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Poster Session C - Monday Afternoon

C0280 - Patient Compliance With Vibrating Capsule Predicts Outcome in Chronic Idiopathic Constipation (CIC)

Monday, October 24, 2022

3:00 PM – 5:00 PM ET

Location: Crown Ballroom

Presenting Author(s)

Eamonn M. Quigley, MD, MACG

Houston Methodist Hospital
Houston, TX

Eamonn M. Quigley, MD, MACG¹, Satish Rao, MD², William D. Chey, MD³, Bryan F. Curtin, MD⁴, Christine Frissora, MD⁵, Brennan Spiegel, MD, FACG⁶, Darren Brenner, MD⁷, Anthony Lembo, MD, FACG⁸
¹Houston Methodist Hospital, Houston, TX; ²Augusta University, Augusta, GA; ³Michigan Medicine, Ann Arbor, MI; ⁴Mercy Medical Center, Baltimore, MD; ⁵Weill Cornell Medicine, New York, NY; ⁶Cedars Sinai, Los Angeles, CA; ⁷Northwestern Medical Group, Chicago, IL; ⁸Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA

Introduction: Many patients with chronic idiopathic constipation (CIC) are dissatisfied with available medications, suggesting a need for new therapies. A recent phase III trial showed that an orally ingested vibrating capsule (VC) improved stool frequency, bowel and abdominal symptoms and quality of life in patients with CIC. Our aim was to evaluate the impact of compliance/adherence on efficacy of the VC in a post-hoc analysis of a Phase III trial.

Methods: Many patients with chronic idiopathic constipation (CIC) are dissatisfied with available medications, suggesting a need for new therapies. A recent phase III trial showed that an orally ingested vibrating capsule (VC) improved stool frequency, bowel and abdominal symptoms and quality of life in patients with CIC.

In this 8-week randomized double-blind placebo-controlled Phase III trial, activation of the vibrating capsule (Vibrant®, Yokne'am Illit, Israel) was automatically and remotely recorded, permitting accurate assessment of compliance. Two outcomes were analyzed: CSBM₁, an increase of ≥ 1 CSBM/week and CSBM₂, an increase of ≥ 2 CSBMs/week, averaged over the study period and compared to baseline.

Results:

Patients whose adherence to the recommended number of capsules was >32 capsules ingested over the 8 weeks of treatment (n=117), (out of the recommended 5 capsules per week X 8 weeks = 40 capsules), had higher response rates for both CSBM₁ and CSBM₂, compared to either the entire study population or those who ingested < 32 capsules per week (n=42) (Figure and Table).

Discussion: Patients with CIC with >80% adherence to capsule dosing frequency had a superior response, supporting the appropriateness of the proposed dosing schedule. By virtue of its design, this first in class system enables accurate monitoring of compliance when assessing clinical response.

Figure: Figure 1: Primary outcome measures showing proportion of complete spontaneous bowel movement 1 and 2 (CSBM1 and CSBM2) responders according to compliance rate and in comparison to the entire study population (intention-to-treat analysis)

VC (Vibrant^)

Mean change from baseline ITT [95% CI]

Placebo

Mean change from baseline ITT [95% CI]

P-value

(χ² test)

Entire Study

Population

(ITT population from

Phase III study)

VC n=163

Placebo n=149

CSBM₁

39.26%

[32.10%;46.93%]

22.15%

[16.23%;29.47%]

0.0011

CSBM₂

22.70%

[16.94%;29.72%]

11.41%

[7.25%;17.51%]

0.0085

ITT < 80% compliance

VC n=117

Placebo n=117

CSBM₁

26.09%

[15.601%;40.26%]

6.25%

[1.73%;20.15%]

0.0247

CSBM₂

13.40%

[6.12%;25.67%]

3.13%

[0.55%;15.74%]

0.229)

ITT >=80%

compliance

VC n=46

Placebo n=32

CSBM₁

44.44%

[35.76%;53.48%]

26.50%

[19.34%;35.15%]

0.0041

CSBM₂

26.50%

[19.34%;35.15%]

13.68% [8.60%;21.06%]

0.0144

Table: Table 1: Impact of compliance on relative efficacy of vibrating capsule (VC) and placebo

Disclosures:

Eamonn Quigley: Biomerica – Grant/Research Support. Vibrant – Advisor or Review Panel Member. Vibrant – Clinical Advisory Board.

Satish Rao: Salix Pharmaceuticals – Grant/Research Support. Vibrant – Advisor or Review Panel Member. Vibrant – Clinical Advisory Board.

William Chey: Abbvie – Consultant. Allakos – Consultant. Alnylam – Consultant. Arena – Consultant. Biomerica – Consultant. Commonwealth Diagnostics International – Consultant. Gemelli – Consultant. GI OnDEMAND – Stock Options. Ironwood – Consultant. Isothrive – Consultant. Isothrive – Stock Options. Modify Health – Stock Options. Nestle – Consultant. Phathom – Consultant. Progenity – Consultant. QOL Medical – Consultant, Grant/Research Support. Redhill – Consultant. Salix – Consultant, Grant/Research Support. Urovant – Consultant. Vibrant – Consultant.

Bryan Curtin: Vibrant – Advisor or Review Panel Member.

Christine Frissora: Vibrant – Advisor or Review Panel Member.

Brennan Spiegel: Vibrant – Advisor or Review Panel Member.

Darren Brenner: Salix Pharmaceuticals – Consultant. Vibrant – Advisor or Review Panel Member.

Anthony Lembo: Alkermes – Consultant. Arena Pharmaceuticals, Inc. – Consultant. Bayer – Consultant. Bristol-Myers Squibb – Stock Options. Gemelli Biotech – Consultant. Ironwood Pharmaceuticals, Inc. – Consultant. Johnson & Johnson – Stock Options. OrphoMed, Inc. – Consultant. Salix Pharmaceuticals, Inc. – Consultant. Shire, a Takeda company – Consultant. Takeda Pharmaceuticals – Consultant. Vibrant – Advisor or Review Panel Member. Vibrant Pharma Inc. – Consultant.

Eamonn M. Quigley, MD, MACG¹, Satish Rao, MD², William D. Chey, MD³, Bryan F. Curtin, MD⁴, Christine Frissora, MD⁵, Brennan Spiegel, MD, FACG⁶, Darren Brenner, MD⁷, Anthony Lembo, MD, FACG⁸. C0280 - Patient Compliance With Vibrating Capsule Predicts Outcome in Chronic Idiopathic Constipation (CIC), ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.