ABSTRACT
Introduction: Guselkumab (GUS), an IL-23p19 antagonist, had greater efficacy than placebo (PBO) in achieving clinical response and clinical remission atWeek (Wk) 12 in the randomized, controlled Phase 2b QUASAR Induction Study 1 (NCT04033445) in patients with moderately to severely active ulcerative colitis (UC).1 Patients who were not in clinical response at Wk 12 received GUS treatment through Wk 24. Here, we report GUS cumulative efficacy and safety results for Induction Study 1. Method(s): Eligible patients had moderately to severely active UC (modified Mayo score of 5 to 9 with a Mayo endoscopy subscore >=2) at baseline. Patients were randomized 1:1:1 to IV GUS 200mg, 400mg, or PBO at Wks 0, 4, and 8. Patients who were not in clinical response to IV induction at Wk 12 received GUS treatment (PBO IV->GUS 200mg IV;GUS 200mg IV->GUS 200mg SC;GUS 400mg IV->GUS 200mg SC) at Wks 12, 16, and 20 and were evaluated at Wk 24 (Figure). Matching IV or SC PBO was administered to maintain the blind. Result(s): Three hundred thirteen patients were randomized and treated at baseline. Demographic and disease characteristics at baseline were similar among the treatment groups, and approximately 50% had a prior inadequate response or intolerance to advanced UC therapy. AtWk 12, clinical response was achieved by 61.4% (62/101) and 60.7% (65/107) of patients randomized to GUS 200mg and GUS 400mg IV vs 27.6 % (29/105) of patients randomized to PBO IV (both p< 0.001). Of the patients in the GUS groups who were not in clinical response at Wk 12, 54.3% (19/35) in the GUS 200mg IV->200mg SC group and 50.0% (19/38) in the GUS 400mg IV->200mg SC group achieved clinical response at Wk 24. Clinical response atWk 12 or 24 was achieved by 80.2% of patients who were randomized to GUS 200mg IV and 78.5% of patients who were randomized to GUS 400mg IV. For patients who received PBO IV->GUS 200mg IV, clinical response at Wk 24 (65.2%) was similar toWk 12 clinical response following GUS 200mg IV induction (61.4%). The most frequent adverse events among all GUS-treated pts (n=274) were anemia (7.7%), headache (5.1%), worsening UC (4.4%), COVID-19 (3.6%), arthralgia (2.9%) and abdominal pain (2.6%) which are consistent with Wk 12 results. Conclusion(s): Overall, approximately 80% of patients randomized to receive GUS achieved clinical response at Wk 12 or 24. Continued treatment with SC GUS allowed 50-54.3% of IV GUS Wk 12 clinical nonresponders to achieve clinical response at Wk 24. No new safety concerns for GUS were identified. (Figure Presented).
ABSTRACT
Background: Guselkumab (GUS), an IL-23p19 antagonist, had greater efficacy than placebo (PBO) in achieving clinical response and clinical remission at Week (Wk) 12 in the randomized, controlled Phase 2b QUASAR Induction Study 1 (NCT04033445) in patients with moderately to severely active ulcerative colitis (UC).1 Patients who were not in clinical response at Wk 12 received GUS treatment through Wk 24. Here, we report GUS cumulative efficacy and safety results for Induction Study 1. Method(s): Eligible patients had moderately to severely active UC (modified Mayo score of 5 to 9 with a Mayo endoscopy subscore >=2) at baseline. Patients were randomized 1:1:1 to IV GUS 200mg, 400mg, or PBO at Wks 0, 4, and 8. Patients who were not in clinical response to IV induction at Wk 12 received GUS treatment (PBO IVGUS 200mg IV;GUS 200mg IV->GUS 200mg SC;GUS 400mg IV->GUS 200mg SC) at Wks 12, 16, and 20 and were evaluated at Wk 24 (Figure 1). Matching IV or SC PBO was administered to maintain the blind. Result(s): Three hundred thirteen patients were randomized and treated at baseline. Demographic and disease characteristics at baseline were similar among the treatment groups, and approximately 50% had a prior inadequate response or intolerance to advanced UC therapy. At Wk 12, clinical response was achieved by 61.4% (62/101) and 60.7% (65/107) of patients randomized to GUS 200mg and GUS 400mg IV vs 27.6% (29/105) of patients randomized to PBO IV (both p<0.001). Of the patients in the GUS groups who were not in clinical response at Wk 12, 54.3% (19/35) in the GUS 200mg IV->200mg SC group and 50.0% (19/38) in the GUS 400mg IV->200mg SC group achieved clinical response at Wk 24. Clinical response at Wk 12 or 24 was achieved by 80.2% of patients who were randomized to GUS 200mg IV and 78.5% of patients who were randomized to GUS 400mg IV. For patients who received PBO IV->GUS 200mg IV, clinical response at Wk 24 (65.2%) was similar to Wk 12 clinical response following GUS 200mg IV induction (61.4%). The most frequent adverse events among all GUS-treated pts (n=274) were anemia (7.7%), headache (5.1%), worsening UC (4.4%), COVID-19 (3.6%), arthralgia (2.9%) and abdominal pain (2.6%) which are consistent with Wk 12 results. Conclusion(s): Overall, approximately 80% of patients randomized to receive GUS achieved clinical response at Wk 12 or 24. Continued treatment with SC GUS allowed 50-54.3% of IV GUS Wk 12 clinical nonresponders to achieve clinical response at Wk 24. No new safety concerns for GUS were identified.
