Risk of Incident IMID in Patients Treated With Biologics and Immunosuppressive Drugs for a Single IMID

NCT05696106 | Unknown

• 1 other identifier: PHRC-21-0113
• Study Type: observational
• Target: 750,000
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals with immune-mediated inflammatory diseases (IMIDs) are at increased risk of developing other IMIDs, possibly through shared pathogenic inflammatory pathways, and up to 25% of patients with IMIDs have at least one other IMID. Additionally, a concomitant diagnosis of a second IMID is associated with a higher burden of disease, which usually requires therapeutic escalation. Thus, this risk should be taken into account in the benefit-risk balance of IMIDs-related treatment. While the risk of other major adverse events, such as serious infection, cancer, and cardiovascular events, have been assessed in patients exposed to immunosuppressive drugs and biologics, the impact of these drugs on the risk of incident IMIDs remains largely unknown. The main aim of this study is to assess the risk of an incident second IMID in patients starting biologics including anti-TNF and immunosuppressive drugs including small molecules for a first IMID (either inflammatory bowel disease, inflammatory rheumatic diseases, or cutaneous psoriasis).

Conditions

Inflammatory Disease

Outcome Measures

Primary Outcomes (1)

• Occurrence of incident second IMID

  The primary outcome will be defined as the first occurrence of incident IMIDs after cohort entry, including: (Crohn's disease and ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, systemic lupus erythematosus, drug-induced lupus, sarcoidosis, vasculitis, crohn's disease and ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, systemic lupus erythematosus, drug-induced lupus, sarcoidosis, vasculitis). Identification algorithms used for inclusion criteria will be similarly used to assess outcomes. We performed a feasibility analysis by assessing the identification method of IBD diagnosis in patients previously diagnosed with either rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis. This analysis was based on a cohort of patients diagnosed with IBD between 1st January, 2008 and December 31st, 2018

  between 1st January, 2008 and December 31st, 2018

Secondary Outcomes (1)

• All the individual subtypes of second IMIDs included in the primary outcome definition

  between 1st January, 2008 and December 31st, 2018

Study Arms (1)

Patients initiating a biologic or immunosuppressive drug

Patients initiating a biologic or immunosuppressive drug including small molecules for a first IMID (either IBD, inflammatory rheumatic diseases, or cutaneous psoriasis) * Conventional immunosuppressive drug including immunomodulators (thiopurines) and csDMARDs (methotrexate) * Anti-TNF (infliximab, adalimumab, golimumab, certolizumab, etanercept) * Biologics targeting the IL-12/IL-23 pathways (ustekinumab, risankizumab, guselkumab) * Biologics targeting the IL-6 pathways (tocilizumab, sarilumab) * Biologics targeting the IL-17 pathways (secukinumab, ixékizumab, brodalumab) * Biologics targeting cell adhesion, anti-integrins (vedolizumab) * JAK inhibitors (tofacitinib, baricitinib, upadacitinib)

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

All the individual subtypes of second IMIDs included in the primary outcome definition, for which incidence during follow-up will be sufficient.

You may qualify if:

• Aged 18 years or older at index date (≥ 18 years)
• Identified with a first IMID diagnosis prior to index date, among IBD (Crohn's disease and ulcerative colitis), inflammatory rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis), or inflammatory skin diseases (psoriasis).

You may not qualify if:

• Patients with a diagnosis of more than one of the IMIDs of interest at index date.
• Patients exposed to biologics or immunosuppressive drugs of interest in 2006 or 2007.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Saint-Antoine

Paris, 75012, France

Location

Study Design

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

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 25, 2023
• Study Start: April 2, 2023
• Primary Completion: December 15, 2023
• Study Completion: January 15, 2024
• Last Updated: April 24, 2023

Record last verified: 2023-04

Locations

FR (1)