Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis

Sponsor

Biologics & Biosimilars Collective Intelligence Consortium (Other)

Overall Status

Completed

CT.gov ID

NCT02922192

Collaborator

HealthCore, Inc. (Industry), Aetna, Inc. (Industry), University of Alabama; Rheumatologist and Healthcare Research (Other), AbbVie (Industry), Amgen (Industry), Boehringer Ingelheim (Industry), Kaiser Permanente (Other), Harvard Pilgrim Health Care (Other), Merck Sharp & Dohme LLC (Industry), Momenta Pharmaceuticals, Inc. (Industry), Pfizer (Industry), University of Pittsburgh (Other)

90,360

Enrollment

101

Actual Duration (Months)

Study Details

Study Description

Brief Summary

Purpose:

With the existing biologic anti-inflammatory product patents expiring and the FDA approval of new biosimilar and innovator biologics, patients with rheumatologic (RA), psoriatic (PsO-PsA-AS), and gastrointestinal (GI) conditions will have additional therapeutic options. This observational study will describe the patient characteristics of new users of Tumor Necrosis Factor-α (TNF) antagonists, non-TNF- α antagonists, oral DMARD, and non-biologic agents. It will describe in the treatment cohorts outcomes of serious infections that require hospitalization. The BBCIC will use the findings from this descriptive analysis to design a comparative study evaluating the real-world effectiveness and safety of biosimilar and innovator anti-inflammatory biologics.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Inflammatory Bowel Disease Psoriasis Psoriatic Arthritis Ankylosing Spondylitis	Drug: TNF-α antagonists, non-TNFs, DMARD non-biologics

Detailed Description

Additional information:

To most effectively interpret results from this descriptive analysis it is important to consider that this protocol was not designed to support a hypothesis. This information is being provided to the public in the interest of transparency and for demonstrating the BBCIC's Distributed Research Network's (DRN) ability to define exposures, outcomes, covariates and confounders. When published, the report will caution that the protocol does not support any ability to compare safety or effectiveness but instead is to be used only to explore the feasibility of future, more detailed comparative analyses and to better understand the capabilities of the BBCIC project. Further, the report will caution that information from this protocol should not affect use of the medical products described in any way and the fact that the BBCIC is performing this descriptive analysis in no way suggests there is a safety or effectiveness issue with any of the products described.

Study Design

Study Type:

Observational

Actual Enrollment :

90360 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis

Actual Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Mar 31, 2019

Actual Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Rheumatoid arthritis (RA) With exposure to TNF-α antagonists, non-TNFs, DMARD non-biologics	Drug: TNF-α antagonists, non-TNFs, DMARD non-biologics Exposure to TNF- α antagonists, non-TNF- α antagonists, oral DMARD, or non-biologic agents. Other Names: 18 drug names in TNF, non-TNFs, DMARD non-biologics
Inflammatory bowel disease (IBD) With exposure to TNF-α antagonists, non-TNFs, DMARD non-biologics	Drug: TNF-α antagonists, non-TNFs, DMARD non-biologics Exposure to TNF- α antagonists, non-TNF- α antagonists, oral DMARD, or non-biologic agents. Other Names: 18 drug names in TNF, non-TNFs, DMARD non-biologics
Psoriatic conditions Patients with a psoriasis, psoriatic arthritis, ankylosing spondylitis with exposure to TNF-α antagonists, non-TNFs, DMARD non-biologics	Drug: TNF-α antagonists, non-TNFs, DMARD non-biologics Exposure to TNF- α antagonists, non-TNF- α antagonists, oral DMARD, or non-biologic agents. Other Names: 18 drug names in TNF, non-TNFs, DMARD non-biologics

Arm

Intervention/Treatment

Rheumatoid arthritis (RA)

With exposure to TNF-α antagonists, non-TNFs, DMARD non-biologics

Drug: TNF-α antagonists, non-TNFs, DMARD non-biologics

Exposure to TNF- α antagonists, non-TNF- α antagonists, oral DMARD, or non-biologic agents.

Other Names:

18 drug names in TNF, non-TNFs, DMARD non-biologics

Inflammatory bowel disease (IBD)

With exposure to TNF-α antagonists, non-TNFs, DMARD non-biologics

Drug: TNF-α antagonists, non-TNFs, DMARD non-biologics

Exposure to TNF- α antagonists, non-TNF- α antagonists, oral DMARD, or non-biologic agents.

Other Names:

18 drug names in TNF, non-TNFs, DMARD non-biologics

Psoriatic conditions

Patients with a psoriasis, psoriatic arthritis, ankylosing spondylitis with exposure to TNF-α antagonists, non-TNFs, DMARD non-biologics

Drug: TNF-α antagonists, non-TNFs, DMARD non-biologics

Exposure to TNF- α antagonists, non-TNF- α antagonists, oral DMARD, or non-biologic agents.

Other Names:

18 drug names in TNF, non-TNFs, DMARD non-biologics

Outcome Measures

Primary Outcome Measures

Incidence of hospitalization for serious infections [Anticipated completion January 2017]
Primary: Incidence of hospitalization for serious infections (i.e., infections of the respiratory tract, skin and soft tissue, genito-urinary tract, gastrointestinal tract, central nervous system, septicemia/sepsis).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Individuals with baseline period of 365 days with continuous medical and pharmacy coverage preceding the first prescription fill
new and users of the following exposures
TNF -α antagonists (including adalimumab, certolizumab, etanercept [not included for IBD], golimumab, infliximab, and natalizumab [IBD only])
Non-TNF-alpha antagonist biologics in RA only (abatacept, rituximab, and tocilizumab)
Non-biologic medications (after any use of methotrexate in the previous year includes RA: hydroxychloroquine, leflunomide, or sulfasalazine; IBD: 6- mercaptopurine or azathioprine; PsO-PsA-AS: methotrexate, leflunomide, or sulfasalazine).

Exclusion Criteria:

During baseline 365 days, any patient with
Active cancer or a history of non-melanoma cancer*
Any immunocompromising conditions (organ transplantation, HIV, and advanced kidney/liver disease)*
*if occur during the follow-up period, patients also will be censored.
During baseline 183 days, any patient with hospitalization for any infection