Pregnancy Outcome in Women Treated With Adalimumab for the Treatment of Rheumatoid Arthritis: An Update on the OTIS Autoimmune Diseases in Pregnancy Project
Bibliographic record
Abstract
Introduction: To investigate pregnancy outcomes in women who received adalimumab (ADA) to treat rheumatoid arthritis (RA) during pregnancy. Methods: The OTIS collaborative research group conducted a prospective cohort study in the U.S. and Canada, 2004-2013, comparing pregnancy outcomes in women with RA treated with ADA to women with RA not treated with ADA. Participants may have been treated with another disease-modifying antirheumatic drug or steroid but not methotrexate. An additional comparison group included women without any autoimmune disease. Participants enrolled <19 weeks gestation and were followed by telephone interviews and medical record review. A subset of infants received a dysmorphological examination by a study physician. Outcomes were compared using regression or survival methods with adjustment for confounders. Results: Seventy-four ADA-exposed, 80 disease-matched and 218 non-diseased women were enrolled. Women in the ADA group had at least 1 dose in the first trimester; ˜43% used ADA in all trimesters. Disease severity was similar between the two diseased groups. The rates of major defects in the exposed, disease-matched, and non-diseased comparison groups were 5.6%, 7.8%, and 5.5% respectively. There was no significant difference in the rate of major malformations among live births in the ADA vs. disease-matched group (adjusted relative risk 1.14, 95% confidence interval [CI] 0.26, 4.93). Among those who received the dysmorphological examination, there were no differences in number with ≥3 minor malformations, and no specific pattern was identified. There was no significant difference in the risk of spontaneous abortion in the ADA vs. disease-matched groups (adjusted hazard ratio 1.96, 95% CI 0.47, 8.26); the rate was elevated in comparison to the non-diseased group (adjusted hazard ratio 3.79, 95% CI 1.01, 14.23), although the number of events was small. Rates of preterm delivery and small for gestational age were similar across groups. Conclusion: Pregnant women with RA treated with ADA in the first trimester compared to women with the same condition do not appear to be at increased risk of the adverse pregnancy outcomes evaluated. Although the sample size is small, these results are reassuring to pregnant women with RA who require treatment with ADA. AbbVie provided funding for this study and participated in the study design. AbbVie did not participate in study conduct, analysis, and interpretation of data. AbbVie had the opportunity to review and comment on the publication. All authors independently analyzed and interpreted the data, and authors maintained full control over the content of the publication. Disclosure - Research Grant Funding: Bristol Myers Squibb, La Roche, Genentech, CSL, Novartis, Amgen, Celgene, GSK, UCB, Eli, Protein Sciences, Abbott, TIS, Norvartis, Janseen, Sanofi Aventis, Pfizer. This research was supported by an industry grant from This research was supported by a grant from AbbVie Inc.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.006 | 0.009 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.004 | 0.004 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".