A pioneering gastroenterologist transforming our understanding of medication safety during pregnancy for women with inflammatory bowel disease.
In the specialized world of inflammatory bowel disease (IBD), few names command as much respect as Dr. Sonia Friedman, a gastroenterologist at Brigham and Women's Hospital whose groundbreaking work has transformed our understanding of medication safety during pregnancy. As both a physician and published poet, Dr. Friedman brings a unique perspective to the complex intersection of chronic illness and reproductive health, helping thousands of women with Crohn's disease and ulcerative colitis navigate the challenging journey of pregnancy without compromising their disease management. Her pioneering research, particularly on the safety of IBD medications before and during pregnancy, has provided evidence-based guidance where previously there was only uncertainty and fear, making her one of the most influential voices in modern gastroenterology. 1
Dr. Friedman's path to medical excellence began with a childhood immersed in both science and the humanities—a dualism that would come to define her approach to patient care. She grew up in Lawrenceville, New Jersey, with a chemical engineer father who fostered her early interest in science and a mother who was a Holocaust studies professor and feminist who "pushed me to excel academically" 2 . This balanced upbringing produced not only a future physician but also an accomplished violinist who once served as concertmaster of her regional youth symphony.
Her time at Stanford University proved formative, where she conducted neuroscience research in Dr. Carla Jo Shatz's laboratory, investigating glial cells' role in optic nerve development 2 . This early research experience resulted in a first-author publication and presentation at a national neuroscience meeting—impressive accomplishments for an undergraduate student.
However, Friedman eventually realized that "people's stories interested me more than microscopes," prompting her to pursue a straight medical degree at Yale rather than an MD-PhD program 2 .
During her internal medicine residency at the Hospital of the University of Pennsylvania, Friedman found herself drawn to the complex challenges of IBD patients 2 . This was the era before biologic therapies, when treatment options were limited to prednisone, 6-mercaptopurine, sulfasalazine/Asacol, or surgery 2 .
Trained under legendary figures including Dr. Daniel Present, Dr. Henry Janowitz, and actually saw patients while sitting at Dr. Burrill Crohn's massive oak desk 2 .
"I took call every other night for a year and half"—provided Friedman with unparalleled training in both the technical and humanistic aspects of IBD care 2 .
After completing her training, Dr. Friedman noticed a critical gap in IBD care that was affecting a substantial portion of her patients. With IBD incidence peaking in the third decade of life—coinciding with prime reproductive years—many of her female patients faced agonizing choices about starting families while managing their chronic condition . As she recounted, "Many of my IBD patients were young and concerned about the safety of drugs and disease activity during pregnancy" 2 .
At the time, limited evidence existed to guide medication decisions during pregnancy, leading to inconsistent recommendations from physicians and unnecessary anxiety for patients. Some women discontinued effective therapies out of fear of harming their babies, risking disease flares that themselves posed dangers to pregnancy outcomes.
Dr. Friedman's pregnancy safety research took a transformative turn when she was asked to write an editorial on a paper by Dr. Bente Mertz Nørgård, a clinical epidemiologist from Denmark specializing in IBD medication safety 2 . Friedman's insightful commentary on Nørgård's work—which utilized Denmark's comprehensive national registry of all citizens—initiated what would become one of the most productive collaborations of her career 2 .
This partnership combined Friedman's clinical expertise with Nørgård's epidemiological prowess, creating a research team uniquely positioned to address complex questions about medication safety in pregnancy. As Friedman described, "Whereas I can provide a foundation for what is clinically relevant, Dr. Nørgård understands what is statistically realistic" 2 .
One of the most significant contributions to emerge from this area of research—exemplifying the work that builds upon Dr. Friedman's foundational studies—is a 2025 meta-analysis comparing the safety of ustekinumab versus anti-TNF therapy during pregnancy in patients with IBD . As biologic medications have become increasingly essential for controlling IBD activity during pregnancy, establishing their safety profiles has become a critical research priority.
