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Evaluating Lymphoma Risk Associated with TNF Blockers in RA Treatment: Insights from 2003

This presentation discusses the occurrence of lymphomas in patients treated with TNF blockers, specifically focusing on Adalimumab, Etanercept, and Infliximab. It presents data from controlled trials and overall databases, highlighting case incidences and standardized incidence ratios (SIRs) for each treatment. The findings suggest an association between these medications and an increased lymphoma risk, particularly in RA patients. Key recommendations for risk management and data collection practices are outlined to optimize patient safety while maximizing treatment benefits.

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Evaluating Lymphoma Risk Associated with TNF Blockers in RA Treatment: Insights from 2003

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Presentation Transcript

  1. Presented at the Arthritis Advisory Committee meeting on March 4, 2003 by Jeffrey N. Siegel, M.D.

  2. Adalimumab: Lymphomas • Controlled portions of controlled trials: • Adalimumab: 2 cases among 1380 patients, 0.6 yrs mean exposure • Placebo: 0 cases among 690 patients, 0.5 yrs mean exposure • Overall database: 10 cases among 2400 patients, 2.4 yrs median exposure, SIR 5.42 (2.6, 10.0)

  3. Etanercept: Lymphomas • Controlled portions of controlled trials: • Etanercept: 1 case among 2502 patients, 0.5 yrs mean exposure • Placebo: 0 cases among 921 patients, 0.5 yrs mean exposure • Overall database: 6 cases among 3389 patients, 2.2 yrs mean exposure, SIR 2.31 (0.85, 5.03)

  4. Infliximab: Lymphomas • Controlled portions of controlled trials: • Infliximab: 3 cases among 2421 patients, 1.0 yrs mean exposure • Placebo: 0 cases among 489 patients, 0.9 yrs mean exposure • Overall database: 6 cases among 2421 patients, 1.7 yrs mean exposure, SIR 6.98 (2.56, 15.19)

  5. Concluding Remarks: Lymphomas • Newer data show occurrence of lymphomas with each of the approved agents: • In controlled trials, 1-3 cases with study drugs vs. 0 with placebo • Controlled plus non-controlled extension trials showed higher rate than in general US population • Additional cases in post-marketing experience • Higher reported rates in RA patients complicates analysis

  6. CHF • Deleterious effects of infliximab in CHF patients • Concerning trends in CHF patients receiving etanercept • Adalimumab – not known

  7. Conclusions • Approved TNF blockers associated with high ACR response rates in RA, beneficial effects in progression of structural damage • For infliximab, demonstrated improvement in HAQ in long-term study • A number of serious, but uncommon, adverse reactions also associated with their use • For some adverse events, risks can be reduced with appropriate screening

  8. Risk Management • Important to: • Maximize benefit • Minimize risk • For identified risks of TNF blockers: • Collect data to accurately assess risk • Minimize risks where appropriate by patient selection and screening • Risk communication

  9. Agency Welcomes Discussion of: • For lymphoma • Confounding factors in assessing causal relationships • Likelihood of causal relationship between lymphomas & TNF blockers • How to collect data that would help assess causal associations • Appropriate language for labels to communicate available information • For CHF • Approaches to risk management

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