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Background and aims: Patient-reported outcomes (PROs) will become increasingly important as primary endpoints in future clinical trials. We aimed to evaluate the relationship between health-related quality of life (HRQoL) and the combination of patient-reported clinical symptoms (ClinPRO2) and Mayo endoscopic subscore (MES) in patients with ulcerative colitis (UC). Methods: We conducted a prospective cross-sectional study of 90 consecutive UC patients who were scheduled for sigmoidoscopy or colonoscopy. All patients completed the following questionnaires: (1) self-rated rectal bleeding and stool frequency (ClinPRO2); (2) Short Inflammatory Bowel Disease Questionnaire (SIBDQ); (3) European Quality of Life 5-Dimensions 3-Level (EQ5D3L); (4) Work Productivity and Activity Impairment questionnaire (WPAI); (5) Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F); and (6) Hospital Anxiety and Depression Scale (HADS). The endoscopic images were graded according to the MES. “No symptoms” was defined as a symptom score of 0, and “mucosal healing” was defined as MES score of 0–1. Correlations between the combined ClinPRO2 and MES with HRQoL were assessed using Spearman’s correlation coefficients. Results: The combination of the ClinPRO2 and MES was well correlated to SIBDQ (r = −0.70), EQ5D3L (r = −0.51), WPAI (r = 0.62), FACIT-F (r = −0.58), and HADS-depression (r = 0.45). SIBDQ scores had strong correlations with FACIT-F (r = 0.86), WPAI (r = −0.80), and HADS-depression (r = −0.75) (p < 0.05 for all correlations). Patients with no symptoms reported the greatest all HRQoL scores. Conclusions: In patients with ulcerative colitis, the combination of a ClinPRO2 and the MES had good correlation with the SIBDQ. In addition, SIBDQ was well correlated to the various HRQoL.

BACKGROUND: Medication Therapy Management (MTM) is a strategy for developing a variety of non-dispensing clinical pharmacy services to patients which aim to optimize therapeutic outcomes by identifying and resolving drug therapy problems. We conducted a pilot study to see if MTM could serve as a measurable value-add as demonstrated by improved outcomes for IBD injectable biologic patients and reduced disease management burden for clinicians and office staff. METHODS: Adult patients with either UC or CD prescribed new self-injectable biologic agents (adalimumab [ADA], certolizumab pegol [CTZ], golimumab [GOL], or ustekinumab [USTE]) were recruited from outpatient clinics at Mayo Clinic Rochester, Arizona, Florida or Health System. Exclusion criteria included prescriptions that were refills, patients with need for urgent hospitalization, pregnant patients, those without a reliable and confirmed shipping address or reliable telephone access, or patients residing outside of the United States. Patients were randomized to receive standard care or be enrolled in a collaborative, high-touch MTM program administered by Curant Health PharmD's. Patients randomized to MTM were further stratified to either having medications filled by Curant Health or specialty pharmacy as dictated by insurance plan. Patients receiving standard care were managed as per discretion of the treating physician. Patients receiving MTM arms were contacted per a defined protocol with calls at specified time points. The primary outcome of interest was number of unsolicited calls/messages from patients to practice sites during the study time period along with total time spent on the managing of those messages either electronically or via telephone. Secondary outcomes of interest included medication adherence as defined by percent of patients with a score of >6 at week 24 (MMAS-8) and disease activity as measured by relevant disease indices. RESULTS: 20 patients were randomized to MTM and 19 to standard care. There was no difference in median age or sex distribution among groups. The majority of patients were started on ADA, 1 CTZ and 1 USTE. One patient was enrolled twice with different medications to the standard group. Nine MTM patients required additional support to optimize therapy with 1 patient requiring 6 additional calls. The majority of calls involved injection administration, how to treat injection site reaction, pain and misfiring. The number of unsolicited calls overall in the MTM arm were significantly higher than standard care: 3 vs 1 ( P < 0.05). The overall adherence to medication at week 24 was significantly higher with MTM; scores ranged from 7.5–8 vs 5.5–6 in the standard care group ( P < 0.05). The median disease score of the MTM group also improved significantly for both diseases by >50% at week 24 for 13/20 patients compared with 10/19 for standard group. CONCLUSION(S): Patients in the high-touch, collaborative MTM arm received additional engagement as evidenced by the significant increase in unsolicited patient calls. MTM patients also showed improved adherence and improved disease outcomes to injectable therapy. This suggests that MTM services are an effective mechanism to relieve burden of office staff while improving patient care.

