Clinical trial NCT02922192: Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis
Official title: Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Inflammatory Bowel Disease
Psoriasis
Psoriatic Arthritis
Ankylosing Spondylitis
Keywords: Anti-inflammatory
Biologics
Biologic and Biosimilars Collective Intelligence Consortium
BBCIC
Lead sponsor: Biologics & Biosimilars Collective Intelligence Consortium
Sponsor class: OTHER
Collaborators: name: HealthCore, Inc.
name: Aetna, Inc.
name: University of Alabama; Rheumatologist and Healthcare Research
name: AbbVie
name: Amgen
name: Boehringer Ingelheim
name: Kaiser Permanente
name: Harvard Pilgrim Health Care
name: Merck Sharp & Dohme LLC
name: Momenta Pharmaceuticals, Inc.
name: Pfizer
name: University of Pittsburgh
First posted: 2016-10-04
Enrollment: 90360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Incidence of hospitalization for serious infections
timeFrame: Anticipated completion January 2017
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Anthem HealthCore, Inc.
name: Kevin Haynes, PharmD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.