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

NCT02922192

CompletedN/A

Sponsor: Biologics & Biosimilars Collective Intelligence Consortium

Conditions: Rheumatoid Arthritis, Inflammatory Bowel Disease, Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis

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

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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