Melanoma and non-Melanoma Skin Cancer in Inflammatory Bowel Disease Patients following Tumor Necrosis Factor-α Inhibitor Monotherapy and in Combination with Thiopurines: Analysis of the Food and Drug Administration Adverse Event Reporting System

McKenna, Michael R; Stobaugh, Derrick J.; Deepak, Parakkal

doi:10.15403/jgld.2014.1121.233.mrmk

Cited by 54 publications

(30 citation statements)

References 31 publications

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“…A nested case-control study failed to show a further increased risk in IBD patients with recent or persistent combination therapy (393). An analysis of the FDA Adverse Event Reporting System found that both anti-TNF-α monotherapy and combination therapy with thiopurines increase the risk of melanoma and NMSC in IBD patients(424). Dermatologic screening has been suggested for all patients undergoing anti-TNFα treatment(425,426).…”

mentioning

confidence: 99%

Safety of treatments for inflammatory bowel disease: Clinical practice guidelines of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD)

Biancone

Annese

Ardizzone

et al. 2017

Digestive and Liver Disease

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Inflammatory bowel diseases are chronic conditions of unknown etiology, showing a growing incidence and prevalence in several countries, including Italy. Although the etiology of Crohn's disease and ulcerative colitis is unknown, due to the current knowledge regarding their pathogenesis, effective treatment strategies have been developed. Several guidelines are available regarding the efficacy and safety of available drug treatments for inflammatory bowel diseases. Nevertheless, national guidelines provide additional information adapted to local feasibility, costs and legal issues related to the use of the same drugs. These observations prompted the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD) to establish Italian guidelines on the safety of currently available treatments for Crohn's disease and ulcerative colitis. These guidelines discuss the use of aminosalicylates, systemic and low bioavailability corticosteroids, antibiotics (metronidazole, ciprofloxacin, rifaximin), thiopurines, methotrexate, cyclosporine A, TNFα antagonists, vedolizumab, and combination therapies. These guidelines are based on current knowledge derived from evidence-based medicine coupled with clinical experience of a national working group.

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confidence: 99%

Safety of treatments for inflammatory bowel disease: Clinical practice guidelines of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD)

Biancone

Annese

Ardizzone

et al. 2017

Digestive and Liver Disease

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“…While registers grouping patients across all indications and all TNF inhibitors did not identify an overall increase in cancer risk among IMID patients [83][84][85], with the exception on skin cancers in IBD in the American Register [86]. Data suggests an overall increased risk of cancer when thiopurines based immunomodulatory drugs are used in IBD [85], as well as an increased risk of non-melanoma skin cancer when phototherapy was used in psoriasis patients [87].…”

Section: Malignanciesmentioning

confidence: 97%

Safety evaluation of adalimumab in immune-mediated inflammatory disorders: a rheumatological point of view

Duquenne

Gul

Emery

2018

Expert Opinion on Drug Safety

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Immune-Mediated Inflammatory Disorders (IMIDs) are systemic conditions which arise secondary to complex immune mechanism defects and can affect many organs. While previous therapies based on steroids and immunosuppressive agents had a poor risk/benefit balance TNF such as adalimumab have revolutionised the course of many diseases and patient outcomes. However, concerns were raised regarding the increased risk of infectious diseases and neoplasia due to potential prospective loss of immune control. This is especially true when considering that IMIDs concerns elderly/frail populations, with multiple co-morbidities, organ damage and often long-term steroid therapy. Now prescribed for more than 15 years for a diverse range of indications, long-term data highlighting the efficacy and safety are available and led to recommendations for the daily practice that will be discussed. The efficacy of adalimumab changed the therapeutic paradigm of many diseases. Its tolerance is good and it is the most widely prescribed therapy in many IMIDs. It is now the standard of care arm in head to head trials. In the long term, adalimumab dominant role might be weakened by more targeted therapies but its varied indications among IMIDs should secure its position as an important tool in our practice for years to come.

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“…Clinically, the TNF-α neutralizing antibody infliximab (a chimeric mouse-anti human IgG1) was shown to downregulate the production of other pro-inflammatory cytokines (IL-6 for days 1-28 compared to placebo control), reduce both leucocyte trafficking and tissue destruction, and to lead to both hematological normalization and normalized T cell responses [218]. However, this clinical efficacy is paralleled by frequently observed side-effects such as increased frequencies of infections [207,219,220] and non-melanoma skin cancers [221][222][223][224][225], but not other types of cancer [223,[226][227][228][229].…”

Section: Tnf-α Inhibitorsmentioning

confidence: 99%

Update on the Pathomechanism, Diagnosis, and Treatment Options for Rheumatoid Arthritis

Lin

Anzaghe

Schülke

2020

Cells

554

376

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Rheumatoid arthritis (RA) is an autoimmune disease that involves multiple joints bilaterally. It is characterized by an inflammation of the tendon (tenosynovitis) resulting in both cartilage destruction and bone erosion. While until the 1990s RA frequently resulted in disability, inability to work, and increased mortality, newer treatment options have made RA a manageable disease. Here, great progress has been made in the development of disease-modifying anti-rheumatic drugs (DMARDs) which target inflammation and thereby prevent further joint damage. The available DMARDs are subdivided into (1) conventional synthetic DMARDs (methotrexate, hydrochloroquine, and sulfadiazine), (2) targeted synthetic DMARDs (pan-JAK- and JAK1/2-inhibitors), and (3) biologic DMARDs (tumor necrosis factor (TNF)-α inhibitors, TNF-receptor (R) inhibitors, IL-6 inhibitors, IL-6R inhibitors, B cell depleting antibodies, and inhibitors of co-stimulatory molecules). While DMARDs have repeatedly demonstrated the potential to greatly improve disease symptoms and prevent disease progression in RA patients, they are associated with considerable side-effects and high financial costs. This review summarizes our current understanding of the underlying pathomechanism, diagnosis of RA, as well as the mode of action, clinical benefits, and side-effects of the currently available DMARDs.

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Melanoma and non-Melanoma Skin Cancer in Inflammatory Bowel Disease Patients following Tumor Necrosis Factor-α Inhibitor Monotherapy and in Combination with Thiopurines: Analysis of the Food and Drug Administration Adverse Event Reporting System

Abstract: TNF-α inhibitor monotherapy or use with concomitant thiopurines in patients with IBD is associated with higher odds of developing MSC and NMSC.

Cited by 54 publications

References 31 publications

Safety of treatments for inflammatory bowel disease: Clinical practice guidelines of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD)

Safety of treatments for inflammatory bowel disease: Clinical practice guidelines of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD)

Safety evaluation of adalimumab in immune-mediated inflammatory disorders: a rheumatological point of view

Update on the Pathomechanism, Diagnosis, and Treatment Options for Rheumatoid Arthritis

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