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
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

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

Criteria

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