Ulcerative Colitis (UC)
Conditions
Brief summary
This study aims to evaluate whether adding CurQD, a nutraceutical composed of Curcumin and QingDai, improves treatment outcomes in patients with active ulcerative colitis (UC) who are already receiving Vedolizumab but still have ongoing disease activity. The study will use de-identified patient records collected through Evinature's global data platform. We will examine whether the addition of CurQD helps patients stay on Vedolizumab longer, improves symptoms and biomarkers, and increases satisfaction with treatment.
Detailed description
Curcumin and QingDai, (Indigo, QD) are two herbal traditional medicine compounds which have been investigated for their use in mild-moderate and moderate-severe UC, respectively. A combination of Curcumin and QD (CurQD), which was developed at Sheba Medical Center to maximize clinical efficacy while reducing long-term high-dose QD exposure, has been used in clinical practice in Israel since 2015 and has gained wide acceptance by UC patients and IBD experts \[1,2\]. In two multi-center retrospective studies, CurQD was found effective in inducing clinical and biomarker remission in both adult and pediatric patients, including in patients who were refractory to biologic and/or small molecules \[3,4\], and recent evidence from a pediatric cohort in the U.S also documented intestinal sonographic response to CurQD \[5\]. In a placebo-controlled randomized trial from Israel and Greece, CurQD was found superior to placebo in inducing and maintaining clinical and endoscopic remission without any safety signals \[6,7\]. Moreover, the study also showed the active compounds in CurQD exerts agonistic up-regulation of Aryl-hydrocarbon Receptor pathway in the rectal mucosa \[6\], supporting its unique non-immunosuppressive mode-of-action. Subsequently, CurQD has been increasingly used by IBD experts in academic centers in the USA and elsewhere as Add-on therapy in patients with partial or non-response to biologics and/or small molecules medications. Recently, CurQD became the first and only nutraceutical to date to pass the CCFA Ingestible committee examination of supporting clinical and scientific data to allow its endorsement by the CCFA. Collectively, these data provide the rationale for exploring large scale population-based impact of combining CurQD with a biologic. The present retrospective cohort study will interrogate the Evinature GDPR HIPAA compliant database to identify patients who started CurQD while being treated with VDZ. The study will investigate the clinical benefit of adding CurQD in combination with VDZ, in patients partially responding or not-responding to VDZ.
Interventions
DIETARY_SUPPLEMENTCurQD (Curcumin + QingDai combination)
Patients received CurQD in addition to Vedolizumab
Sponsors
Sheba Medical Center
Takeda Pharmaceuticals U.S.A., Inc.
Evinature Ltd.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>8 years * Diagnosis of ulcerative colitis (self-reported) * Completed Evinature clinical assessment between April 1, 2022, and cutoff date * Vedolizumab treatment at baseline * Active disease at entry (SCCAI ≥3 or PRO-2 ≥2 with RB ≥1) * Initiated CurQD at entry
Exclusion criteria
* Vedolizumab for indications other than UC * Unclear medication status at baseline * Not active disease when starting CurQD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Retaining Vedolizumab Treatment at Week 12 Following Addition of CurQD | Week 12 | Count of participants who remain on vedolizumab (VDZ) at Week 12 after initiating adjunct CurQD. Baseline clinical activity is defined as SCCAI ≥3 or PRO-2 ≥2 with rectal bleeding ≥1. Percentages will also be calculated relative to the number of participants with Week 12 data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Retaining Vedolizumab at Week 54 | Week 54 | Count of participants with ≥54 weeks of follow-up who remain on VDZ at Week 54 after starting CurQD. Percentages will also be calculated relative to the number of participants with Week 54 data |
| Number of Participants Achieving Clinical Remission at Week 12 | Week 12 | Clinical response is defined as SCCAI decrease ≥3, or PRO-2 decrease ≥2 with RB = 0 and SF ≤1, among participants with available baseline and follow-up values. Percentages will also be calculated relative to the number of participants with Week 12 clinical data. |
| Number of Participants Achieving Clinical Response at Week 54 | Week 54 | Same response definition as above. Percentages will also be calculated relative to the number of participants with Week 54 clinical data. |
| Number of Participants in Clinical Remission at Week 12 | Week 12 | Clinical remission defined as SCCAI ≤2 or PRO-2 = 0. Percentages will also be calculated relative to the number of participants with Week 12 clinical data. |
| Number of Participants in Clinical Remission at Week 54 | Week 54 | Same remission definition as above. Percentages will also be calculated relative to the number of participants with Week 54 clinical data. |
| Number of Participants Retaining Vedolizumab at Week 30 | Week 30 | Count of participants with ≥30 weeks of follow-up who remain on VDZ at Week 30 after starting CurQD. Percentages will also be calculated relative to the number of participants with Week 30 data. |
| Number of Participants Achieving Fecal Calprotectin (FCP) Response | Up to Week 54 | FCP response defined as ≥50% reduction from baseline among participants with baseline FCP ≥250 mcg/g and available follow-up FCP. Percentages will also be calculated relative to the number of participants with FCP measurements. |
| Number of Participants Achieving Fecal Calprotectin (FCP) Remission | Up to Week 54 | FCP remission defined as FCP \<150 mcg/g among participants with baseline FCP ≥250 mcg/g, following STRIDE II and GEMINI-I guidance. Percentages will also be calculated relative to the number of participants with FCP measurements. |
| Number of Participants Experiencing Treatment-Emergent Adverse Events | Baseline through Week 54 | Number and type of adverse events occurring during combined CurQD + VDZ therapy. Percentages will also be calculated relative to the number of participants exposed to both therapies. |
| Sensitivity Analysis: Number of Participants Retaining Vedolizumab at Week 12 with Baseline SCCAI ≥6 | Week 12 | Same definition as the primary endpoint but limited to participants with moderate-severe disease (baseline SCCAI ≥6). Percentages will also be calculated relative to the number of participants in this subgroup with Week 12 data. |
| Number of Participants Reporting Satisfaction with CurQD + Vedolizumab (VAS 1-10) | Week 12 | Number of participants providing a satisfaction score using a 1-10 Visual Analog Scale (VAS) after using CurQD + VDZ. Percentages will also be calculated relative to the number of participants who completed the VAS assessment. |
Countries
Israel
Outcome results
None listed