Recent Publications by CFE Educators
Recent Published articles, books, and other scholarship by Academy members, CFE Education Scientists, and CFE Faculty.
POS0788 BIMEKIZUMAB DEMONSTRATED SUSTAINED EFFICACY AND SAFETY ACROSS THE FULL SPECTRUM OF AXIAL SPONDYLOARTHRITIS: 3-YEAR RESULTS FROM TWO PHASE 3 STUDIES AND THEIR OPEN-LABEL EXTENSION.
2025
Authors: X. Baraliakos, A. Deodhar, D. van der Heijde, F. van den Bosch, M. Magrey, W.P. Maksymowych, T. Tomita, H. Xu, D. Voiniciuc, C. Prajapati, M. Manente, A. Marten, L.S. Gensler
POS0773 LOW UVEITIS RATES IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS OR PSORIATIC ARTHRITIS TREATED WITH BIMEKIZUMAB: LONG-TERM RESULTS FROM PHASE 2B/3 TRIALS.
2025
Authors: I. van der Horst-Bruinsma, M. Brown, F. van Gaalen, N. Haroon, L.S. Gensler, A. Marten, M. Manente, G. Stojan, T. Vaux, K. White, A. Deodhar, M. Rudwaleit
POS0118 ASAS RECOMMENDATIONS ON REPORTING OUTCOMES OF CORE OUTCOME SET INSTRUMENTS IN AXIAL SPONDYLOARTHRITIS CLINICAL TRIALS.
2025
Authors: F. van Gaalen, V. Navarro-Compán, X. Baraliakos, F. van den Bosch, L.S. Gensler, I. Hmamouchi, R. Landewé, P. Machado, H. Marzo-Ortega, V. Rios Rodriguez, D. Poddubnyy, S. Ramiro, D. van der Heijde
Long-term safety and efficacy of bimekizumab in axial spondyloarthritis: 2-year results from two phase 3 studies.
2025
Authors: Baraliakos X, Deodhar A, van der Heijde D, Van den Bosch F, Magrey M, Maksymowych WP, Tomita T, Xu H, Massow U, Vaux T, Prajapati C, Manente M, Marten A, Gensler LS
OBJECTIVES
Bimekizumab, a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A, previously demonstrated efficacy and was well tolerated to 1 year in patients with non-radiographic (nr-) and radiographic (r-) axial spondyloarthritis (axSpA). Here, we report bimekizumab safety and efficacy to 2 years.
METHODS
Patients completing week 52 in the phase 3 studies BE MOBILE 1 (nr-axSpA; NCT03928704) and 2 (r-axSpA; NCT03928743) were eligible for an ongoing open-label extension (OLE; NCT04436640). All OLE patients received subcutaneous bimekizumab 160 mg every 4 weeks. Safety outcomes for patients who received ≥1 bimekizumab dose, and efficacy outcomes for all randomized patients, are reported to week 104.
RESULTS
In the OLE (weeks 52 - 104), 70.8% (367/518) of patients reported ≥1 treatment-emergent adverse event (TEAE). Most frequent TEAEs [exposure-adjusted incidence rate per 100 patient-years (EAIR/100PY)] were SARS-CoV-2 (COVID-19) infection (25.2), nasopharyngitis (11.0) and oral candidiasis (5.4). Fungal infection EAIR/100PY was 11.8 (majority Candida infections: 6.8; most mild/moderate, none serious/systemic). Inflammatory bowel disease and uveitis rates were low; no major adverse cardiovascular events or deaths occurred. TEAE incidence rate was generally similar across weeks 0 - 52 and 52 - 104.At week 104, >50% of randomized patients (N = 586) achieved Assessment of SpondyloArthritis international Society 40% response (ASAS40); ∼60% achieved Axial Spondyloarthritis Disease Activity Score (ASDAS) low disease activity (2.1) and >30% achieved ASDAS inactive disease (1.3). Bimekizumab demonstrated sustained suppression of MRI inflammation at week 104, with >57% of patients achieving MRI remission.
CONCLUSIONS
The safety profile of bimekizumab remained consistent with prior reports, with no new safety signals identified. 1-year efficacy was sustained to 2 years across patients with nr-axSpA and r-axSpA.
View on PubMedSerum estradiol (sE2) levels in premenopausal (PreM) women receiving neoadjuvant ovarian function suppression (OFS) with the oral SERD amcenestrant, alone, or in combination with letrozole or abemaciclib in the I-SPY2 Endocrine Optimization Pilot (EOP).
2025
Authors: Jo Chien, Peter Norwood, Rita Mukhtar, Karthik Giridhar, Matthew P. Goetz, Christos Vaklavas, Anthony D. Elias, Mei Wei, Hope S. Rugo, Nan Chen, Alexander D. Borowsky, Lamorna Brown Swigart, Rebecca Arielle Shatsky, Laura Ann Huppert, Michelle E. Melisko, Laura Esserman
Reframing hormone-positive DCIS management: Effects of adjuvant therapies and surgical extent on any invasive recurrence.
2025
Authors: Thomas O'Keefe, Christina Yau, Sophie Lin, Nicolas Prionas, Gillian L. Hirst, Rita Mukhtar, Anne M. Wallace, Michael Alvarado, Laura Esserman
Patient experiences of diagnosis and treatment of invasive lobular carcinoma: A qualitative study from a prospective registry.
2025
Authors: Astrid Quirarte, Anna Lannhi Vertido, Sophia Zamudio-Haas, Jo Chien, Rita Mukhtar
I-SPY2 endocrine optimization pilot (EOP): Neoadjuvant lasofoxifene (Laso) in molecularly selected patients with hormone receptor positive (HR+)/HER2 negative (HER2-) stage 2/3 breast cancer (BC).
2025
Authors: Mei Wei, Anthony D. Elias, Karthik Giridhar, Matthew P. Goetz, Rita Mukhtar, Christos Vaklavas, Laura van t Veer, Silver Alkhafaji, Gillian L. Hirst, Hope S. Rugo, Nan Chen, W. Fraser Fraser Symmans, Alexander D. Borowsky, Lamorna Brown Swigart, Natsuko Onishi, Douglas Yee, Nola Hylton, Laura Esserman, Jo Chien
Circulating tumor DNA (ctDNA) in patients with stage 2/3 HR+HER2-negative breast cancer (BC) treated with neoadjuvant endocrine therapy (NET) in the I-SPY2 endocrine optimization pilot (EOP) trial.
2025
Authors: Silver Alkhafaji, Mark Jesus M Magbanua, Laura van t Veer, Karthik Giridhar, Matthew P. Goetz, Rita Mukhtar, Christos Vaklavas, Anthony D. Elias, Mei Wei, Gillian L. Hirst, Hope S. Rugo, Laura Ann Huppert, W. Fraser Fraser Symmans, Alexander D. Borowsky, Lamorna Brown Swigart, Natsuko Onishi, Douglas Yee, Nola Hylton, Laura Esserman, Jo Chien
Breast cancer diagnosis, management, and outcomes in transgender, nonbinary, and gender-diverse individuals: A multicenter cohort.
2025
Authors: Chandler Scott Cortina, Ruta Brazauskas, Meghan Rose Flanagan, Kathie-Ann P. Joseph, Rita Mukhtar, Olga Kantor, Kristen M. Rezak, Laura Horst Rosenberger, Sumanas Jordan, Rachel Jimenez, Katherine A. Kopkash, Tasha Hughes, Meeghan A. Lautner, Emily L. Siegel, Zahraa Alhilli, Michael Ryan Cassidy, Rachel L. McCaffrey, Marie Catherine Lee, Anna Weiss, Melinda Stolley
