Transcript Rheumatoid Arthritis and Pregnancy Study Update

OTIS Autoimmune Diseases
in Pregnancy Study
OTIS ANNUAL RESEARCH MEETING
JUNE 2010
Background
 Project began in 2000 with one sponsor, Sanofi-
Aventis, to prospectively follow women exposed to
leflunomide for the treatment of rheumatoid arthritis
 The Project is currently funded by eight
pharmaceutical companies
 Prospective, observational cohort study
 Coordinating center is at the University of California,
San Diego
Purpose
 The purpose of the research study is to evaluate the
risks to the developing fetus from autoimmune
diseases and the safety of medications used to treat
these diseases during pregnancy.
Study Participation
 Self-enrollment
 3-4 phone interviews (intake, 20wk, 32wk, outcome)
 Medical records pertaining to the pregnancy and
outcome of the pregnancy
 Free non-invasive pediatric exam
Total Enrollment to Date
Total as of
June 7, 2010
June 2009 to
May 2010
Enrolled
1325
278
Outcome
1161
252
Live birth
1022
225
Dysmorphological
Exam
652
134
AI Cohort Study Totals
Group
Total Enrolled
Recruitment
Goal
1
100
Adalimumab (Humira)
149
120
Etanercept (Enbrel)
288
300
Leflunomide
Methotrexate
Diseased Controls
72
9
336
200
760
Non-Diseased Controls
Total Cohort
251
1106
460
1940
Abatacept (Orencia)
Recruitment
Source
Health-care Professional
No. Enrolled
N (%)
552 (41.7)
TIS
366 (27.6)
Other
263 (19.8)
Internet
144 (10.9)
Marketing Plans 2010
 Scientific Meetings:
 16 trade shows
 Quarterly Mailings and Email Updates
 Journal Advertisements
 Internet Advertisements
Who Should be Referred?
Groups
Criteria
Abatacept (Orencia)
Any pregnancy related call regarding Abatacept
(Orencia)
Adalimumab (Humira)
Any pregnancy related call regarding
Adalimumab (Humira)
Etanercept (Enbrel)
Exposed to Etanercept anytime during the
current pregnancy (post LMP)
Leflunomide
Pregnant women who have taken Leflunomide
within the past two years
Methotrexate
Pregnant women with exposure to Methotrexate
for the treatment of RA
Diseased Controls
Pregnant women with RA, AS, PsA, PsO, and
Crohn’s Disease
Non-Diseased Controls
Pregnant women who are < 20 weeks gestation
How to Refer?
 Toll-free number at 877-311-8972 to refer patient
OR provide the patient our toll-free number
 Contact via email at [email protected]
 Fax a referral sheet to OTIS which is found on our
website at www.otispregnancy.org