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Abstract Number: 1644

Enhanced Pharmacovigilance Reporting of Malignancies in Children and Young Adults Taking Etanercept

Michele Hooper1, Deborah Wenkert2, Bojena Bitman3, Virgil C. Dias4, Yessinia Bartley5, Julie Wang6 and Julia R. Gage7, 1Amgen Global Safety, Amgen Inc., Thousand Oaks, CA, 2Inflammation TA, Amgen Inc., Thousand Oaks, CA, 3Amgen, Inc., San Francisco, CA, 4Amgen Inc., Thousand Oaks, CA, 5Assent Consulting, Solana Beach, CA, 6Amgen Inc, One Amgen Center Drive, Thousand Oaks, CA, 7Gage Medical Writing, LLC, Oak Park, CA

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: biologic response modifiers, etanercept, juvenile idiopathic arthritis (JIA), malignancy and pediatric rheumatology

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Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy: Safety I

Session Type: Abstract Submissions (ACR)

Background/Purpose: Recent reports suggest an increased rate of malignancy in children with juvenile idiopathic arthritis (JIA) (Simard, A&R 2010;62:3776; Beukelman A&R 2012;64:1263).  In 2011, the US FDA required TNF-blocker sponsors to initiate a 10-year postmarketing reporting commitment of all malignancies in children and young adults.  We present the results to date for etanercept (ETN).

Methods: We reviewed all malignancies reported in patients ≤ 30 years (yrs) of age from clinical trials (CTs) and ARGUS (postmarketing cases, observational studies).  Cases were included regardless of latency period, time on ETN, lack of tumor histology, reporting source (consumer, investigator, healthcare provider, regulatory agency, literature), or confounding factors.  CT malignancy rates in ETN arms were compared with placebo/comparator arms.  Exposure data used to generate ARGUS reporting rates were determined from the total mg of ETN dispensed from Nov 1998 through 31 Dec 2011 and from US market research-determined age distribution (birth-30 yrs, birth-11 yrs, 12-17 yrs, 18-30 yrs) extrapolated to the global market.  Confidence intervals were not calculated for ARGUS rates as the ETN exposure data are estimates.  Age-specific rates were generated from the Surveillance Epidemiology and End Results (SEER) database v7.0.9.  ARGUS reporting rates and SEER rates for all malignancies and malignancy types with ≥ 5 cases are shown.

Results: In CTs, 1 malignancy each in ETN and placebo/comparator arms has been reported.  ETN exposure was 231,404 patient-years (PY) (24,820 PY in birth-11 yrs; 38,099 PY in 12-17 yrs; 168,485 PY in 18-30 yrs).  Rates observed per 100,000 PY in ARGUS and SEER, respectively for all malignancies were: age birth-30 yrs: 44.5 and 26.4; birth-11 yrs: 24.2 and 15.3; 12-17 yrs: 34.1 and 17.0; and 18-30 yrs: 46.9 and 42.1.  Five or more cases of leukemia, lymphoma, melanoma, thyroid, and cervical cancers were reported.  Rates for melanoma, thyroid, and cervical cancers seemed similar in ARGUS and SEER.  Overall ARGUS leukemia rates seemed similar to SEER except for patients birth-11 yrs (12.1 and 5.4 per 100,000 PY, respectively) based on 3 cases.  There were 23 cases of lymphoma.  ARGUS rates of non-Hodgkin lymphoma seemed similar to SEER.  Rates per 100,000 PY for Hodgkin disease (HD) in ARGUS and SEER were:  birth-30 yrs: 3.9 and 2.2; birth-11 yrs: 12.1 and 0.4; 12-17 yrs 7.9 and 2.1; 18-30 yrs: 1.8 and 4.1.

Conclusion: In the ARGUS database, overall malignancy rates seemed higher than in the general pediatric population (SEER). Stratification by age suggests higher rates for those younger than 18 years old compared to SEER rate, consistent with a report of increased malignancy in all JIA patients (standardized rate = 79.3 per 100,000 PY), and untreated JIA patients (106.5 per 100,000 PY) (Beukelman 2012).  No increased malignancy rate seemed to occur in the young adult age group.  The overall lymphoma reporting rate was not increased; however, there was more HD in younger patients, most with long-standing disease and multiple immunosuppressive exposures.


Disclosure:

M. Hooper,

Amgen Inc.,

3,

Amgen,

1;

D. Wenkert,

Amgen,

1,

Amgen,

3;

B. Bitman,

Amgen,

1,

Amgen,

3;

V. C. Dias,

Amgen,

1,

Amgen,

3;

Y. Bartley,

Amgen,

9;

J. Wang,

Amgen,

1,

Amgen,

3;

J. R. Gage,

Amgen,

5.

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