@article{3347556,
    title = "Infection profile of immune-modulatory drugs used in autoimmune diseases: Analysis of summary of product characteristic data",
    author = "Dey, M. and Bechman, K. and Zhao, S. and Fragoulis, G.E. and Smith, C. and Cope, A. and Nikiphorou, E. and Hyrich, K.L. and Galloway, J.",
    journal = "RMD Open: Rheumatic & Musculoskeletal Diseases",
    year = "2022",
    volume = "8",
    number = "2",
    publisher = "BMJ Publishing Group",
    issn = "2056-5933",
    doi = "10.1136/rmdopen-2022-002621",
    keywords = "abatacept;  adalimumab;  alemtuzumab;  anakinra;  azathioprine;  baricitinib;  belimumab;  beta interferon;  canakinumab;  certolizumab pegol;  cladribine;  cyclosporine;  disease modifying antirheumatic drug;  dupilumab;  eculizumab;  etanercept;  filgotinib;  fingolimod;  golimumab;  guselkumab;  infliximab;  ixekizumab;  Janus kinase inhibitor;  leflunomide;  methotrexate;  mitoxantrone;  mycophenolate mofetil;  natalizumab;  ocrelizumab;  ravulizumab;  rituximab;  salazosulfapyridine;  sarilumab;  secukinumab;  siponimod;  sphingosine 1 phosphate receptor;  teriflunomide;  tocilizumab;  tofacitinib;  tumor necrosis factor;  upadacitinib;  ustekinumab;  vedolizumab;  antirheumatic agent;  certolizumab pegol, Article;  Aspergillus;  autoimmune disease;  Blastomyces;  Candida;  clinical article;  controlled study;  Epstein Barr virus;  fungus;  Herpes simplex virus;  Histoplasma;  human;  infection;  infectious agent;  lower respiratory tract infection;  Mycobacterium avium;  Mycobacterium tuberculosis;  nonhuman;  prevalence;  tinea;  upper respiratory tract;  upper respiratory tract infection;  urinary tract infection;  autoimmune disease;  rheumatoid arthritis;  spondylarthritis, Antirheumatic Agents;  Arthritis, Rheumatoid;  Autoimmune Diseases;  Certolizumab Pegol;  Humans;  Spondylarthritis",
    abstract = "Objective Serious infection remains a concern when prescribing immune-modulatory drugs for immune-mediated inflammatory diseases. The 'summary of product characteristics' (SmPCs) provide information on adverse events for example, infections, from clinical trials and postmarketing pharmacovigilance. This review aimed to compare infection frequency, site and type across immune-modulatory drugs, reported in SmPCs. Methods The Electronic Medicines Compendium was searched for commonly prescribed immune-modulatory drugs used for: rheumatoid arthritis, spondyloarthritis, connective tissue disease, autoimmune vasculitis, autoinflammatory syndromes, inflammatory bowel disease, psoriasis, multiple sclerosis and/or other rarer conditions. Information was extracted on infection frequency, site and organisms. Frequency was recorded as per the SmPCs: very common (≥1/10); common (≥1/100 to<1/10); uncommon (≥1/1,000 to<1/100); rare (≥1/10,000 to<1/1,000); very rare (<1/10 000). Results 39 drugs were included, across 20 indications: 9 conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), 6 targeted synthetic DMARDs, 24 biologic (b)DMARDs. Twelve infection sites were recorded. Minimal/no site information was available for most csDMARDs, certolizumab pegol and rituximab. Upper respiratory tract was the most common site, especially with bDMARDs. Lower respiratory, ear/nose/throat and urinary tract infections were moderately common, with clustering within drug groups. Data for 27 pathogens were recorded, majority viruses, with herpes simplex and zoster and influenza most frequent. Variable/absent reporting was noted for opportunistic and certain high-prevalence infections for example, Epstein-Barr. Conclusion Our findings show differences between drugs and can aid treatment decisions alongside real-world safety data. However, data are likely skewed by trial selection criteria and varying number of trials per drug and highlight the need for robust postmarketing pharmacovigilance. ©"
}