Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 15 May 2018
Erelzi in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.
Erelzi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Erelzi is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Etanercept, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Juvenile idiopathic arthritis
Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. Etanercept has not been studied in children aged less than 2 years.
Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of
peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Ankylosing spondylitis (AS)
Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Non-radiographic axial spondyloarthritis
Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to non-steroidal anti-inflammatory drugs
Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA).
Paediatric plaque psoriasis
Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
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The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily (QD) is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis ...
Added 1 year ago
Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)
- To demonstrate that sarilumab monotherapy is superior to adalimumab monotherapy with respect to signs and symptoms as assessed by disease activity score 28...
Added 4 years ago
The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) ...
Added 6 years ago
The purpose of this study is to determine whether baricitinib therapy alone is noninferior to methotrexate (MTX) therapy alone in in the treatment of moderate to severe active rheumatoid arthritis (RA)...
Added 6 years ago
The purpose of this study is to determine whether baricitinib is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) ...
Added 6 years ago
The Budget Impact of Biosimilar Infliximab (Remsima®) for the treatment of autoimmune diseases in five European countries.
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Added 1 year ago
No increased incidence of inflammatory bowel disease among secukinumab-treated patients with moderate to severe psoriasis, psoriatic arthritis, or ankylosing spondylitis: data from 14 phase 2 and phase 3 clinical studies.
Secukinumab (SEC), a fully human anti–interleukin-17A monoclonal antibody, has been evaluated and approved for the treatment of moderate to severe psoriasis (PsO), active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS).
Added 9 months ago
Secukinumab safety and tolerability in patients with active psoriatic arthtitis and psoriasis: Results from pooled safety analysis.
Secukinumab, a fully human anti–interleukin-17A monoclonal antibody, has been shown to improve the signs and symptoms of psoriasis and psoriatic arthritis (PsA).
Added 9 months ago
Efficacy and safety of interleukin-1 antagonists in rheumatoid arthritis: a systematic review and meta-analysis.
Rheumatoid arthritis patients have a high level of pro-inflammatory interleukin-1. Augmenting the blockade of interleukin-1 receptors by external interleukin-1 receptor antagonist modifies the progression of the disease.
Added 5 days ago
BSR and BHPR guideline for the prescription and monitoring of non-biologic disease-modifying anti-rheumatic drugs
The purpose of this guideline is to provide up-to-date, evidence-based recommendations for the safe use of non-biologic DMARDs in adults (>16 years old).
Added 2 months ago
The task force aimed to: (1) develop evidence-based recommendations for patient education (PE) for people with inflammatory arthritis, (2) identify the need for further research on PE and (3) determine health professionals’ educational needs...
Added 3 years ago
These guidelines offer systematic and evidence-based recommendations for the prescription of anti-TNF therapies in adult PsA patients to support UK clinicians in their use.
Added 5 years ago
|Agency product number||EMEA/H/C/004192|
|Date First Approved||23-06-2017|
|Type||Medicinal product subject to restricted medical prescription|
|Marketing authorisation holder||Sandoz GmbH|