Infection profile of immune-modulatory drugs used in autoimmune diseases: analysis of summary of product characteristic data
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.T...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-11-01
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| Series: | RMD Open |
| Online Access: | https://rmdopen.bmj.com/content/8/2/e002621.full |
| _version_ | 1797778002122113024 |
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| author | Catherine Smith Andrew Cope Elena Nikiphorou Mrinalini Dey James Galloway Kimme L Hyrich Katie Bechman Sizheng Zhao |
| author_facet | Catherine Smith Andrew Cope Elena Nikiphorou Mrinalini Dey James Galloway Kimme L Hyrich Katie Bechman Sizheng Zhao |
| author_sort | Catherine Smith |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T23:11:04Z |
| format | Article |
| id | doaj.art-f084e6b6c15b4020ba7a7c5ae3966d8d |
| institution | Directory Open Access Journal |
| issn | 2056-5933 |
| language | English |
| last_indexed | 2024-03-12T23:11:04Z |
| publishDate | 2022-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | RMD Open |
| spelling | doaj.art-f084e6b6c15b4020ba7a7c5ae3966d8d2023-07-18T05:00:07ZengBMJ Publishing GroupRMD Open2056-59332022-11-018210.1136/rmdopen-2022-002621Infection profile of immune-modulatory drugs used in autoimmune diseases: analysis of summary of product characteristic dataCatherine Smith0Andrew Cope1Elena Nikiphorou2Mrinalini Dey3James Galloway4Kimme L Hyrich5Katie Bechman6Sizheng Zhao7Department of Dermatology, Torbay and South Devon NHS Foundation Trust, Devon, UKCentre for Rheumatic Diseases, King`s College London, London, UKCentre for Rheumatic Diseases, King`s College London, London, UKInstitute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UKDepartment of Rheumatology, King`s College Hospital NHS Foundation Trust, London, UK10 Centre for Epidemiology Versus Arthritis, The University of Manchester and NIHR Manchester Biomedical Research Centre, Manchester University NHS Trust, Manchester, UKAcademic Department of Rheumatology, King`s College London, London, UKVersus Arthritis Centre or Epidemiology, The University of Manchester Centre for Musculoskeletal Research, Manchester, UKObjective 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.https://rmdopen.bmj.com/content/8/2/e002621.full |
| spellingShingle | Catherine Smith Andrew Cope Elena Nikiphorou Mrinalini Dey James Galloway Kimme L Hyrich Katie Bechman Sizheng Zhao Infection profile of immune-modulatory drugs used in autoimmune diseases: analysis of summary of product characteristic data RMD Open |
| title | Infection profile of immune-modulatory drugs used in autoimmune diseases: analysis of summary of product characteristic data |
| title_full | Infection profile of immune-modulatory drugs used in autoimmune diseases: analysis of summary of product characteristic data |
| title_fullStr | Infection profile of immune-modulatory drugs used in autoimmune diseases: analysis of summary of product characteristic data |
| title_full_unstemmed | Infection profile of immune-modulatory drugs used in autoimmune diseases: analysis of summary of product characteristic data |
| title_short | Infection profile of immune-modulatory drugs used in autoimmune diseases: analysis of summary of product characteristic data |
| title_sort | infection profile of immune modulatory drugs used in autoimmune diseases analysis of summary of product characteristic data |
| url | https://rmdopen.bmj.com/content/8/2/e002621.full |
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