drug adverse effects of tumor necrosis factor (TNF) inhibitors

^[1]^[2]^[3]^[4]^[5]^[6]^[7]^[8]^[9]^[10]^[11]^[12]

Adverse effects

pancytopenia^[2]
2-fold increased risk of infections^[3]
- increased risk of soft tissue & skin infection
- increased risk of intracellular bacterial infection
  - tuberculosis (increased risk of reactivation TB)^[6]
  - Listeria monocytogenes (non-bloody diarrhea, encephalitis, dairy)^[5]
  - Salmonella ?
  - Legionella^[5]
pulmonary & disseminated histoplasmosis, coccidioidomycosis, blastomycosis & other opportunistic infections are not consistently recognized in patients taking TNF-alpha blockers; this has resulted in delays in appropriate treatment, & death; empiric antifungal treatment indicated for suspected disseminated mycosis in patients taking TNF-alpha blocker
increased risk of cancer
- increased risk of lymphoma & other cancers associated with use in children & adolescents^[1]
- not associated with an increase in overall cancer risk^[4]
- higher risk of lymphoma risk than the general population, but not higher than those taking traditional DMARDs
- increased risk for nonmelanoma skin cancer
- low risk of cancers^[8]
drug-induced lupus^[2]
cutaneous reactions common^[7]
- psoriasiform dermatitis (most common)^[9]
- cutaneous autoimmune disease
  - subacute cutaneous lupus erythematosus^[2]
- referral to a dermatologist can help keep patients ontreatment^[9]
heart failure^[2]
demyelinating disorders^[2]
increased risk of inflammatory CNS diseases, especially demyelinating diseases^[12]
use in 3rd trimester for inflammatory bowel disease not associated with adverse birth outcomes^[10]

More general terms

drug adverse effect(s)

