P037 Effect of Ozanimod Treatment and Discontinuation on Absolute Lymphocyte Count in Moderate-to-Severe Ulcerative Colitis: Results from a Phase 3 Trial.

Background: Ozanimod is an oral sphingosine 1-phosphate (S1P) receptor modulator selectively targeting S1P1 and S1P5, which reduces migration of lymphocytes involved in adaptive immunity from lymphoid tissues to blood and inflamed tissues while preserving components of the innate immune response. Ozanimod is approved in multiple countries for the treatment of relapsing forms of multiple sclerosis and in the US for the treatment of moderately-to-severely active ulcerative colitis (UC). The reduction of circulating lymphocytes is expected based on the mechanism of action of ozanimod and thought to be an important driver of efficacy.

Ozanimod as Induction and Maintenance Therapy for Ulcerative Colitis.

Background: Ozanimod, a selective sphingosine-1-phosphate receptor modulator, is under investigation for the treatment of inflammatory bowel disease.

Methods: We conducted a phase 3, multicenter, randomized, double-blind, placebo-controlled trial of ozanimod as induction and maintenance therapy in patients with moderately to severely active ulcerative colitis. In the 10-week induction period, patients in cohort 1 were assigned to receive oral ozanimod hydrochloride at a dose of 1 mg (equivalent to 0.

Effects of Apremilast, an Oral Inhibitor of Phosphodiesterase 4, in a Randomized Trial of Patients With Active Ulcerative Colitis.

Background & Aims: New oral therapeutic agents are needed for patients with ulcerative colitis (UC) who are unresponsive or intolerant to conventional therapy.

Methods: We performed a double-blind, phase 2 trial of adults with active UC for 3 months or more who were naïve to biologic therapy or had been failed by, could not tolerate, or had contraindications to conventional therapies. The study was performed at 61 sites in 14 countries (screening from January 2015 through May 2017).

The role of psychological factors in pediatric functional abdominal pain disorders.

Background: Pediatric functional abdominal pain disorders (FAPDs) are disorders of brain-gut dysregulation. Psychological factors are known to be related to etiology, maintenance, and exacerbation of pediatric FAPDs. With the evolving literature in the past two decades, a better understanding has emerged of precisely which psychological factors are associated with childhood FAPDs.

Safety and efficacy of intramuscular human placenta-derived mesenchymal stromal-like cells (cenplacel [PDA-002]) in patients who have a diabetic foot ulcer with peripheral arterial disease.

The objective of this study was to examine the safety of cenplacel (PDA-002) in patients with peripheral arterial disease (PAD) and a diabetic foot ulcer (DFU). Cenplacel is a mesenchymal-like cell population derived from full-term human placenta. This phase 1, dose-escalation study investigated cenplacel in diabetic patients with chronic DFUs (Wagner grade 1 or grade 2) and PAD [ankle-brachial index (ABI) >0·5 and ≤0·9], enrolled sequentially into each of four dose cohorts (3 × 10 , 10 × 10 , 30 × 10 and 100 × 10 cells; administered intramuscularly on study days 1 and 8 in combination with standard of care).

Partial remission in ankylosing spondylitis and non-radiographic axial spondyloarthritis in treatment with infliximab plus naproxen or naproxen alone: associations between partial remission and baseline disease characteristics.

Objectives: To evaluate partial remission during treatment with infliximab (IFX) + naproxen (NPX) vs NPX alone in patients from the two subgroups of SpA and explore baseline predictors of partial remission.

Methods: Infliximab as First Line Therapy in Patients with Early Active Axial Spondyloarthritis Trial was a double-blind, randomised controlled trial of IFX in biologic-naïve patients with early, active axial SpA. Patients were randomised (2:1) to receive 28 weeks of treatment with i.

Aprepitant triple therapy for the prevention of chemotherapy-induced nausea and vomiting following high-dose cisplatin in Chinese patients: a randomized, double-blind, placebo-controlled phase III trial.

Purpose: Aprepitant, an oral neurokinin-1 receptor antagonist, has demonstrated improved control of chemotherapy-induced nausea and vomiting (CINV) in previous studies. This is the first phase III study to evaluate the efficacy and tolerability of aprepitant in patients receiving highly emetogenic chemotherapy (HEC) in Asian countries.

Methods: This multicenter, double-blind, placebo-controlled trial assessed the prevention of CINV during the acute phase (AP), delayed phase (DP), and overall phase (OP).

Evaluation of etoricoxib in patients undergoing total knee replacement surgery in a double-blind, randomized controlled trial.

Background: Optimal postoperative pain management is important to ensure patient comfort and early mobilization.

Methods: In this double-blind, placebo- and active-controlled, randomized clinical trial, we evaluated postoperative pain following knee replacement in patients receiving placebo, etoricoxib (90 or 120 mg), or ibuprofen 1800 mg daily for 7 days. Patients ≥18 years of age who had pain at rest ≥5 (0-10 Numerical Rating Scale [NRS]) after unilateral total knee replacement were randomly assigned to placebo (N = 98), etoricoxib 90 mg (N = 224), etoricoxib 120 mg (N = 230), or ibuprofen 1800 mg (N = 224) postoperatively.

Direct medical costs of constipation from childhood to early adulthood: a population-based birth cohort study.

Background: Although direct medical costs for constipation-related medical visits are thought to be high, to date there have been no studies examining whether longitudinal resource use is persistently elevated in children with constipation. Our aim was to estimate the incremental direct medical costs and types of health care use associated with constipation from childhood to early adulthood.

Methods: A nested case-control study was conducted to evaluate the incremental costs associated with constipation.

