"Clinical and Epidemiological Characteristics of Inflammatory Rhinitis in Patients on Biotherapies"
- Conditions
- Inflammatory Rhinitis
- Registration Number
- NCT04132258
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 356
- 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
- Patient under legal protection measure,
- Refusal of the subject to participate in the study,
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of inflammatory rhinitis through study completion, an average of 1 year Presence of inflammatory rhinitis yes/no
- Secondary Outcome Measures
Name Time Method Characteristics associated with Patient-related characteristics in inflammatory rhinitis. through study completion, an average of 1 year * 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/noCharacteristics of rhinitis. through study completion, an average of 1 year * 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
Trial Locations
- Locations (1)
University Hospital
🇫🇷Nantes, France