References

↑ ^1.0 ^1.1 FDA MedWatch Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) August 2009 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm175843.htm
↑ ^2.0 ^2.1 ^2.2 ^2.3 ^2.4 ^2.5 Medical Knowledge Self Assessment Program (MKSAP) 14, 18. American College of Physicians, Philadelphia 2006, 2018.
Medical Knowledge Self Assessment Program (MKSAP) 19 Board Basics. An Enhancement to MKSAP19. American College of Physicians, Philadelphia 2022
↑ ^3.0 ^3.1 Komano Y et al. Incidence and risk factors for serious infection in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors: A report from the Registry of Japanese Rheumatoid Arthritis Patients for Longterm Safety. J Rheumatol 2011 Jul; 38:1258. PMID: https://www.ncbi.nlm.nih.gov/pubmed/21498482
↑ ^4.0 ^4.1 Mariette X et al Malignancies associated with tumour necrosis factor inhibitors in registries and prospective observational studies: a systematic review and meta-analysis Ann Rheum Dis doi:10.1136/ard.2010.149419 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/21885875 <Internet> http://ard.bmj.com/content/early/2011/07/29/ard.2010.149419.abstract
↑ ^5.0 ^5.1 ^5.2 FDA MedWatch 09-09-11 Tumor Necrosis Factor-alpha (TNF-alpha) Blockers: Label Change - Boxed Warning Updated for Risk of Infection from Legionella and Listeria including Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab) http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm270977.htm
↑ ^6.0 ^6.1 Dixon WG et al, Rates of serious infection, including site-specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti-tumor necrosis factor therapy. Arthritis Rheum 2006, 54:2368 PMID: https://www.ncbi.nlm.nih.gov/pubmed/16868999
Mohan AK, Cote TR, Block JA, Manadan AM, Siegel JN, Braun MM. Tuberculosis following the use of etanercept, a tumor necrosis factor inhibitor. Clin Infect Dis. 2004 Aug 1;39(3):295-9. Epub 2004 Jul 16. PMID: https://www.ncbi.nlm.nih.gov/pubmed/15306993
Costamagna P et al, tuyberculosis associated with blocking agents against tumor necrosis factor-alpha - California, 2002-2003, MMWR Morb Mortal Wkly Rep 2004, Aug 6; 53:683-86
Keane J. Tumor necrosis factor blockers and reactivation of latent tuberculosis. Clin Infect Dis. 2004 Aug 1;39(3):300-2. Epub 2004 Jul 16. No abstract available. PMID: https://www.ncbi.nlm.nih.gov/pubmed/15306994
Singh JA et al Risk of serious infection in biological treatment of patients with rheumatoid arthritis: a systematic review and meta-analysis. Lancet. May 11, 2015 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25975452 <Internet> http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2814%2961704-9/abstract
Dixon WG. Rheumatoid arthritis: Biological drugs and risk of infection. Lancet 2015 May 11 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25975453 <Internet> http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2814%2961907-3/abstract
↑ ^7.0 ^7.1 Hernandez MV et al. Cutaneous adverse events during treatment of chronic inflammatory rheumatic conditions with tumor necrosis factor antagonists: Study using the Spanish Registry of Adverse Events of Biological Therapies in Rheumatic Diseases. Arthritis Care Res (Hoboken) 2013 Dec; 65:2024 PMID: https://www.ncbi.nlm.nih.gov/pubmed/23926075
↑ ^8.0 ^8.1 Andersen NN et al. Association between tumor necrosis factor- alpha antagonists and risk of cancer in patients with inflammatory bowel disease. JAMA 2014 Jun 18; 311:2406 PMID: https://www.ncbi.nlm.nih.gov/pubmed/24938563
↑ ^9.0 ^9.1 ^9.2 Cleynen I et al Characteristics of Skin Lesions Associated With Anti-Tumor Necrosis Factor Therapy in Patients With Inflammatory Bowel Disease: A Cohort Study. Ann Intern Med. Published online 8 December 2015 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26641955 <Internet> http://annals.org/article.aspx?articleid=2474360
↑ ^10.0 ^10.1 Bachert A Anti-TNF Therapy Seems Safe in Pregnant Women with IBD.
Use in third trimester not tied to adverse birth outcomes. MedPage Today Dec 11, 2016 http://www.medpagetoday.com/MeetingCoverage/AIBD/61998
↑ Centers for Disease Control and Prevention (CDC). Tuberculosis associated with blocking agents against tumor necrosis factor-alpha--California, 2002-2003. MMWR Morb Mortal Wkly Rep 2004 Aug 6; 53:683. PMID: https://www.ncbi.nlm.nih.gov/pubmed/15295313 Free full text
↑ ^12.0 ^12.1 Xie W, Sun Y, Zhang W, Zhu N, Xiao S et al Risk of Inflammatory Central Nervous System Diseases After Tumor Necrosis Factor-Inhibitor Treatment for Autoimmune Diseases: A Systematic Review and Meta-Analysis. JAMA Neurol. 2024 Oct 21. PMID: https://www.ncbi.nlm.nih.gov/pubmed/39432288

[ref1-1] 1.0 ^1.1 FDA MedWatch Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) August 2009 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm175843.htm

[ref2-2] 2.0 ^2.1 ^2.2 ^2.3 ^2.4 ^2.5 Medical Knowledge Self Assessment Program (MKSAP) 14, 18. American College of Physicians, Philadelphia 2006, 2018.
Medical Knowledge Self Assessment Program (MKSAP) 19 Board Basics. An Enhancement to MKSAP19. American College of Physicians, Philadelphia 2022

[ref3-3] 3.0 ^3.1 Komano Y et al. Incidence and risk factors for serious infection in patients with rheumatoid arthritis treated with tumor necrosis factor inhibitors: A report from the Registry of Japanese Rheumatoid Arthritis Patients for Longterm Safety. J Rheumatol 2011 Jul; 38:1258. PMID: https://www.ncbi.nlm.nih.gov/pubmed/21498482

[ref4-4] 4.0 ^4.1 Mariette X et al Malignancies associated with tumour necrosis factor inhibitors in registries and prospective observational studies: a systematic review and meta-analysis Ann Rheum Dis doi:10.1136/ard.2010.149419 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/21885875 <Internet> http://ard.bmj.com/content/early/2011/07/29/ard.2010.149419.abstract

