Autori: Kolář M., Malíčková K., Bortlík M., Pudilová K., Ďuricová D., Lukáš M., Machková N., Hrubá V., Lukáš M.
Pracovisko: Klinické a výzkumné centrum pro střevní záněty ISCARE I.V.F. a.s., Praha, Česká republika
Abstrakt:
Objective: We evaluated response to UST in a cohort of complicated patients and its association with trough levels (TLs).
Methods: Data from consecutive patients who failed on at least one biologic were included. Disease activity was assessed by PGA from 0 (remission) to 3 (severe) at week 0 and every 8 weeks. At week 24, patients were considered as complete responders (CR) with PGA drop of at least 2 points, partial responders (PR) with drop of 1 point or no responders (NR) with 0 or negative decrease in PGA. CRP, FC and UST TLs were measured at every visit.
Results: 29 CD patients with mean age of 35.9 years were included. Mean disease duration was 15.2 years. Proximal disease was present in 24.1% of patients and the same proportion suffered from perianal disease. At baseline, 20.7% of patients had severe disease activity, 62.1% had moderate and 17.2% mild or no current disease activity. Severe activity was present in 10.7% of patients, 50% had moderate and 39.3% mild or no activity at week 8. At week 24 the proportions were 8.7%, 47.8% and 43.5%, respectively, however, there was no decrease in mean CRP and FC between the two timepoints (CRP 11.2±15.5 mg/L vs. 12.6±16.5 mg/L, p=0.8838; FC 1724±1718 μg/g vs. 1611±1830 μg/g, p=0.9277). Patients with moderate to severe disease activity had significantly lower UST TLs at both week 8 and 24 (12.9±10.1 μg/mL vs. 23.2±11.8 μg/mL, p=0.0090 at week 8 and 3.9±1.9 μg/mL vs. 7.1±3.8 μg/mL, p=0.0351 at week 24). 52% of patients experienced at least PR according to PGA decrease between baseline and week 24, while 48% didn’t respond. There was no difference in UST TLs at week 8 between patients who did and didn’t respond at week 24, however responders had significantly higher week 24 UST TLs (7.5±3.7 μg/mL vs. 3.8±1.9 μg/mL, p=0.0145).
Conclusion: Despite no decrease in inflammatory markers, over 50% of refractory CD Patients experienced clinical benefit from UST after 24 weeks which was associated with higher UST serum levels.