Lack of utility of abdominal x-rays in the evaluation of children with constipation: comparison of different scoring methods.

Background And Aim: Abdominal x-rays are used diagnostically in the evaluation of children with constipation. However, their clinical utility has not been established. The aim of the study was to assess the accuracy of different methods in identifying children with functional constipation (FC) or nonretentive fecal incontinence (NRFI).

Unexplained gastrointestinal symptoms after abuse in a prospective study of children at risk for abuse and neglect.

Purpose: Unexplained gastrointestinal symptoms are more common in adults who recall abuse as a child; however, data available on children are limited. The aim of this study was to investigate the association of childhood maltreatment and early development of gastrointestinal symptoms and whether this relation was mediated by psychological distress.

Methods: Data were obtained from the Longitudinal Studies of Child Abuse and Neglect, a consortium of 5 prospective studies of child maltreatment.

Audio-recorded guided imagery treatment reduces functional abdominal pain in children: a pilot study.

Objective: This study was designed to develop and to test a home-based, guided imagery treatment protocol, using audio and video recordings, that is easy for health care professionals and patients to use, is inexpensive, and is applicable to a wide range of health care settings.

Methods: Thirty-four children, 6 to 15 years of age, with a physician diagnosis of functional abdominal pain were assigned randomly to receive 2 months of standard medical care with or without home-based, guided imagery treatment. Children who received only standard medical care initially received guided imagery treatment after 2 months.

Parental worries and beliefs about abdominal pain.

Background: Solicitous parental responses to stomachaches may perpetuate chronic abdominal pain in children. Discussing these issues in clinical practice is difficult because parents feel misunderstood and blamed for their child's pain. Focusing on parental worries and beliefs that motivate solicitous responses may be better accepted.

Recollection of childhood abdominal pain in adults with functional gastrointestinal disorders.

Objective: It is hypothesized that adults who can recall abdominal pain as children are at risk of experiencing a functional gastrointestinal disorder (FGID), but this is not specific to any particular FGID. The aim of this study was to evaluate the association between recollecting abdominal pain as a child and experiencing a FGID.

Material And Methods: A valid self-reported questionnaire of GI symptoms was mailed to a random population-based sample in Olmsted County, Minnesota.

Contributions of pain sensitivity and colonic motility to IBS symptom severity and predominant bowel habits.

Objectives: Irritable bowel syndrome (IBS) patients show pain hypersensitivity and hypercontractility in response to colonic or rectal distention. Aims were to determine whether predominant bowel habits and IBS symptom severity are related to pain sensitivity, colon motility, or smooth muscle tone.

Methods: One hundred twenty-nine patients classified as IBS with diarrhea (IBS-D, N = 44), IBS with constipation (IBS-C, N = 29), mixed IBS (IBS-M, N = 45), and unspecified IBS (IBS-U, N = 11) based on stool consistency, and 30 healthy controls (HC) were studied.

Ambulatory care for constipation in the United States, 1993-2004.

Objectives: Chronic constipation is one of the most common disorders seen in primary care. In order to examine longitudinal changes in the ambulatory care that occur in constipation evaluation and management, we examined national trends in physician office visits associated with constipation between 1993 and 2004.

Methods: Data were derived from the National Ambulatory Medical Care Survey (NAMCS) and the National Hospital Ambulatory Care Survey (NHAMCS) for 1993-2004.

Early life risk factors that contribute to irritable bowel syndrome in adults: a systematic review.

Background: Irritable bowel syndrome (IBS) is a common disorder that occurs in adults. The natural history of symptoms and risk factors that contribute to IBS may begin in childhood. The aim of this systematic review was to determine what early life factors contribute to the development of IBS in adolescents and adults.

Medical presentation of constipation from childhood to early adulthood: a population-based cohort study.

Background & Aims: Constipation is a common disorder in children and adults, but the role of gender and early life risk factors remains undefined. The aims of the study were as follows: (1) to estimate the incidence of medical presentation for constipation in a population-based birth cohort, and (2) to examine factors associated with constipation presentation from childhood to adulthood.

Methods: A birth cohort of all children born between 1976 and 1982 to mothers who were residents of Rochester, Minnesota, and who remained in the community until age 5 was used for this study.

Pharmacotherapy for functional gastrointestinal disorders in children.

Functional gastrointestinal disorders are among the most common medical problems in pediatrics. However, only a few well-designed trials have evaluated the efficacy and safety of treatments in these conditions. Data obtained from studies conducted in adults are often utilized to tailor treatment to children with functional gastrointestinal disorders.

Incidence of presentation of common functional gastrointestinal disorders in children from birth to 5 years: a cohort study.

Background & Aims: Gastroesophageal reflux disease (GERD), abdominal pain of unknown origin, and constipation are thought to be causes for frequent medical visits during childhood. The aim of this study was to estimate the incidences, repeat presentation, clinical symptoms, and sociodemographic risk factors in children who medically presented for GERD, abdominal pain of unknown origin, and constipation from birth to 5 years.

Methods: This was a population-based, retrospective birth cohort study of all children born to mothers residing in Rochester, Minnesota who remained in the area until at least age 5 (n = 5718).

Aerophagia and rumination: recognition and therapy.

Aerophagia and rumination syndrome are functional upper gastrointestinal disorders that are becoming increasingly recognized in otherwise-healthy children and adults. Aerophagia is primarily characterized by troublesome repetitive belching and abdominal symptoms that result from air sucking and swallowing. Rumination syndrome is primarily characterized by regurgitation occurring shortly after meal intake.