Trial Outcomes & Findings for Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics (NCT NCT02316678)

NCT ID: NCT02316678

Last Updated: 2017-05-19

Results Overview

Incidence of death per 1000 person-years Outcome Measure Time Frame:Follow-up was from the date that the participant first met the criteria for either prolonged corticosteroid use or new anti-TNF use until either the patient died, discontinued enrollment in Medicaid or Medicare Part A, B, or D, reached age 90, was newly diagnosed with other immune-mediated diseases or AIDS, or reached the end of the available data, whichever came first, assessed up to 13 years. Follow-up of patients with UC also ended if they were diagnosed with a fistula, as this would usually change the diagnosis to CD.

• Recruitment status: COMPLETED
• Target enrollment: 9573 participants
• Primary outcome timeframe: See Outcome Measure Description above
• Results posted on: 2017-05-19

Participant Flow

This is a retrospective cohort study of Medicaid and Medicare beneficiaries with Inflammatory Bowel Disease (IBD) in the United States using administrative data. Medicaid data were from 2001-2005 and Medicare data were from 2006-2013.

Participant milestones

Measure	Anti-TNF - no Intervention Patients who are new users of anti-TNF therapy No intervention: There is no intervention	Corticosteroids - no Intervention Patients initiating corticosteroids No intervention: There is no intervention
Overall Study STARTED	1879	7694
Overall Study COMPLETED	1879	7694
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics

Baseline characteristics by cohort

Measure	Anti-TNF - no Intervention n=1879 Participants Patients who are new users of anti-TNF therapy No intervention: There is no intervention	Corticosteroids - no Intervention n=7694 Participants Patients initiating corticosteroids No intervention: There is no intervention	Total n=9573 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1323 Participants n=5 Participants	4838 Participants n=7 Participants	6161 Participants n=5 Participants
Age, Categorical >=65 years	556 Participants n=5 Participants	2856 Participants n=7 Participants	3412 Participants n=5 Participants
Age, Continuous	50.1 years STANDARD_DEVIATION 17.7 • n=5 Participants	53.2 years STANDARD_DEVIATION 18.8 • n=7 Participants	52.6 years STANDARD_DEVIATION 18.6 • n=5 Participants
Sex: Female, Male Female	1216 Participants n=5 Participants	4830 Participants n=7 Participants	6046 Participants n=5 Participants
Sex: Female, Male Male	663 Participants n=5 Participants	2864 Participants n=7 Participants	3527 Participants n=5 Participants
Region of Enrollment United States	1879 participants n=5 Participants	7694 participants n=7 Participants	9573 participants n=5 Participants

PRIMARY outcome

Timeframe: See Outcome Measure Description above

Population: Patients treated with corticosteroids (CS) within the prior year and subsequently received either additional CS therapy meeting the definition of prolonged CS use or newly initiated anti-TNF therapy were included in the study.

Incidence of death per 1000 person-years

Outcome Measure Time Frame:Follow-up was from the date that the participant first met the criteria for either prolonged corticosteroid use or new anti-TNF use until either the patient died, discontinued enrollment in Medicaid or Medicare Part A, B, or D, reached age 90, was newly diagnosed with other immune-mediated diseases or AIDS, or reached the end of the available data, whichever came first, assessed up to 13 years. Follow-up of patients with UC also ended if they were diagnosed with a fistula, as this would usually change the diagnosis to CD.

Outcome measures

Measure	Anti-TNF n=1879 Participants New users of anti-TNF therapy defined as ≥ 1 dispensing for an anti-TNF drug with ≥1 filled CS prescription and no dispensing for any anti-TNF medication in the 12 months preceding the first anti-TNF dispensing.	Steroids n=7694 Participants Prolonged users of steroids defined as either \>3000 mg of prednisone (or equivalent) or \>600 mg of budesonide divided between ≥2 prescriptions within 12 months and absence of any anti-TNF therapy during the same 12 months.
Mortality Rate	21.4 events per 1000 person-years	30.1 events per 1000 person-years

Adverse Events

Anti-TNF - no Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Corticosteroids - no Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James Lewis

University of Pennsylvania

Phone: 215-573-5137

Email: lewisjd@upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place