ABSTRACT
Background: Given the social distancing measures employed to reduce the transmission of SARS-CoV-2, tele-health has rapidly expanded and is now routinely used in new patient encounters and in follow up appointments across Canada. Aims: To determine the patient and physician perspective towards tele-health in a gastroenterology outpatient setting. Methods: An anonymous voluntary online survey was distributed to patients who had previously undergone at least one tele-health visit in a tertiary care gastroenterology outpatient setting. A separate online survey was distributed to gastroenterologists practising across Canada. Results: A total of 181 patients from British Columbia (59.8% female) completed the survey. The tele-health appointment was the first visit for 21.8% of patients. Appointments occurred by phone call alone (61.4%) or by video and audio software (38.6%) and started within 5 minutes of the scheduled time in 75% of visits. Patient satisfaction with the tele-health visit was high (8.54 on a scale of 0-10;0 completely dissatisfied, 10 extremely satisfied;IQR 8-10). Most patients did not perceive a difference in likelihood of compliance compared to a non-tele-health visit (90.6%), were not concerned about the lack of physical exam during a tele-health visit (82.4%) and did not with-hold information they would have revealed in person (88.7%). After the COVID-19 pandemic, some patients would prefer tele-heath visits (39.2%), whereas others would prefer in office visits (28.5%) and the remainder were indifferent (32.3%). Post-pandemic, most patients would prefer tele-health for follow up visits (68.4%), over tele-health for all possible visits (27.9%) or no tele-health visits (3.8%). A total of 25 Canadian gastroenterologists (28.0% female;60% academic practice, 40% community practice) completed a separate survey. Regarding the lack of physical exam in tele-health, 44% of physicians believed this did not affect the quality of their assessment, whereas some physicians believed it had either minimally (48%) or greatly (8%) impaired the quality of their assessment. Almost all physicians (96%) perceived that patients either appreciate tele-health as much as or more than in office visits. Post-pandemic, most physicians (96%) supported a hybrid model of both tele-health and in office visits. Appointments for follow up of benign endoscopic pathology results (96%), follow up visits (92%), consultations prior to endoscopy (76%) were deemed to be most appropriate for tele-health. Follow up of malignant pathology results (24%) and consultations for new patients (32%) were thought to be less appropriate for tele-health visits. Conclusions: Patient and physician satisfaction with tele-health in a Canadian outpatient gastroenterology setting is high. Most patients and physicians wish for telehealth to remain available in the post-pandemic setting.
ABSTRACT
Background: With the COVID-19 pandemic, the demand and availability of telehealth in outpatient care has increased. Although use of telehealth has been studied and validated for various medical specialties, relatively few studies have looked at its role in gastroenterology despite burden of chronic diseases such as inflammatory bowel disease (IBD). Aims: To assess effectiveness of telehealth medicine in gastroenterology by comparing medication adherence rate for patients seen with telehealth and traditional in-person appointment for various GI conditions. Methods: Retrospective chart analysis of patients seen in outpatient gastroenterology clinic was performed to identify patients who were given prescription to fill either through telehealth or in-person appointment. By using provincial pharmacy database, we determined the prescription fill rate. Results: A total of 241 patients were identified who were provided prescriptions during visit with their gastroenterologists. 128 patients were seen through in-person visit during pre-pandemic period. 113 patients were seen through telehealth appointment during COVID pandemic. The mean age of patients in telehealth cohort was 42 years (57% male). On average patients had 10 prior visits with their gastroenterologists before index appointment, used for adherence assessment. 92% of patients were seen in follow-up, while 8% were seen in initial consultation. The majority of the patients in the telehealth cohort had IBD (89%), while the remaining 11% had various diagnoses, including functional GI disorder, gastroesophageal reflux disease, viral hepatitis, or hepatobiliary disorders. Biologic therapy was the most commonly prescribed medication (66.4%). 45 patients were provided either new medication or dose change, and 68 patients had prescription refill to continue their current medications. It took a mean of 18 days (SD = 16.2) for patients to fill their prescriptions. Prescription fill rate for patients seen through telehealth and in-person visit were 98.2% and 89.1% (P = 0.004) respectively. Patients seen through telehealth were 6.8 times more likely to fill their prescriptions compared to the in-person counterparts (OR 6.82, CI 1.51 - 30.68, P = 0.004). When we compared adherence rate while excluding biologic therapies, the prescription fill rate was 94.7% in telehealth group and 81.4% in in-person group (OR 4.11, CI 0.88 - 19.27, P = 0.056). Due to high level of adherence, statistical analysis comparing adherent and non-adherent groups was performed but yielded insignificant results. Conclusions: Medication adherence rate for patients seen through telehealth was higher compared to patients seen through in-patient visit in this study. Telehealth is a viable alternative for outpatient care especially for patients with chronic GI conditions such as IBD.