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

NCT02922192 | Completed DMC

• 1 other identifier: BBCIC-Anti-inflammatory
• Study Type: observational
• Target: 90,360
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis; Inflammatory Bowel Disease; Psoriasis; Psoriatic Arthritis; Ankylosing Spondylitis

Keywords

Anti-inflammatory; Biologics; Biologic and Biosimilars Collective Intelligence Consortium; BBCIC

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Rheumatoid arthritis (RA)

With exposure to TNF-α antagonists, non-TNFs, DMARD non-biologics

Drug: TNF-α antagonists, non-TNFs, DMARD non-biologics

Inflammatory bowel disease (IBD)

With exposure to TNF-α antagonists, non-TNFs, DMARD non-biologics

Drug: TNF-α antagonists, non-TNFs, DMARD non-biologics

Psoriatic conditions

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

Interventions

TNF-α antagonists, non-TNFs, DMARD non-biologics DRUG

Exposure to TNF- α antagonists, non-TNF- α antagonists, oral DMARD, or non-biologic agents.

Also known as: 18 drug names in TNF, non-TNFs, DMARD non-biologics

Inflammatory bowel disease (IBD); Psoriatic conditions; Rheumatoid arthritis (RA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study subjects are selected according to inclusion criteria from a source population within the Sentinel Common Data Mode v5.0.1 (SCDM). The SCDM includes over 100 million individuals with 358 million person-years of observation time who are covered by Aetna, Anthem, Group Health Cooperative, Harvard Pilgrim Health Care, and HealthPartners. The time period assessed will be 1/1/2006 - 9/30/2015.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

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

Related 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. 2021 Feb;9(1):e00708. doi: 10.1002/prp2.708.

  PMID: 33372729 RESULT

Related 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.

MeSH Terms

Conditions

Arthritis, Rheumatoid; Inflammatory Bowel Diseases; Psoriasis; Arthritis, Psoriatic; Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Axial Spondyloarthritis; Ankylosis

Study Officials

• Kevin Haynes, PharmD, MSCE

  Anthem HealthCore, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 4, 2016
• Study Start: January 1, 2012
• Primary Completion: March 31, 2019
• Study Completion: June 1, 2020
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share