Ankylosing Spondylitis, Inflammatory Bowel Disease, Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis
Conditions
Keywords
Anti-inflammatory, Biologics, Biologic and Biosimilars Collective Intelligence Consortium, BBCIC
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.
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.
Interventions
DRUGTNF-α antagonists, non-TNFs, DMARD non-biologics
Exposure to TNF- α antagonists, non-TNF- α antagonists, oral DMARD, or non-biologic agents.
Sponsors
HealthCore, Inc.
Aetna, Inc.
University of Alabama; Rheumatologist and Healthcare Research
AbbVie
Amgen
Boehringer Ingelheim
Kaiser Permanente
Harvard Pilgrim Health Care
Merck Sharp & Dohme LLC
Momenta Pharmaceuticals, Inc.
Pfizer
University of Pittsburgh
Biologics & Biosimilars Collective Intelligence Consortium
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Outcome results
None listed