Impact of Adalimumab Withdrawal or Continuation on Severity of COVID-19 and Risk of IMID Relapse (COV-ADA)

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Rheumatic Disorder
• Intervention / Treatment: Drug: Adalimumab

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)

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20132
    • IRCCS Ospedale San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
composite endpoint: occurrence of an admission to intensive care unit and/or need to a mechanical ventilation during hospitalization and/or death	The primary endpoint is the occurrence of a severe SARS-CoV-2 infection, which will be defined by a composite endpoint: occurrence of an admission to intensive care unit and/or need to a mechanical ventilation during hospitalization and/or death, during the first month after the diagnosis of SARS-CoV-2 infection.	first month after the diagnosis of SARS-CoV-2 infection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurrence of IMID flare	to measure the occurrence of IMID flare, which will be assessed by the occurrence of a disease flare until last clinical visit, to evaluate risk factors for severe COVID-19, and to evaluate risk factors for IMID flare. IMID flare is defined by patient requiring medical intervention (additional treatment and/or dose escalation and/or surgery and/or hospitalization).	from diagnosis of SARS-CoV-2 infection to enrollment

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Investigators: Principal Investigator: Silvio Danese, IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 27, 2022
• Primary Completion (ACTUAL): October 31, 2022
• Study Completion (ACTUAL): October 31, 2022

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (ACTUAL): January 31, 2023

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: COV-ADA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No