Session Information
Session Title: Epidemiology and Public Health I: Drug and Vaccine Safety
Session Type: Abstract Submissions (ACR)
Background/Purpose
Adalimumab is a fully human monoclonal antibody to tumor necrosis factor alpha and is approved for several indications including rheumatoid arthritis (RA).
Methods
The OTIS Collaborative Research Group conducted a prospective cohort study in the U.S. and Canada between 2004 and 2013 comparing pregnancy outcomes in women with RA treated with adalimumab for some period of the first trimester to women with RA not treated with any adalimumab in pregnancy. No women in either group were also treated with methotrexate, but women may have been treated with another DMARD or steroid. An additional comparison group included women without any autoimmune disease. All three groups were recruited prior to 19 completed weeks’ gestation and followed by extensive telephone interviews throughout pregnancy and after birth. Medical records were reviewed, and a subset of live born infants received dysmorphological examination by a study physician (blinded to the mother’s status). Outcomes were compared using logistic regression techniques and survival methods as appropriate with adjustment for confounders using propensity scoring if two or more confounders were identified.
Results
Seventy-four women exposed to adalimumab, 80 disease-matched comparison women, and 218 non-diseased women enrolled in the study. All women in the adalimumab-exposed group had at least one dose of the medication in the first trimester; approximately 43% of those women used the medication in all three trimesters. The overall lost-to-follow up rate was 5.9%. Disease severity, as measured by the HAQ at the time of enrollment and at 32 weeks’ gestation, was similar between the two disease-matched groups. The rate of major defects in the exposed, disease-matched, and non-diseased comparison groups was 5.6%, 7.8% and 5.5% respectively. In adjusted analysis, there was no significant difference in the overall rate of major malformations among live births in the adalimumab exposed vs. disease-matched group (adjusted Relative Risk (RR) 1.14, 95% Confidence Interval (CI) 0.26, 4.93). A total of 234 infants (70% of live born infants) received the study-related physical examination. The proportion of children with 3 or more minor malformations in the three groups did not differ, and there was no specific pattern of minor malformations identified. Using Cox Proportional Hazards modeling, the adjusted hazard ratio (HR) for spontaneous abortion was 1.96 (95% CI 0.47, 8.26) comparing the adalimumab vs. disease-matched groups; the rate was elevated in comparison to the non-diseased group (adjusted HR 3.79, 95% CI 1.01, 14.23), although the number of events was small. The rate of preterm delivery did not differ significantly among groups, nor did the proportion of infants who were small for gestational age.
Conclusion
Pregnant women with RA who are treated with adalimumab during the first trimester compared to women with the same underlying condition do not appear to be at increased risk of any of the adverse pregnancy outcomes evaluated. Although the sample size is small, these results provide reassuring data to women with RA who require treatment with adalimumab.
Disclosure:
C. D. Chambers,
AbbVie Inc.,
2,
Amgen,
2,
Apotex,
2,
Barr Laboratories, Inc.,
2,
Bristol-Myers Squibb,
2,
Genentech,
2,
Janssen Pharmaceutica Product, L.P.,
2,
Parr Pharmaceutical,
2,
Pfizer Inc,
2,
Roche Pharmaceuticals,
2,
Sandoz,
2,
Sanofi-Aventis Pharmaceutical,
2,
Teva Pharmaceuticals,
2,
UCB,
2;
D. L. Johnson,
AbbVie Inc.,
2,
Amgen,
2,
Apotex,
2,
Barr Laboratories, Inc.,
2,
Bristol-Myers Squibb,
2,
Genentech,
2,
Janssen Pharmaceutica Product, L.P.,
2,
Parr Pharmaceutical,
2,
Pfizer Inc,
2,
Roche Pharmaceuticals,
2,
Sanofi-Aventis Pharmaceutical,
2,
Sandoz,
2,
Teva Pharmaceuticals,
2,
UCB,
2;
Y. Luo,
AbbVie Inc,
2,
Amgen,
2,
Apotex,
2,
Barr Laboratories, Inc.,
2,
Bristol-Myers Squibb,
2,
Genentech,
2,
Janssen Pharmaceutica Product, L.P.,
2,
Parr Pharmaceutical,
2,
Pfizer Inc,
2,
Roche Pharmaceuticals,
2,
Sandoz,
2,
Sanofi-Aventis Pharmaceutical,
2,
Teva Pharmaceuticals,
2,
UCB,
2;
R. Xu,
AbbVie Inc,
2,
Amgen,
2,
Apotex,
2,
Barr Laboratories, Inc.,
2,
Bristol-Myers Squibb,
2,
Genentech ,
2,
Janssen Pharmaceutica Product, L.P.,
2,
Parr Phamaceutical,
2,
Pfizer Inc,
2,
Roche Pharmaceuticals,
2,
Sandoz,
2,
Sanofi-Aventis Pharmaceutical,
2,
Teva Pharmaceuticals,
2,
UCB,
2;
K. L. Jones,
AbbVie Inc,
2,
Amgen,
2,
Apotex,
2,
Barr Laboratories, Inc.,
2,
Bristol-Myers Squibb,
2,
Genentech ,
2,
Janssen Pharmaceutica Product, L.P.,
2,
Parr Pharmaceutical,
2,
Pfizer Inc,
2,
Roche Pharmaceuticals,
2,
Sandoz,
2,
Sanofi-Aventis Pharmaceutical,
2,
Teva Pharmaceuticals,
2,
UCB,
2.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/pregnancy-outcome-in-women-treated-with-adalimumab-for-the-treatment-of-rheumatoid-arthritis-an-update/