Yuanhua Lu, Xiaolin Chen, Qianru Chen, Queran Lin, Liling Zhu, Kai Chen
This pioneering real-world study provides exploratory evidence that adalimumab-based therapy as a first-line strategy for treatment-naive GLM may be associated with lower recurrence. Given the preliminary nature of these findings, further validation in larger studies is warranted. Key Points • First report of adalimumab as a first-line therapy in GLM. • Adalimumab-based regimens were associated with lower recurrence in this exploratory matched cohort. • Real-world evidence supports adalimumab-based therapy as a feasible first-line option.
OBJECTIVES: Granulomatous lobular mastitis (GLM) is a chronic inflammatory breast disease characterized by frequent relapses. Despite symptom relief achieved via treatments (e.g., intralesional corticosteroids) followed by observation, disease flares remain high. This exploratory real-world study aims to provide preliminary evidence on adalimumab as a potential first-line therapy for treatment-naïve GLM, focusing on its effect on recurrence.
METHODS: We retrospectively enrolled 51 eligible patients, of whom 7 received adalimumab-based first-line therapy, and the other 44 received non-adalimumab first-line regimens, which served as the potential control pool. After 1:3 propensity score matching based on age and baseline M-score, 7 adalimumab-treated patients and 21 matched controls from the pool entered the subsequent analyses. Data for all matched patients were assessed from June 2023 to December 31, 2025, or until their last clinical visit, whichever occurred first. Disease severity and response were evaluated using the M-score. The primary endpoint was the time to first recurrence.
RESULTS: After matching, baseline covariate balance was substantially improved. Recurrence-free time differed between the matched groups (log-rank P = 0.046). The matched-cohort Cox analysis suggested a lower recurrence hazard with adalimumab-based therapy, although the estimate was imprecise (HR, 0.15; 95% CI, 0.02-1.21). The estimated 6- and 12-month cumulative recurrence rate in the adalimumab group were both 14% (95% CI, 0-36.7%), compared with 19% (95% CI, 0.4-34.2%) and 48% (95% CI, 21.5-66.1%) in the control group, respectively. Safety was comparable between adalimumab and control group (P = 0.674).
CONCLUSION: This pioneering real-world study provides exploratory evidence that adalimumab-based therapy as a first-line strategy for treatment-naive GLM may be associated with lower recurrence. Given the preliminary nature of these findings, further validation in larger studies is warranted. Key Points • First report of adalimumab as a first-line therapy in GLM. • Adalimumab-based regimens were associated with lower recurrence in this exploratory matched cohort. • Real-world evidence supports adalimumab-based therapy as a feasible first-line option.