Clinical trial NCT05706038: Impact of Adalimumab Withdrawal or Continuation on Severity of COVID-19 and Risk of IMID Relapse
Official title: Impact of Adalimumab Withdrawal or Continuation on Severity of COVID-19 and Risk of IMID Relapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Rheumatic Disorder
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective pharmacological study of a historical cohort: retrospective data from February 2020 to September 2021.

Immune-mediated inflammatory disease (IBD or rheumatic disease) patients treated with adalimumab with positive Polymerase Chain Reaction (PCR) COVID-19 diagnosis.

624 patients will be needed (of whom 312 with maintenance of treatment).

Brief 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)

Eligibility criteria: Inclusion Criteria:

1. age ≥ 18 years
2. diagnosis of immune-mediated inflammatory disease:

   1. IBD: CD, UC or undetermined colitis
   2. Rheumatic diseases: RA, PsA, axSpA, and nrx SpA
3. patients treated with adalimumab for IMID at time of SARS-CoV-2 infection diagnosis
4. COVID-19 positive PCR test
5. minimum treatment duration on adalimumab of 3 months before SARS-CoV-2 infection diagnosis
6. minimum follow-up of one month after SARS-CoV-2 infection diagnosis

Exclusion Criteria:

1. Adalimumab withdrawal for other reasons than SARS-CoV-2 infection
2. Patients with COPD or lung co-morbidities
3. Pregnant, parturient, or breastfeeding woman
4. Minor person (non-emancipated)
5. Adult person under legal protection (any form of public guardianship)
6. Adult person incapable of giving consent and not under legal protection
7. Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1 of the Public Health Code.

Primary outcomes:
measure: composite endpoint: occurrence of an admission to intensive care unit and/or need to a mechanical ventilation during hospitalization and/or death
timeFrame: first month after the diagnosis of SARS-CoV-2 infection
Secondary outcomes:
measure: occurrence of IMID flare
timeFrame: from diagnosis of SARS-CoV-2 infection to enrollment
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Irccs Ospedale San Raffaele
Study officials:
affiliation: IRCCS San Raffaele
name: Silvio Danese
role: PRINCIPAL_INVESTIGATOR
References: