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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rheumatoid Arthritis, Inflammatory Bowel Disease, Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis

Intervention / Treatment
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* Drug: TNF-α antagonists, non-TNFs, DMARD non-biologics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rheumatoid arthritis (RA)<br>With exposure to TNF-α antagonists, non-TNFs, DMARD non-biologics | Drug: TNF-α antagonists, non-TNFs, DMARD non-biologics<br>* Exposure to TNF- α antagonists, non-TNF- α antagonists, oral DMARD, or non-biologic agents.<br>* Other names: 18 drug names in TNF, non-TNFs, DMARD non-biologics;|
| Inflammatory bowel disease (IBD)<br>With exposure to TNF-α antagonists, non-TNFs, DMARD non-biologics | Drug: TNF-α antagonists, non-TNFs, DMARD non-biologics<br>* Exposure to TNF- α antagonists, non-TNF- α antagonists, oral DMARD, or non-biologic agents.<br>* Other names: 18 drug names in TNF, non-TNFs, DMARD non-biologics;|
| Psoriatic conditions<br>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<br>* Exposure to TNF- α antagonists, non-TNF- α antagonists, oral DMARD, or non-biologic agents.<br>* Other names: 18 drug names in TNF, non-TNFs, DMARD non-biologics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hospitalization for serious infections | 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). | Anticipated completion January 2017 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-inflammatory, Biologics, Biologic and Biosimilars Collective Intelligence Consortium, BBCIC