Certolizumab pegol
Also known as: CDP870, certolizumab, Certolizumab pegol, Cimzia, RN777
Source Certolizumab pegol at Peptiology
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Summary
Certolizumab pegol is a PEGylated Fab' fragment that binds and neutralises tumour necrosis factor‑alpha (TNF‑α). It is an approved prescription biologic used primarily for inflammatory rheumatic diseases such as psoriatic arthritis and rheumatoid arthritis, where it reduces joint inflammation, pain and improves function and quality of life.
Mechanism of Action
The drug consists of a single‑chain antibody fragment (Fab') linked to polyethylene glycol, which prolongs its circulating half‑life. By binding soluble TNF‑α with high affinity, it prevents TNF‑α from engaging its cellular receptors (TNFR1 and TNFR2), thereby blocking downstream signalling pathways that drive cytokine release, leukocyte recruitment and tissue destruction in autoimmune inflammation.
What the Research Shows
Systematic literature reviews underpinning the 2022 and 2023 EULAR recommendations identified certolizumab pegol among the TNF inhibitors that consistently improved signs, symptoms, physical function and quality of life in rheumatoid arthritis and psoriatic arthritis trials. Safety data from observational studies and long‑term follow‑ups were aligned with the class‑wide profile, highlighting infections and other adverse events of interest. In a 2021 network meta‑analysis of Crohn's disease, certolizumab pegol showed lower odds of inducing remission compared with infliximab or adalimumab, suggesting modest efficacy in that setting.
Reported Benefits
Clinical trial evidence demonstrates that certolizumab pegol reduces disease activity scores, joint swelling and pain, and enhances functional ability in both rheumatoid arthritis and psoriatic arthritis. Patients also report better health‑related quality of life. Its PEGylated structure permits less frequent dosing than some alternatives, supporting adherence. The safety profile mirrors other TNF blockers, with no unique toxicities reported in the reviewed literature.
Limitations of the Evidence
Head‑to‑head comparisons are limited; most data are from separate trials rather than direct comparative studies. In Crohn's disease, network meta‑analysis suggests inferior remission rates versus other TNF inhibitors, indicating that it may not be the optimal first‑line biologic for that condition. Long‑term safety data rely on observational registries, which can be confounded by disease severity and concomitant therapies. Evidence outside rheumatology remains sparse.
Safety Considerations
Adverse events of special interest reported across studies include serious infections (e.g., tuberculosis, herpes zoster), malignancies, major cardiovascular events, and laboratory abnormalities. The overall incidence appears comparable to other TNF inhibitors. Clinicians should screen for latent infections before initiation and monitor for signs of infection or other complications during treatment. No new safety signals specific to certolizumab pegol were identified in the reviewed literature.
How It Is Administered
Certolizumab pegol is administered by injection, most commonly subcutaneously, using a pre‑filled syringe or autoinjector. The formulation is a PEGylated Fab' fragment, allowing for extended dosing intervals (typically every two to four weeks). Intravenous administration is listed but not commonly used in clinical practice.
Routes of Administration
Goals & Uses
- Ankylosing spondylitisAutoimmune DiseaseHigh
- Rheumatoid arthritis disease activity reductionRheumatologyHigh
- Ulcerative colitisGastrointestinalModerate
- Psoriatic arthritisAutoimmune DiseaseHigh
- Rheumatoid arthritisAutoimmune DiseaseHigh
- Ankylosing spondylitis and non-radiographic axial spondyloarthritis treatmentRheumatologyHigh
- Moderate-to-severe plaque psoriasisDermatologyHigh
- Crohn's disease remission induction and maintenanceGastroenterologyHigh
- Psoriatic arthritis symptom controlRheumatologyHigh
- Pregnancy-compatible anti-TNF therapyObstetrics/RheumatologyModerate
- Crohn's diseaseGastrointestinalHigh
Contraindications
- Hypersensitivity to certolizumab pegol or excipientsAllergy/ImmunologyHigh
- Moderate-to-severe heart failure (NYHA class III/IV)CardiovascularHigh
- Active tuberculosis or other severe infectionsInfectious DiseaseHigh
- Severe active infectionsInfectionHigh
- Hypersensitivity to certolizumab pegol or PEGAllergyHigh
- Demyelinating disordersNeurologyModerate
- Active tuberculosisInfectiousHigh
- Active hepatitis B infectionInfectious DiseaseHigh
Adverse Effects
- Pregnancy complicationsReproductiveUnknown
- Injection site reactionsLocalCommon
- Hypersensitivity/anaphylaxisImmunologicalRare
- Malignancies (lymphoma, solid tumors)OncologicRare
- Upper respiratory tract infectionsInfectious DiseaseCommon
- Autoimmune reactions (drug-induced lupus, autoantibody formation)ImmunologicUncommon
- Headache and nasopharyngitisGeneral/RespiratoryCommon
- Serious infections (e.g., pneumonia, sepsis)InfectiousUncommon
- Malignancies (e.g., lymphoma, skin cancer)OncologicRare
- Serious infections (bacterial, fungal, viral, opportunistic)InfectiousUncommon
Drug Interactions
- Other biologic DMARDs (e.g., rituximab, tocilizumab)Moderate
- AnakinraHigh
- Live vaccinesHigh
- CorticosteroidsModerate
- Other immunosuppressants (e.g., methotrexate, azathioprine)Moderate
- AbataceptHigh
- MethotrexateLow
Population Constraints
- PregnancyReproductive SafetyRelative
- Pediatric patients (<18 years)AgeRelative
- Pediatric patients (<18 y)AgeRelative
- Immunocompromised patientsImmunologicRelative
- Elderly patientsAgeRelative
- Patients with latent tuberculosisInfectious DiseaseRelative
- BreastfeedingReproductiveRelative
Regulatory Status
- European UnionApprovedApproved: Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Crohn's disease, Ulcerative colitisEMA approval 2009.
