NCT05706038

Impact of Adalimumab Withdrawal or Continuation on Severity of COVID-19 and Risk of IMID Relapse

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 49 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a retrospective pharmacological study, of a historical cohort. Collection of Retrospective data from February 2020 to 30 September 2021 The index date is the date of COVID-19 positive PCR test. The data will be collected until last news (last clinical visit or death). There are no defined study visits. In the course of the study, the clinical data recorded are those corresponding to the standard medical procedure. The goal of this study is to assess the impact on continuing or stopping adalimumab treatment on the occurrence of a severe COVID-19 (Coronavirus Disease 2019) in patients with Immune-Mediated Inflammatory Disease (IMID), during the first month after the diagnosis of SARS-CoV-2 infection. To our knowledge, no comparisons have been performed between IMID patients stopping or not their maintenance treatment. In the context of the COVID-19 epidemic, the goal is to minimize the risk of disease flare while simultaneously minimizing the risk of severe COVID-19. In this study, we hypothesized that patients treated by adalimumab for IMID might not be susceptible to severe COVID-19 disease course.

Detailed description

Immune-mediated inflammatory disease (IBD or rheumatic disease) patients treated with adalimumab with positive PCR COVID-19 diagnosis will be enrolled by physicians. There will be four predefined and balanced group: 1. Adalimumab withdrawal in patients with IBD 2. Adalimumab continuation in patients with IBD 3. Adalimumab withdrawal in patients with RA, PsA, axSpA, and nrxSpA 4. Adalimumab continuation in patients with RA, PsA, axSpA, and nrxSpA n = 312 subjects for groups 1+3 together and 312 subjects for groups 2+4 together. All data will be described by percentages (categorical variables) and mean +/- standard deviation and quartiles (continuous variables). The median time of follow-up survival data will also be detailed for each event of interest (admission to intensive care unit, need to a mechanical ventilation during hospitalization, death). Kaplan Meier curve will describe the probability of the occurrence of a severe SARS-CoV-2 infection (see primary endpoint for definition). Time to analysis - better define - time to severity of the event. Occurrence (yes/no)

Conditions

• Inflammatory Bowel Diseases
• Rheumatic Disorder

Interventions

Type	Name	Description
DRUG	Adalimumab	Adalimumab is a fully human, high-affinity, recombinant anti-tumor necrosis factor (TNF) alpha monoclonal antibody used to treat rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, Crohn disease, ulcerative colitis, etc. Adalimumab is a fully human, high-affinity, recombinant immunoglobulin G (IgG) anti-TNF alpha monoclonal antibody. It is a molecule comprising 1330 amino acids and has a molecular weight of approximately 148 kDa.\[4\] It inhibits the binding of TNF alpha (both soluble and membrane-bound) to its receptor. Specifically, it inhibits TNF alpha's interaction with p55 (TNFR1) and p75 (TNFR2) cell surface TNF receptors, which in turn interferes with cytokine-driven inflammatory processes. It is identical in structure and function to the naturally occurring human IgG1 and thus has high selectivity for TNF alpha and has low immunogenic potential.

Timeline

• Start date: 2022-04-27
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2023-01-31
• Last updated: 2023-01-31

Locations

1 site across 1 country: Italy