[ref5-5] 5.0 ^5.1 ^5.2 FDA MedWatch 09-09-11 Tumor Necrosis Factor-alpha (TNF-alpha) Blockers: Label Change - Boxed Warning Updated for Risk of Infection from Legionella and Listeria including Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab) http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm270977.htm

[ref6-6] 6.0 ^6.1 Dixon WG et al, Rates of serious infection, including site-specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti-tumor necrosis factor therapy. Arthritis Rheum 2006, 54:2368 PMID: https://www.ncbi.nlm.nih.gov/pubmed/16868999
Mohan AK, Cote TR, Block JA, Manadan AM, Siegel JN, Braun MM. Tuberculosis following the use of etanercept, a tumor necrosis factor inhibitor. Clin Infect Dis. 2004 Aug 1;39(3):295-9. Epub 2004 Jul 16. PMID: https://www.ncbi.nlm.nih.gov/pubmed/15306993
Costamagna P et al, tuyberculosis associated with blocking agents against tumor necrosis factor-alpha - California, 2002-2003, MMWR Morb Mortal Wkly Rep 2004, Aug 6; 53:683-86
Keane J. Tumor necrosis factor blockers and reactivation of latent tuberculosis. Clin Infect Dis. 2004 Aug 1;39(3):300-2. Epub 2004 Jul 16. No abstract available. PMID: https://www.ncbi.nlm.nih.gov/pubmed/15306994
Singh JA et al Risk of serious infection in biological treatment of patients with rheumatoid arthritis: a systematic review and meta-analysis. Lancet. May 11, 2015 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25975452 <Internet> http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2814%2961704-9/abstract
Dixon WG. Rheumatoid arthritis: Biological drugs and risk of infection. Lancet 2015 May 11 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25975453 <Internet> http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2814%2961907-3/abstract

[ref7-7] 7.0 ^7.1 Hernandez MV et al. Cutaneous adverse events during treatment of chronic inflammatory rheumatic conditions with tumor necrosis factor antagonists: Study using the Spanish Registry of Adverse Events of Biological Therapies in Rheumatic Diseases. Arthritis Care Res (Hoboken) 2013 Dec; 65:2024 PMID: https://www.ncbi.nlm.nih.gov/pubmed/23926075

[ref8-8] 8.0 ^8.1 Andersen NN et al. Association between tumor necrosis factor- alpha antagonists and risk of cancer in patients with inflammatory bowel disease. JAMA 2014 Jun 18; 311:2406 PMID: https://www.ncbi.nlm.nih.gov/pubmed/24938563

[ref9-9] 9.0 ^9.1 ^9.2 Cleynen I et al Characteristics of Skin Lesions Associated With Anti-Tumor Necrosis Factor Therapy in Patients With Inflammatory Bowel Disease: A Cohort Study. Ann Intern Med. Published online 8 December 2015 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26641955 <Internet> http://annals.org/article.aspx?articleid=2474360

[ref10-10] 10.0 ^10.1 Bachert A Anti-TNF Therapy Seems Safe in Pregnant Women with IBD.
Use in third trimester not tied to adverse birth outcomes. MedPage Today Dec 11, 2016 http://www.medpagetoday.com/MeetingCoverage/AIBD/61998

[ref11-11] Centers for Disease Control and Prevention (CDC). Tuberculosis associated with blocking agents against tumor necrosis factor-alpha--California, 2002-2003. MMWR Morb Mortal Wkly Rep 2004 Aug 6; 53:683. PMID: https://www.ncbi.nlm.nih.gov/pubmed/15295313 Free full text

[ref12-12] 12.0 ^12.1 Xie W, Sun Y, Zhang W, Zhu N, Xiao S et al Risk of Inflammatory Central Nervous System Diseases After Tumor Necrosis Factor-Inhibitor Treatment for Autoimmune Diseases: A Systematic Review and Meta-Analysis. JAMA Neurol. 2024 Oct 21. PMID: https://www.ncbi.nlm.nih.gov/pubmed/39432288

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drug adverse effects of tumor necrosis factor (TNF) inhibitors

Adverse effects

More general terms

References

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