- United StatesApprovedApproved: Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Crohn's disease, Ulcerative colitisFDA approval 2010; marketed as Cimzia.
- United KingdomApprovedApproved: Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Crohn's disease, Ulcerative colitisMHRA approval aligned with EU.
Approved in the US (2010), EU (2009), and UK for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and ulcerative colitis. Marketed under the brand name Cimzia.
Evidence & Sources
- Journal ArticleHighKerschbaumer A, et al.2024-01-01T00:00:00.000000Z
- Journal ArticleHighKerschbaumer A, et al.2023-01-01T00:00:00.000000Z
- Journal ArticleModerateTokuyama M, Mabuchi T2020-01-01T00:00:00.000000Z
- Journal ArticleModerateBaumgart DC, Sandborn WJ2007-01-01T00:00:00.000000Z
- Journal ArticleHighSingh S, et al.2021-01-01T00:00:00.000000Z
- Journal ArticleLowSmolen JS, et al.2026-01-01T00:00:00.000000Z
Frequently Asked Questions
What conditions is certolizumab pegol approved to treat?
It is approved for rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. It is not approved for Crohn's disease or ulcerative colitis, although it has been studied in those conditions.
How does the PEGylation affect the drug?
PEGylation attaches a polyethylene‑glycol chain to the Fab fragment, increasing its molecular size and reducing renal clearance, which prolongs the drug’s half‑life and allows less frequent dosing.
What are the main safety concerns?
The main concerns are infections, including reactivation of latent tuberculosis, opportunistic infections such as herpes zoster, and the usual class‑related risks of malignancy and cardiovascular events. Patients should be screened and monitored accordingly.
Can certolizumab pegol be used during pregnancy?
The literature reviewed does not address pregnancy safety. Current prescribing information recommends a risk‑benefit assessment and consultation with a specialist before use in pregnancy.
How quickly does it work?
Clinical trials report improvements in joint symptoms within several weeks of starting therapy, with maximal benefit typically observed after 12‑16 weeks of regular dosing.
What is Certolizumab pegol?
Certolizumab pegol is a PEGylated Fab' fragment that binds and neutralises tumour necrosis factor‑alpha (TNF‑α). It is an approved prescription biologic used primarily for inflammatory rheumatic diseases such as psoriatic arthritis and rheumatoid arthritis, where it reduces joint inflammation, pain and improves function and quality of life.
What is Certolizumab pegol used for?
Certolizumab pegol is educationally associated with: Ankylosing spondylitis, Rheumatoid arthritis disease activity reduction, Ulcerative colitis, Psoriatic arthritis, Rheumatoid arthritis, Ankylosing spondylitis and non-radiographic axial spondyloarthritis treatment, Moderate-to-severe plaque psoriasis, Crohn's disease remission induction and maintenance, Psoriatic arthritis symptom control, Pregnancy-compatible anti-TNF therapy, Crohn's disease. Educational only — not medical advice.
How is Certolizumab pegol administered?
Recorded routes of administration: Intravenous, Subcutaneous.
What are the potential side effects of Certolizumab pegol?
Reported adverse effects include: Pregnancy complications, Injection site reactions, Hypersensitivity/anaphylaxis, Malignancies (lymphoma, solid tumors), Upper respiratory tract infections, Autoimmune reactions (drug-induced lupus, autoantibody formation), Headache and nasopharyngitis, Serious infections (e.g., pneumonia, sepsis), Malignancies (e.g., lymphoma, skin cancer), Serious infections (bacterial, fungal, viral, opportunistic). This list is not exhaustive — consult a qualified clinician.
Who should avoid Certolizumab pegol?
Recorded contraindications: Hypersensitivity to certolizumab pegol or excipients, Moderate-to-severe heart failure (NYHA class III/IV), Active tuberculosis or other severe infections, Severe active infections, Hypersensitivity to certolizumab pegol or PEG, Demyelinating disorders, Active tuberculosis, Active hepatitis B infection. Consult a qualified clinician before use.