Fecal calprotectin trends in immune-mediated colitis and their role in predicting treatment needs and clinical outcomes
Malek Shatila, Sharada Wali, Carolina Colli Cruz, Kian Abdul-Baki, Cristina Natha, Kei Takigawa, Tanvi Gupta, Andres Urias Rivera, Varun Vemulapalli, Linfeng Lu, Elliot Baerman, Hamza Salim, Andrew Sullivan, Irene Jeong-Ah Lee, Raakhi Menon, Ayesha Khan, Garrett Coleman, Helga-Paula Török, Bryan Schneider, Molly Thomas, Anusha Shirwaiker Thomas, Zhouxuan Li, Wei Qiao, Yinghong WangObjectives
Immune-mediated colitis (IMC) is a common toxicity of immune checkpoint inhibition. Fecal calprotectin is useful in the initial evaluation and surveillance of IMC. No studies have examined trends in calprotectin and its prognostic value. We explored these trends to identify clinically meaningful thresholds for changes in calprotectin.
Methods
This was a single-center retrospective study including all patients who received immune checkpoint inhibitors from January 2010 to February 2024, developed IMC, and whose calprotectin levels at diagnosis and afterward were available for analysis.
Results
Of the 767 patients meeting study criteria, 80.6% had elevated baseline calprotectin levels. Increased baseline calprotectin values were associated with the need for aggressive treatment (
Discussion
This is the first study to date to identify calprotectin cutoff values for predicting IMC outcomes. We found that baseline calprotectin values achieved high specificity in predicting future biologic therapy. Changes in calprotectin level by 2–3 months had a high specificity of 100% for clinical and endoscopic remission. Taken together, these findings suggest that fecal calprotectin can be a reliable biomarker to determine the need for biologic therapy for IMC and can be used to predict clinical and endoscopic remission.