"Clinical and Epidemiological Characteristics of Inflammatory Rhinitis in Patients on Biotherapies" (RIB18)

Inflammatory rhinitis is a side effect observed in patients treated with biotherapies in the context of chronic bowel disease (IBD) or spondylartrhopathy (SPA). This damage is still poorly described in the literature. I The objective of this study is to study the associated characteristics of crustal rhinitis in a cohort of patients treated with biotherapy for chronic inflammatory disease (IBD, SPA, psoriasis).

Study Overview

• Status: Completed
• Conditions: Inflammatory Rhinitis
• Intervention / Treatment: Other: survey

Detailed Description

Inflammatory rhinitis is a side effect observed in patients treated with biotherapies in the context of chronic bowel disease (IBD) or spondylartrhopathy (SPA). This damage is still poorly described in the literature. It can occur in isolation or in association with a fold pustulose table, which differs from the classic fold pustulose described by Cribier et al in autoimmune diseases by the presence of staphylococcus aureus in the pustules. Some authors also describe associated paradoxical psoriasiform reactions or an impetigo. In our experience, this condition is more frequently found in patients treated for IBD or SPA and has a clinically characteristic fissure appearance. Thus, the semiology but also the epidemiology of this crusty rhinitis is still poorly described.

The objective of this study is to study the associated characteristics of crustal rhinitis in a cohort of patients treated with biotherapy for chronic inflammatory disease (IBD, SPA, psoriasis).

Patient recruitment will take place over a one-year period, in a multi-centre manner (Angers and Nantes University Hospital) with prospective data collection in the form of a questionnaire and clinical evaluation during a dermatology consultation planned in the traditional care pathway for the follow-up of patients with skin manifestations during biotherapy treatment.

• Study Type: Observational
• Enrollment (Actual): 356

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • University Hospital

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: Non-Probability Sample

Study Population

Recruitment of patients on biotherapies that meet the inclusion criteria as exhaustively as possible.

• Major patients, followed at the University Hospital of Angers and Nantes, in the dermatology, gastroenterology and rheumatology departments for chronic inflammatory diseases requiring treatment with biotherapy started at least 3 months ago.
• Recruitment during consultations in the specialties concerned or in the day hospitals planned for the administration of treatments.

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Description

Inclusion Criteria:

• Adult patient (> 18 years of age),
• Biotherapy treatment: anti TNF, ustekinumab, secukinumab, ixekizumab, Rituximab, vedolizumab, abatacept, inhibitor jak kinase, anti Il1, Anti Il6,
• Biotherapy treatment > 3 months,
• Chronic inflammatory disease: psoriasis, ankylosing spondylitis (SPA), rheumatoid arthritis (RA), Crohn's disease (CD), bleeding rectocolitis (HRC)
• No opposition to the study

Exclusion Criteria:

• Patient under legal protection measure,
• Refusal of the subject to participate in the study,

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of inflammatory rhinitis	Presence of inflammatory rhinitis yes/no	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characteristics associated with Patient-related characteristics in inflammatory rhinitis.	Age; Tobacco use yes/no; Diabetes yes/no; Verneuil disease yes/no; Psoriasis yes/no; Eczema in childhood yes/no; Underlying pathology (type, start year); Previous biotherapies and duration of exposure over the last 3 years yes/no	through study completion, an average of 1 year
Characteristics of rhinitis.	Delays between the start of treatment and the onset of symptoms; Treatment under which rhinitis occurred; Rhinitis stage; Permanent or recurring, unilateral or bilateral; Associated functional signs (rhinorrhea, pain...); Quality of Life (DLQI); Presence of documented endonasal staphylococcus yes/no; Positivity of anti-nuclear antibodies yes/no; Type of treatment carried out	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2019
• Primary Completion (Actual): June 19, 2020
• Study Completion (Actual): June 19, 2020

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Rhinitis
• Other Study ID Numbers: RC18_0397