Curcumin-QingDai Combination for Patients With Active Crohn's Disease: Initial Real-World Experience from a Retrospective Multicenter Cohort Study
Background:
A combination of curcumin and QingDai (CurQD) was shown to be effective in ulcerative colitis but its benefit in Crohn’s disease (CD) has not been studied.
Methods:
This was a retrospective cohort study of patients with active CD treated with CurQD at 2 tertiary academic centers. Active disease was defined by a PRO-2 score>4 or a fecal calprotectin (FCP) >250 mcg/gr. The primary endpoint was the rate of clinical remission at the end-of-induction by weeks 8- 12, defined as PRO2 drop of ≥50% and a score ≤4. Secondary endpoints included clinical response defined as PRO2 drop of ≥50%, biomarker response (FCP drop ≥50% in a patient with FC<italic>P ></italic>250 mcg/gr at baseline) and remission (FCP drop ≥50% and FCP<250 mcg/gr) as well as safety of CurQD.
Results:
26 patients treated between July 2022-June 2024 were identified and 25 were included for extraction of their clinical charts’ data (52% females, median age 30 years-old, 25-75% IQR 20.5-44.5). Of 25 patients, 16 (64%) had L1 disease without colonic involvement, 15/25 (60%) had moderate to severe activity (PRO2≥14), and 10/25 (40%) were bio-experienced. At the end of induction, clinical remission was achieved in 13/25 (52%) of patients and clinical response in 14/25 (56%), with an overall reduction in median PRO2 score from 15 (95%CI 10-18) to 4 (95%CI 2-9, <italic>P<</italic>0.001). Biomarker remission and response were observed in 8/15 (53%) and 12/15 (80%), respectively, of patients with available before- after FCP results who had a baseline FCP>250 mcg/gr, with an overall reduction in median FCP from a baseline value of 600 (95%CI 259-1144) to 140 mcg/mL (95%CI 88-266, p=0.001). On subgroup analysis, clinical remission at end-of-induction was achieved in 7/16 (44%) versus 6/9 (66%) of patients with small-bowel L1 disease versus ileocolonic or colonic disease, respectively (OR 0.39, 95%CI 0.32- 1.3, p=0.28) and biomarker remission in 3/9 (33%) versus 5/6 (83%) of patients (OR 0.4, 95%CI 0.15-1.07, p=0.077). During a median follow-up of 8 months (25-75% IQR 4.5-10), 18/25 (72%) were still taking CurQD. Three patients experienced headaches and 3 had abdominal pain or diarrhea. Two of the 6 stopped CurQD due to these symptoms. One patient had elevated liver transaminases X3 of ULN which resolved upon halving CurQD dose.
Conclusions:
In this first-reported experience, CurQD was effective in inducing clinical and biomarker remission in CD patients, including in biologic-experienced patients, and was retained during maintenance treatment in three-quarters of patients. A signal for better efficacy in patients with colonic or ileocolonic disease merits further investigation.