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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922192
• Other study ID #: BBCIC-Anti-inflammatory
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: June 1, 2020

Study information

• Verified date: July 2023
• Source: Biologics & Biosimilars Collective Intelligence Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90360
• Est. completion date: June 1, 2020
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -a 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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Psoriatic
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Psoriasis
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• TNF-a antagonists, non-TNFs, DMARD non-biologics
Exposure to TNF- a antagonists, non-TNF- a antagonists, oral DMARD, or non-biologic agents.

Locations

Country	Name	City	State
n/a

Sponsors (13)

Lead Sponsor	Collaborator
Biologics & Biosimilars Collective Intelligence Consortium	AbbVie, Aetna, Inc., Amgen, Boehringer Ingelheim, Harvard Pilgrim Health Care, HealthCore, Inc., Kaiser Permanente, Merck Sharp & Dohme LLC, Momenta Pharmaceuticals, Inc., Pfizer, University of Alabama; Rheumatologist and Healthcare Research, University of Pittsburgh

References & Publications (1)

Mendelsohn AB, Nam YH, Marshall J, McDermott CL, Kochar B, Kappelman MD, Brown JS, Lockhart CM. Utilization patterns and characteristics of users of biologic anti-inflammatory agents in a large, US commercially insured population. Pharmacol Res Perspect. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) was established in 2015 to address anticipated needs for post-marketed evidence generation for novel biologics, their corresponding biosimilars and other related products.