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

Inflammatory Disease Clinical Trial

— PROTECT-IMID  

Official title:

Risk of Incident Immune-mediated Inflammatory Diseases (IMID) in Patients Treated With Biologics and Immunosuppressive Drugs for a Single IMID

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05696106
• Other study ID #: PHRC-21-0113
• Status: Active, not recruiting
• Start date: April 2, 2023
• Est. completion date: January 15, 2024

Study information

• Verified date: April 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

This is a retrospective cohort study including all patients identified with a first IMID between 2008 and 2020 based on the French administrative healthcare databases (Système National des Données de Santé). Index date will be the date of initiation of the first treatment of interest within the observation period.

Primary objective

• 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 IBD, inflammatory rheumatic diseases, or cutaneous psoriasis)

Secondary objectives

• To describe the subtype of incident second IMIDs in patients starting biologics and immunosuppressive drugs for a first IMID and the related burden of disease.

• To assess the risk of an incident second IMID in patients starting biologics and immunosuppressive drugs for a first IMID, according to each drug class:

• 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)

• To assess the risk of an incident second IMID in patients with a first incident IMID (after January 1st, 2008) and starting biologics and immunosuppressive drugs for this IMID.

• To assess the risk of an incident second IMID in patients starting biologics and immunosuppressive drugs for a first IMID:

• By type of first IMID

• By type of second IMID

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 750000
• Est. completion date: January 15, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Inflammatory Disease

Locations

Country	Name	City	State
France	Hôpital Saint-Antoine	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All the individual subtypes of second IMIDs included in the primary outcome definition	All the individual subtypes of second IMIDs included in the primary outcome definition, for which incidence during follow-up will be sufficient.; Burden of disease will be based on healthcare resource utilization, notably hospitalizations, emergency department visits, outpatient visits, and drug deliveries.	between 1st January, 2008 and December 31st, 2018