Surveillance, Epidemiology, and End Results (SEER) Database. An increased rate oflymphoma up to several-fold has been reported in the RA patient population, and may be further increased in patientswith more severe disease activity.
Among 4410 adult PsO patients treated with etanercept in clinical trials up to 36 months, representing approximately4278 patient-years of therapy, the observed rate of lymphoma was 0.05 cases per 100 patient-years, which iscomparable to the rate in the general population. No cases were observed in etanercept- or placebo-treated patients
during the controlled portions of these trials.
Leukemia
Cases of acute and chronic leukemia have been reported in association with postmarketing TNF blocker use inrheumatoid arthritis and other indications. Even in the absence of TNF blocker therapy, patients with rheumatoidarthritis may be at higher risk (approximately 2-fold) than the general population for the development of leukemia.
During the controlled portions of etanercept trials, 2 cases of leukemia were observed among 5445 (0.06 cases per 100patient-years) etanercept-treated patients versus 0 among 2890 (0%) control patients (duration of controlled treatmentranged from 3 to 48 months).
Among 15,401 patients treated with etanercept in controlled and open portions of clinical trials representing
approximately 23,325 patient-years of therapy, the observed rate of leukemia was 0.03 cases per 100 patient-years.
Other Malignancies
Information is available from 10,953 adult patients with 17,123 patient-years and 696 pediatric patients with 1282patient-years of experience across 45 etanercept clinical studies.
For malignancies other than lymphoma and non-melanoma skin cancer, there was no difference in exposure- adjustedrates between the etanercept and control arms in the controlled portions of clinical studies for all indications. Analysis of the malignancy rate in combined controlled and uncontrolled portions of studies has demonstrated that types andrates are similar to what is expected in the general U.S. population based on the SEER database and suggests noincrease in rates over time. Whether treatment with etanercept products might influence the development and courseof malignancies in adults is unknown.
Melanoma and Non-Melanoma Skin Cancer (NMSC)Melanoma and non-melanoma skin cancer has been reported in patients treated with TNF antagonists includingetanercept products.
Among 15,401 patients treated with etanercept in controlled and open portions of clinical trials representingapproximately 23,325 patient-years of therapy, the observed rate of melanoma was 0.043 cases per 100 patient-years.
Among 3306 adult rheumatology (RA, PsA, AS) patients treated with etanercept in controlled clinical trials representing approximately 2669 patient-years of therapy, the observed rate of NMSC was 0.41 cases per 100 patientyearsvs 0.37 cases per 100 patient-years among 1521 control-treated patients representing 1077 patient-years. Among1245 adult PsO patients treated with etanercept in controlled clinical trials, representing approximately 283 patientyearsof therapy, the observed rate of NMSC was 3.54 cases per 100 patient-years vs 1.28 cases per 100 patient-yearsamong 720 control-treated patients representing 156 patient-years.
Postmarketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with etanerceptproducts.
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