Certolizumab pegol
Also known as: Cimzia
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In short
In the European Union, certolizumab pegol is indicated for the treatment of moderate to severe, active rheumatoid arthritis in adults when response to disease-modifying antirheumatic drugs has been inadequate, and for severe, active, and progressive rheumatoid arthritis in adults not previously treated with methotrexate. In the European Union, it is also indicated for severe active axial spondyloarthritis in adults, including ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, when there has been an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs. In the United States, certolizumab pegol is indicated for reducing signs and symptoms and maintaining clinical response in adults with moderately to severely active Crohn's disease who had an inadequate response to conventional therapy, and for treating adults with moderately to severely active rheumatoid arthritis. Additionally, in the United States, it is indicated for active polyarticular juvenile idiopathic arthritis in patients aged 2 years and older, active psoriatic arthritis, active ankylosing spondylitis, active non-radiographic axial spondyloarthritis, and moderate-to-severe plaque psoriasis in candidates for systemic therapy or phototherapy.
From: Source: European Medicines Agency (EMA), Cimzia — EPAR, 19/05/2026. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration.
AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.
Codes
- RxNorm
- 709271 certolizumab pegol
- EMA
- EMEA/H/C/001037
Official indications
Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.
EMA (EU) Cimzia
Rheumatoid arthritis Cimzia, in combination with methotrexate (MTX), is indicated for: the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including MTX, has been inadequate. Cimzia can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs. Cimzia has been shown to reduce the rate of progression of joint damage as measured by X ray and to improve physical function, when given in combination with MTX. Axial spondyloarthritis Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising: Ankylosing spondylitis (AS) Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Axial spondyloarthritis without radiographic evidence of AS Adults with severe active axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated C reactive protein (CRP) and /or magnetic resonance imaging (MRI), who have had an inadequate response to, or are intolerant to NSAIDs. Psoriatic arthritis Cimzia, in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Source: European Medicines Agency (EMA), Cimzia — EPAR, 19/05/2026. © European Medicines Agency.
Document date: 19/05/2026 · Official document →
FDA (USA) Cimzia
1 INDICATIONS AND USAGE CIMZIA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy ( 1.1 ) Treatment of adults with moderately to severely active rheumatoid arthritis ( 1.2 ) Treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older ( 1.3 ) Treatment of adult patients with active psoriatic arthritis. ( 1.4 ) Treatment of adults with active ankylosing spondylitis ( 1.5 ) Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation ( 1.6 ) Treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy ( 1.7 ) 1.1 Crohn's Disease CIMZIA is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. 1.2 Rheumatoid Arthritis CIMZIA is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). 1.3 Polyarticular Juvenile Idiopathic Arthritis CIMZIA is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older. 1.4 Psoriatic Arthritis CIMZIA is indicated for the treatment of adult patients with active psoriatic arthritis (PsA). 1.5 Ankylosing Spondylitis CIMZIA is indicated for the treatment of adults with active ankylosing spondylitis (AS). [see Clinical Studies (14.5) ] 1.6 Non-radiographic Axial Spondyloarthritis CIMZIA is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation [see Clinical Studies (14.6) ]. 1.7 Plaque Psoriasis CIMZIA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy [see Clinical Studies (14.7) ]
Data provided by the U.S. Food and Drug Administration.
Document date: 20260224 · Official document →
Other treatments A–Z
What people report
Not enough data yet. Anonymous counts appear here only for groups of at least 20 people who agreed to share them.
External resources
Questions
What is Certolizumab pegol approved for in the European Union?
Rheumatoid arthritis Cimzia, in combination with methotrexate (MTX), is indicated for: the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including MTX, has been inadequate. Cimzia can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs. Cimzia has been shown to reduce the rate of progression of joint damage as measured by X ray and to improve physical function, when given in combination with MTX. Axial spondyloarthritis Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising: Ankylosing spondylitis (AS) Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Axial spondyloarthritis without radiographic evidence of AS Adults with severe active axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated C reactive protein (CRP) and /or magnetic resonance imaging (MRI), who have had an inadequate response to, or are intolerant to NSAIDs. Psoriatic arthritis Cimzia, in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. (Source: European Medicines Agency (EMA), Cimzia — EPAR, 19/05/2026. © European Medicines Agency.)
Sources and attribution
- Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
- Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
- Data provided by the U.S. Food and Drug Administration.
- This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
- Source: European Medicines Agency (EMA), Cimzia — EPAR, 19/05/2026. © European Medicines Agency.
Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →
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Treatments. Indications are quoted unchanged from official product information (European Medicines Agency, U.S. Food and Drug Administration). They describe what a medicine is approved for, not whether it is right for you. Approved uses can differ between countries. Always read the package leaflet and follow your doctor's or pharmacist's advice.
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