Pharmacogenetic Studies on Anti-IL-6 Receptor Monoclonal Antibodies on the Treatment of Rheumatic Diseases

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau140 enrolled

Overview

Tocilizumab and Sarilumab are first-line biological disease-modifying anti-rheumatic drug (bDMARD) which inhibits Interleukin 6 (IL-6) pathway through blockade of its receptor on the treatment of Rheumatoid Arthritis and other rheumatic diseases as Giant Cell Arteritis, Still's disease and Idiopathic Juvenile Arthritis. At present, there is a lack of evidence to recommend the treatment of one bDMARD over another. Seeking for genetic biomarkers to predict response to treatment could be key towards a personalized treatment strategy in rheumatology. The investigators aime to evaluate whether functional single nucleotide polymorphisms (SNPs) in the IL6R gene could predict response and/or toxicity in patients with rheumatic diseases treated with anti-IL-6 receptor drugs.

Study Type

OBSERVATIONAL

Enrollment

140

Conditions

Rheumatoid Arthritis Idiopathic Juvenile Arthritis Giant Cell Arteritis Still Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of Rheumatoid Arthritis by the American College of Rheumatology (ACR) 2010 criteria or * Diagnosis of Giant Cell Arteritis by the International League of Associations for Rheumatology (ILAR) criteria or * Diagnosis of Still disease by classification criteria (Yamaguchi et al.) or * Diagnosis of Idiopathic Juvenile Arthritis by ACR 1990 criteria. * All of the previous must have been treated with anti-IL-6R monoclonal antibodies in the last 5 years Exclusion Criteria: * \<18 years at recruitment * Another rheumatic disease different of the ones in the inclusion criteria

Outcomes

Primary Outcomes

DAS28-C-reactive Protein (CRP) change

Activity measure for patients with Rheumatoid Arthritis (RA)

Time frame: at 6 months

Rate of adverse events

Known adverse events during treatment with anti-IL6R drugs

Time frame: During treatment with anti-IL6R drugs

CRP change

Acute phase reactant reduction in the other diseases different of RA.

Time frame: 6 months

Erythrocyte sedimentation rate (ESR) change