. 2022 Dec 1;41(12):3615–27.
Yu C, Jin S, Wang Y, Jiang N, Wu C, Wang Q, et al. Remission rate and predictors of remission in patients with rheumatoid arthritis under treat-to-target strategy in real-world studies: a systematic review and meta-analysis. Clin Rheumatol. 2019 Mar;38(3):727–38.
Hassan EF, Kadhim D j, Younus M m. Safety Profile of Biological Drugs in Clinical Practice: A Retrospective Pharmacovigilance Study. Iraqi J Pharm Sci P-ISSN 1683 - 3597 E-ISSN 2521 - 3512. 2022 Jun 9;31(1):32–42.
Al-Jumaili AA, Fahmi HL. Understanding the Experience of Hospital Pharmacists with the Effectiveness, Safety, Adverse Drug Reaction Reporting and Interchangeability of Biopharmaceutical Medicines. Iraqi J Pharm Sci P-ISSN 1683 - 3597 E-ISSN 2521 - 3512. 2022 Jun 12;31(1):72–86.
Jassim NA. Predictors of Response to (Etanercept) in the Treatment of Iraqi Patients with Active Rheumatoid Arthritis. J Fac Med Baghdad. 2015 Apr 5;57(1):35–9.
Curci D, Lucafò M, Cifù A, Fabris M, Bramuzzo M, Martelossi S, et al. Pharmacogenetic variants of infliximab response in young patients with inflammatory bowel disease. Clin Transl Sci. 2021 Nov;14(6):2184–92.
Raheem SS, Alkhatib MM, Jabber A jawad. ROLE OF TNF- α AND IL-10 IN RHEUMATOID ARTHRITIS DISEASE AND THE ASSOCIATION WITH SOME HLA -11 DR AND DQ ALLELES. Pak J Biotechnol. 2019 Mar 25;16(1):1–4.
Abbas NR, Obeidy ESA, Naim SNA, Kadim AE. Correlation between some immunological parameters and clinical presentation in RA patients. J Fac Med Baghdad. 2008 Jul 1;50(2):235–40.
Talotta R, Berzi A, Doria A, Batticciotto A, Ditto MC, Atzeni F, et al. The Immunogenicity of Branded and Biosimilar Infliximab in Rheumatoid Arthritis According to Th9-Related Responses. Int J Mol Sci. 2017 Oct 12;18(10):2127.
Lin YJ, Anzaghe M, Schülke S. Update on the Pathomechanism, Diagnosis, and Treatment Options for Rheumatoid Arthritis. Cells. 2020 Apr;9(4):880.
Al-Hassan AAH. Role of Pro- and Anti-Inflammatory Cytokines in Rheumatoid Arthritis: Correlation with Disease Activity. J Fac Med Baghdad. 2010 Oct 3;52(3):286–91.
Thanoon IA, Tawfik NO, Hussin FN. Oxidative Stress & C – Reactive Protein In Patients With Arthritis. J Fac Med Baghdad. 2007 Jul 1;49(2):227–30.
Tutan D, Doğan AG. Pan-Immune-Inflammation Index as a Biomarker for Rheumatoid Arthritis Progression and Diagnosis. Cureus. 2023 Oct;15(10):e46609.
Aletaha D, Wang X, Zhong S, Florentinus S, Monastiriakos K, Smolen JS. Differences in disease activity measures in patients with rheumatoid arthritis who achieved DAS, SDAI, or CDAI remission but not Boolean remission. Semin Arthritis Rheum. 2020 Apr 1;50(2):276–84.
Shakir MJ, Hussein AA. Assessment of Serum Interleukin-2, -4 and C-reactive protein Levels in patients with Giardiasis and Cryptosporidiosis. J Fac Med Baghdad. 2014 Oct 1;56(3):313–7.
Yoshii I, Sawada N, Chijiwa T, Kokei S. Impact of sustaining SDAI remission for preventing incident of bone fragility fracture in patient with rheumatoid arthritis. Ann Rheum Dis. 2022 Feb 1;81(2):296–9.
Al-Karkhi MA, Al-Ani MM, Jassim NA. Development of Anti-bodies against Infliximab in Iraqi Patients with Rheumatoid Arthritis. J Fac Med Baghdad. 2015 Oct 1;57(3):241–3.
Ding N, Luo M, Wen YH, Li RY, Bao QY. The Effects of Non-Surgical Periodontitis Therapy on the Clinical Features and Serological Parameters of Patients Suffering from Rheumatoid Arthritis as Well as Chronic Periodontitis. J Inflamm Res. 2022;15:177–85.
Aghdashi MA, Seyedmardani S, Ghasemi S, Khodamoradi Z. Evaluation of Serum Calprotectin Level and Disease Activity in Patients with Rheumatoid Arthritis. Curr Rheumatol Rev. 2019;15(4):316–20.
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