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Clinical and Epidemiological Characteristics of Inflammatory Rhinitis in Patients on Biotherapies

Clinical and Epidemiological Characteristics of Inflammatory Rhinitis in Patients on Biotherapies

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04132258
Acronym
RIB18
Enrollment
356
Registered
2019-10-18
Start date
2019-11-19
Completion date
2020-06-19
Last updated
2021-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Rhinitis

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.

Interventions

OTHERsurvey

(presence of certain antecedents, weight, height, current or past existence of inflammatory rhinitis) and a second by the specialist doctor (pathology at the origin of the start of biotherapy, year of beginning of treatment, previous biotherapies over the last 3 years).

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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,

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of inflammatory rhinitisthrough study completion, an average of 1 yearPresence of inflammatory rhinitis yes/no

Secondary

MeasureTime frameDescription
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/no
Characteristics 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026