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Adalimumab: Lymphomas

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

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Adalimumab: Lymphomas

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  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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