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

• Status: Completed
• Trial end date: 2020-06-01

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.

Details

• Lead Sponsor: Biologics & Biosimilars Collective Intelligence Consortium
• Collaborators: AbbVie; Aetna, Inc.; Amgen; Boehringer Ingelheim; Group Health Cooperative; Harvard Pilgrim Health Care; HealthCore, Inc.; Kaiser Permanente; Merck Sharp & Dohme Corp.; Momenta Pharmaceuticals, Inc.; Pfizer; University of Alabama; Rheumatologist and Healthcare Research; University of Pittsburgh; UPMC
• Treatments: Anti-Inflammatory Agents; Antirheumatic Agents