Diagnosis of melanoma under concomitant natalizumab therapy

Vavricka, Bettina M. Prinz; Baumberger, Peter; Russmann, Stefan; Kullak‐Ublick, Gerd A.

doi:10.1177/1352458510389629

Cited by 25 publications

(13 citation statements)

References 6 publications

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“…However, to date, no single study has assembled data from all RCTs to assess the risk of opportunistic infection or malignancy. Due to their rarity in clinical trials, until now estimates of the risk of these events occurring with anti‐integrin antibodies has relied on case reports and case series, mainly from the neurology literature . Our study has shown that the risk of such an event occurring in a treated patient is between 0.2% and 1.1%, and this should be balanced against the efficacy of these agents for patients with IBD, as well as the risk that patients are prepared to accept in exchange for remission of their symptoms, which may be quite different to that anticipated by clinicians .…”

Section: Discussionmentioning

confidence: 90%

Systematic review and meta‐analysis: opportunistic infections and malignancies during treatment with anti‐integrin antibodies in inflammatory bowel disease

Luthra

Peyrin–Biroulet

Ford

2015

Aliment Pharmacol Ther

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Summary Background Anti‐integrin antibodies are effective therapies for Crohn's disease (CD) and ulcerative colitis (UC). However, these drugs carry theoretical risks of opportunistic infection and malignancy. Aim To pool data from all placebo‐controlled studies, to estimate risk of opportunistic infection or malignancy with anti‐integrin antibodies. Methods MEDLINE, EMBASE and the Cochrane central register of controlled trials were searched (up to December 2014). Randomised placebo‐controlled trials of anti‐integrin antibodies in adults with active or quiescent CD or UC were eligible. Dichotomous data were pooled to obtain a relative risk (RR) of opportunistic infection or malignancy, with 95% confidence intervals (CIs). Results The search strategy identified 1579 citations, 12 of which were eligible (four trials of natalizumab, six of vedolizumab and two of etrolizumab). The RR of developing an opportunistic infection was not significantly higher with non‐gut specific (2.34; 95% CI 0.05–108.72) or gut specific anti‐integrin antibodies (1.55; 95% CI 0.16–14.83). The RR was generally higher in trials of non‐gut specific anti‐integrin antibodies with duration of therapy ≥52 weeks (RR = 15.00; 95% CI 0.86–261), but remained non‐significant. The RR of malignancy was not elevated with non‐gut specific (1.57; 95% CI 0.19–12.74) or gut specific anti‐integrin antibodies (0.78; 95% CI 0.15–4.02). Conclusions Absolute numbers of opportunistic infections were higher with anti‐integrin antibodies, but this difference is not statistically significant. There was no increased risk of malignancy detected. Long‐term data in large prospective cohorts are needed to further assess this issue.

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Section: Discussionmentioning

confidence: 90%

Systematic review and meta‐analysis: opportunistic infections and malignancies during treatment with anti‐integrin antibodies in inflammatory bowel disease

Luthra

Peyrin–Biroulet

Ford

2015

Aliment Pharmacol Ther

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“…Six cases were reported, five from the natalizumab group (three breast cancer, one stage 0 cervical cancer, one metastatic melanoma) and one from the placebo group (basal cell carcinoma) [154]. Case reports have described melanoma and peripheral T-cell lymphoma in patients receiving natalizumab, although a causal association has not been established [155,156]. …”

Section: Anti-integrin Therapymentioning

confidence: 99%

Adverse events in IBD: to stop or continue immune suppressant and biologic treatment

McLean

Cross²

2014

Expert Review of Gastroenterology & Hepatology

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Crohn’s disease and ulcerative colitis affect an increasing number of patients. A variety of medical options exist for the treatment of these diseases including immune suppressants and biologic therapies. Unfortunately, these agents are associated with adverse events ranging from mild nuisance symptoms to potentially life-threatening complications including infections and malignancies. This review discusses adverse events associated with azathioprine, mercaptopurine, and methotrexate as well as anti-TNF-α and anti-integrin antibodies. In addition, adverse events associated with combination therapy are discussed as are clinical scenarios in which it may be reasonable to discontinue or de-escalate drug therapy. It is the responsibility of the treating gastroenterologist to effectively communicate the benefits and risks of therapy with patients; this review offers strategies that may assist providers in communicating risk with patients in addition to offering our perspective on whether modification or cessation of therapy can be considered.

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“…Case information for seven published cases was reviewed (Table 2) 2, 18, 19, 20, 21, 22, 23. Among the seven cases, six patients were female.…”

Section: Resultsmentioning

confidence: 99%

Melanoma complicating treatment with natalizumab for multiple sclerosis: A report from the Southern Network on Adverse Reactions (SONAR)

et al. 2017

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A 43‐year‐old female with multiple sclerosis developed urethral melanoma. The only potential risk factor was treatment with natalizumab, a humanized monoclonal antibody against α4 integrins. To investigate the risk‐exposure relationship, we reviewed this case, all other published cases, and cases of natalizumab‐associated melanoma reported to regulatory agencies. Data sources included the Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) (2004–2014), a FDA Advisory Committee Meeting Report, and peer‐reviewed publications. In the United States, the manufacturer maintains an FDA‐mandated Tysabri Safety Surveillance Program (part of the Tysabri Outcomes Unified Commitment to Health (TOUCH)) of natalizumab‐treated patients. We statistically compared reporting completeness for natalizumab‐associated melanoma cases in FAERs for which information was obtained entirely from the TOUCH program versus cases where FAERS information was supplemented by TOUCH program information. FAERS included 137 natalizumab‐associated melanoma reports in patients with multiple sclerosis. Median age at melanoma diagnosis was 45 years (range: 21–74 years). Changes in preexisting nevi occurred in 16%, history of cutaneous nevi occurred in 22%, diagnosis within 2 years of beginning natalizumab occurred in 34%, and 74% had primary surgical treatment. Among seven natalizumab‐treated MS patients who developed biopsy‐confirmed melanoma on treatment and reported in the literature, median age at diagnosis was 41 years (range: 38–48 years); and the melanoma diagnosis occurred following a median of 12 natalizumab doses (range: 1–77 doses). A history of mole or nevi was noted in four patients and a history of prior melanoma was noted in one patient. Completeness scores for reports were significantly lower for FAERS cases reported from the TOUCH program versus FAERS cases supplemented by TOUCH information (median score of 2 vs. 4 items out of 8‐possible items, P < 0.0007). Clinicians should monitor existing nevi and maintain suspicion for melanoma developing in natalizumab‐treated patients. The TOUCH Safety Surveillance Program, currently focused on progressive multifocal leukoencephalopathy, should be expanded to include information on other serious complications including malignancies, particularly if they are immunologic in nature.

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Diagnosis of melanoma under concomitant natalizumab therapy

Cited by 25 publications

References 6 publications

Systematic review and meta‐analysis: opportunistic infections and malignancies during treatment with anti‐integrin antibodies in inflammatory bowel disease

Systematic review and meta‐analysis: opportunistic infections and malignancies during treatment with anti‐integrin antibodies in inflammatory bowel disease

Adverse events in IBD: to stop or continue immune suppressant and biologic treatment

Melanoma complicating treatment with natalizumab for multiple sclerosis: A report from the Southern Network on Adverse Reactions (SONAR)

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