Systematic review and meta-analysis of adverse effects associated with monoclonal antibodies used in different inflammatory conditions and breast cancer

Mathur R, Raina P, Sweety, Kumar D, Goyal RK 

Delhi Pharmaceutical Sciences and Research University Pushp Vihar, Sec III, MB Road, New Delhi, INDIA


During the COVID-19 pandemic, the clinical management of patients with long- standing disorders of immune system, as in autoimmune and inflammatory conditions (rheumatoid arthritis(RA), multiple sclerosis(MS)) or consequence of cancer chemotherapy (immunosuppression in breast cancer(BC)) has been fraught with challenges. First, when compared to the general population, these patients have a higher risk of COVID-19 infection, second, the outcomes are worsened by COVID-19 infection and third, during lockdowns, these patients experienced increased pain and functional impairment that severely affected the quality of life (QoL) and mental health. The use of monoclonal antibodies (mAbs) have become the mainstay for the treatment of these indications, but they are associated with various adverse events (AEs), regarding which there is paucity of data. In order to aid in rational treatment choices, the safety profile of mAbs, each approved for the treatment of RA (Sarilumab, Tocilizumab, Adalimumab, Golimumab, Infliximab, Rituximab), MS (Natalizumab, Ocrelizumab, Alemtuzumab) and BC (trastuzumab) was statistically compared. In accordance with the PRISMA statement, the systematic literature review was conducted using databases such as PubMed, Cochrane library and Science Direct. The primary outcome was the occurrence of AEs with the use of approved mAbs and the data was synthesized using GraphPad Prism and Medcalc. The safety of three monoclonal antibodies—natalizumab (NTZ), ocrelizumab (OCR), and alemtuzumab (ALM), used for the treatment of both relapsing and progressive forms of multiple sclerosis (MS) was reviewed from clinical studies published between 2016 and 2020 in the PubMed database. The most common AEs associated with the use of NTZ, OCR, and ALM were infection (UTI, RTI) and infestation. The use of ALM was associated with immune thrombocytopenia (2%), respiratory infections (7%), and thyroid dysfunction (43%), making the use of NTZ and OCR a safer choice for MS. In RA, the highest and lowest percentage of AEs were recorded with Golimumab and Rituximab, respectively. In patients treated for BC, the AEs such as myalgia, nasopharyngitis, hypertension, and reduced ejection fraction were commonest with Trastuzumab biosimilar.  

Article ID: O0401019 (Suppl 1)   RA  Preprint
Received: 08/06/2022 
Accepted: 08/07/2022
Published: 08/08/2022

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