This comprehensive analysis systematically reviewed data from four separate studies encompassing 3,308 pregnancies in women with IBD (592 exposed to ustekinumab and 2,716 exposed to anti-TNF therapy) . The researchers employed rigorous statistical methods to compare pregnancy outcomes between the two treatment groups, focusing on clinically significant endpoints including live birth rates, spontaneous abortion, preterm delivery, low birth weight, and cesarean section rates .
| Study | Publication Year | Ustekinumab-Exposed Pregnancies | Anti-TNF-Exposed Pregnancies | Patient Population |
|---|---|---|---|---|
| Avni-Biron et al. | 2022 | 27 | 52 | Primarily Crohn's disease |
| Mitrova et al. | 2022 | 54 | 90 | Primarily Crohn's disease |
| Chugh et al. | 2024 | 47 | 718 | Primarily Crohn's disease |
| Meyer et al. | 2025 | 464 | 1,856 | Primarily Crohn's disease |
The meta-analysis revealed no significant differences in major pregnancy outcomes between the ustekinumab and anti-TNF groups . Specifically, the live birth rates were nearly identical—67.2% for ustekinumab versus 67.7% for anti-TNF therapy—with no statistically significant differences in adverse pregnancy outcomes . These findings were particularly noteworthy given that the majority of patients (88.2%) had Crohn's disease with substantial disease duration ranging from 6.5 to 14 years, representing a population with significant disease burden .
| Outcome Measure | Ustekinumab Group | Anti-TNF Group | Odds Ratio | Statistical Significance |
|---|---|---|---|---|
| Live Birth Rate | 67.2% | 67.7% | 0.73 (0.39-1.37) | Not significant |
| Spontaneous Abortion | 5.9% | 4.2% | 1.51 (0.74-3.36) | Not significant |
| Preterm Delivery | 6.6% | 7.4% | 0.50 (0.15-1.61) | Not significant |
| Low Birth Weight | 4.6% | 7.1% | 0.68 (0.23-1.98) | Not significant |
| Cesarean Section | 30.0% | 30.1% | 1.11 (0.85-1.45) | Not significant |
This research represents a crucial advancement in the evidence-based management of IBD during pregnancy, providing much-needed data on newer biologic medications like ustekinumab. For clinicians and patients alike, these findings offer reassurance that effective disease control can be maintained during pregnancy without increasing risks to the fetus—a principle that Dr. Friedman has championed throughout her career.
The groundbreaking work pioneered by Dr. Friedman and her colleagues relies on several key "research reagents"—methodological approaches and resources that enable robust investigation of medication safety in pregnancy. These tools have transformed our ability to generate reliable evidence in a field where randomized controlled trials are often ethically challenging.
Comprehensive databases linking medication exposure to health outcomes across entire populations.
Example: Collaboration with Dr. Nørgård utilizing Danish national registry data 2
Systematic follow-up of pregnant patients from conception to postpartum period.
Example: Inclusion of three prospective observational studies in the ustekinumab meta-analysis
Standardized instruments to measure patient-reported outcomes and experiences.
Example: Development of surveys measuring self-efficacy, doctors' messages, and patient fears about colon cancer 2
Statistical methods for combining data from multiple studies to enhance statistical power.
Example: Pooled analysis of 3,308 pregnancies to compare ustekinumab and anti-TNF safety
Dr. Sonia Friedman's career exemplifies the powerful synergy between clinical expertise and rigorous research, demonstrating how physician-scientists can directly address the most pressing concerns of their patients. Her work has fundamentally transformed the landscape of IBD management during pregnancy, replacing uncertainty with evidence-based guidance that has improved countless lives.
Beyond the specific contributions to medication safety, Dr. Friedman's integrated approach—honed through her unusual combination of scientific rigor and poetic sensibility—offers a model for how medicine can balance technical excellence with humanistic care.
As IBD treatment continues to evolve with new medications and approaches, the methodological foundation established by Dr. Friedman and her collaborators will remain essential for evaluating the safety and efficacy of these innovations in vulnerable populations.
Her career stands as a testament to the power of focusing on the patient behind the disease, and the progress possible when we listen carefully to the concerns of those we seek to help. As she continues to investigate men's reproductive health in IBD—"an understudied topic" 2 —her work continues to expand our understanding of how chronic inflammation and its treatment interact with human reproduction at all stages of life.