Abstract Background Vedolizumab effectiveness estimates immediately after Food and Drug Administration (FDA) approval for ulcerative colitis (UC) and Crohn’s disease (CD) are limited by use in refractory populations. We aimed to compare treatment patterns and outcomes of vedolizumab in 2 time frames after FDA approval. Methods We used 2 data sets for time trend analysis, an academic multicenter vedolizumab consortium (VICTORY) and the Truven MarketScan database, and 2 time periods, May 2014–June 2015 (Era 1) and July 2015–June 2017 (Era 2). VICTORY cumulative 12-month clinical remission, corticosteroid-free remission, and mucosal healing rates, and Truven 12-month hospitalization and surgery rates, were compared between Eras 1 and 2 using time-to-event analyses. Results A total of 3661 vedolizumab-treated patients were included (n = 1087 VICTORY, n = 2574 Truven). In both cohorts, CD and UC patients treated during Era 2 were more likely to be biologic naïve. Compared with Era 1, Era 2 CD patients in the VICTORY consortium had higher rates of clinical remission (31% vs 40%, P = 0.03) and mucosal healing (42% vs 58%, P < 0.01). These trends were not observed for UC. In the Truven database, UC patients treated during Era 2 had lower rates of inflammatory bowel disease–related hospitalization (22.4% vs 9.6%, P < 0.001) and surgery (17.2% vs 9.4%, P = 0.008), which was not observed for CD. Conclusion Since FDA approval, remission and mucosal healing rates have increased for vedolizumab-treated CD patients, and vedolizumab-treated UC patients have had fewer hospitalizations and surgeries. This is likely due to differences between patient populations treated immediately after drug approval and those treated later.

Abstract Background We quantified loss of response (LOR) to vedolizumab (VDZ) in clinical practice and assessed the effectiveness of VDZ dose intensification for managing LOR. Methods Retrospective review (May 2014–December 2016) of a prospectively maintained inflammatory bowel disease (IBD) registry. Kaplan-Meier estimates were used to determine rates of LOR to VDZ . Independent predictors of LOR were identified using univariate and multivariable Cox proportional hazard regression. Success of recapturing response (>50% reduction in symptoms from baseline) and remission (complete resolution of symptoms) after dose intensification was quantified. Results Cumulative rates for VDZ LOR were 20% at 6 months and 35% at 12 months, with slightly lower rates in Crohn’s disease than in ulcerative colitis (6 months 15% vs 18% and 12 months 30% vs 39%, P = 0.03). On multivariable analysis, LOR to a tumor necrosis factor (TNF) antagonist before VDZ use was associated with an increased risk for LOR to VDZ [hazard ratio (HR) 1.93; 95% confidence interval (CI) 1.25–2.97] in all patients. For Crohn’s disease patients specifically, higher baseline C-reactive protein concentration was associated with increased risk for LOR to VDZ (HR 1.01 per mg/dL increase, 95% CI 1.01–1.02). Shortening of VDZ infusion interval from 8 to every 4 or 6 weeks recaptured response in 49% and remission in 18% of patients. Conclusions LOR to a TNF antagonist before VDZ use and higher baseline C-reactive protein are important predictors of VDZ LOR. Treatment response can be recaptured in almost half of these patients with VDZ infusion interval shortening.