Abstract Background A combination of Curcumin and QingDai (CurQD) is effective as add-on treatment in ulcerative colitis (UC) but data on its utility in combination with vedolizumab (VDZ) is still limited Methods This is an interim analysis of a retrospective cohort study. The Evinature’s IBD database was queried to identify VDZ-treated patients, who started CurQD for self-reported active UC (SCCAI≥3 or PRO2≥2 and RB ≥ 1). The primary outcome was VDZ drug retention at week 12 (W12) of combination treatment with VDZ+CurQD Results 67 patients were included (64% females, median age 37 years-old). Median disease duration was six years (25-75% IQR 3-9) and disease extent was extensive UC in 25/67, 12 left-sided, 13 proctitis, and 17 with unknown extent. 47/67 (70.1%) patients had previously received corticosteroids, and 28/67 (41.8%) were previously treated with another biologic or a small molecule, making VDZ their second or more line of advanced treatment. Median duration of VDZ treatment when starting CurQD was 6 months, 35/67 (52.2%) of the patients were receiving shortened-interval infusions of VDZ or a subcutaneous formulation and 8/67 (11.9%) were treated with dual biologic-small molecule at baseline. Clinical response (SCCAI drop≥3) at W12 was observed in 41/67 (61.2%) patients, with a significant W0 to W12 drop in the median SCCAI (5, 95%CI 4-6, to 2, 95%CI 2-3, p 0.001, Wilcoxon rank test). Median calprotectin decreased from 546 (95%CI336-794, n = 32) to 82 (95%CI 32-262, n = 14), which was statistically significant in the nine patients with paired W0-W12 results (458, 95%CI 158-2739 to 177,95%CI 32-347, p = 0.03, respectively, Figure). Of the 27/67 patients receiving corticosteroids at baseline, 10/27 (37%) were able to be weaned off corticosteroids by W12 after addition of CurQD. For the primary endpoint, 64/67 (95.5%) patients continued VDZ at W12. Excluding patients with a recent start of CurQD less than 30 and 54 weeks before the date of data lock, 32/55 (58.2%) and 13/29 (44.8%) remained on VDZ at week 30 and 54, respectively. The corresponding CurQD retention rates were 100%, 78.2% and 65.5%, at week 12, 30 and 54, respectively. Adverse events included headaches (6/67), elevated liver enzymes (3/67) and abdominal pain (2/67) which did not cause discontinuation of CurQD. Patients’ satisfaction from CurQD addition by VAS scale of 1-10 was high with a median of 9 (95%CI 8-10) Conclusion In this interim analysis of a real-world biologic-refractory cohort of UC patients with inadequate response to VDZ, the addition of CurQD resulted in significant drug retention and clinical and biomarker response. Larger, preferably prospective, data are warranted to corroborate these findings Conflict of interest: Johnston, Kathryn: Employee of Evinature Mazor, Shiri: Employee of Evinature Tehar-Lev, Shirli: Employee of Evinature Salomon, Nir: Consultancy fees and equity in Evinature Ben-Horin, Shomron: Grant: Abbvie, Takeda, Janssen, Celltrion, Pfizer, Medtronic, Galmed, OutSense Personal Fees: Advisory board and/or consulting and/or Speaker fees from Abbvie, Takeda, Janssen, Celltrion, Pfizer, GSK, Ferring, Novartis, Roche, Gilead, NeoPharm, EviNature, Galmed, Medial Earlysign, BMS, Pfizer, Falk, Medtronic and Eli Lilly. Options/stocks in Predicta Med, Evinature, Galmed, Alma Therpeautics. The present study was funded by Takeda Pharmaceuticals, USA
Johnston et al. (Thu,) studied this question.
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