Cimzia: Uses, Dosage & Side Effects
A PEGylated anti-TNF Fab' fragment for the treatment of rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, and plaque psoriasis in adults
Cimzia (certolizumab pegol) is a prescription biologic medication classified as a tumour necrosis factor (TNF) inhibitor. It is used to treat several chronic inflammatory conditions in adults, including moderate to severe rheumatoid arthritis, axial spondyloarthritis (including ankylosing spondylitis), psoriatic arthritis, and moderate to severe plaque psoriasis. Cimzia is unique among TNF inhibitors because it consists of a PEGylated Fab' fragment rather than a complete antibody, which means it lacks the Fc region and does not actively cross the placenta. It is administered as a subcutaneous injection using a pre-filled pen (AutoClicks), with a typical loading dose of 400 mg at weeks 0, 2, and 4, followed by a maintenance dose of 200 mg every two weeks.
Quick Facts: Cimzia
Key Takeaways
- Cimzia (certolizumab pegol) is a PEGylated Fab' fragment TNF inhibitor approved for rheumatoid arthritis, axial spondyloarthritis (including ankylosing spondylitis), psoriatic arthritis, and moderate to severe plaque psoriasis in adults.
- Unlike other TNF inhibitors, Cimzia lacks the Fc region, which means it does not fix complement, does not cause antibody-dependent cell-mediated cytotoxicity, and has minimal to no active placental transfer – making it a consideration for women of childbearing potential.
- The standard loading dose is 400 mg (two injections of 200 mg) at weeks 0, 2, and 4, followed by a maintenance dose of 200 mg every 2 weeks or 400 mg every 4 weeks, depending on the condition and clinical response.
- Tuberculosis screening is mandatory before starting treatment. Patients must be monitored for serious infections, heart failure, lymphoma, and other malignancies during therapy.
- Cimzia is self-administered at home using a pre-filled pen (AutoClicks) after proper training, and should be stored refrigerated (2–8 °C) but can be kept at room temperature (up to 25 °C) for a single period of up to 10 days.
What Is Cimzia and What Is It Used For?
Cimzia contains the active substance certolizumab pegol, which is a PEGylated Fab' fragment of a humanized monoclonal antibody. Unlike conventional anti-TNF biologics that consist of complete immunoglobulin G (IgG) antibodies, certolizumab pegol is composed only of the antigen-binding fragment (Fab') of an antibody, conjugated to a 40-kDa polyethylene glycol (PEG) moiety. This unique molecular architecture is what distinguishes Cimzia from all other TNF inhibitors on the market, including adalimumab (Humira), infliximab (Remicade), etanercept (Enbrel), and golimumab (Simponi).
Tumour necrosis factor alpha (TNF-alpha) is a pro-inflammatory cytokine produced primarily by activated macrophages, T cells, and other immune cells. It plays a central role in the pathogenesis of several chronic inflammatory and autoimmune diseases. In rheumatoid arthritis, TNF-alpha drives synovial inflammation, joint destruction, and cartilage degradation. In axial spondyloarthritis, it contributes to spinal inflammation and progressive structural damage. In psoriasis and psoriatic arthritis, TNF-alpha perpetuates the cycle of keratinocyte proliferation, immune cell recruitment, and joint inflammation.
Certolizumab pegol binds with high affinity and specificity to soluble and membrane-bound TNF-alpha, effectively neutralizing its biological activity. The PEGylation serves two critical purposes: it extends the plasma half-life of the Fab' fragment to approximately 14 days (comparable to a full IgG antibody), and it increases the hydrodynamic size of the molecule, reducing renal clearance. The absence of the Fc (crystallizable fragment) region has several important clinical implications. First, certolizumab pegol does not fix complement and does not induce antibody-dependent cell-mediated cytotoxicity (ADCC) or complement-dependent cytotoxicity (CDC). Second, and perhaps most significantly for clinical practice, the lack of an Fc region means that certolizumab pegol does not bind to the neonatal Fc receptor (FcRn), which is responsible for the active transplacental transfer of IgG antibodies. Clinical studies have confirmed minimal to no placental transfer of certolizumab pegol, making it a unique option for women of childbearing potential who require TNF inhibitor therapy.
Cimzia is approved for use in adults with the following inflammatory conditions:
- Rheumatoid arthritis (RA): For the treatment of moderate to severe active RA in adult patients who have had an inadequate response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate. Cimzia is used in combination with methotrexate, or as monotherapy when methotrexate is inappropriate. It can also be used in combination with methotrexate for severe, active, and progressive RA in DMARD-naive patients. In clinical trials (RAPID 1 and RAPID 2), certolizumab pegol in combination with methotrexate demonstrated significant improvements in ACR20, ACR50, and ACR70 response rates, as well as inhibition of radiographic progression and improvement in physical function.
- Axial spondyloarthritis (axSpA): Including ankylosing spondylitis (AS, also known as radiographic axial spondyloarthritis) and non-radiographic axial spondyloarthritis (nr-axSpA). Cimzia is indicated for adults with severe active disease who have had an inadequate response to, or are intolerant of, nonsteroidal anti-inflammatory drugs (NSAIDs). The RAPID-axSpA trial demonstrated significant improvements in ASAS20 and ASAS40 response rates, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and physical function.
- Psoriatic arthritis (PsA): For the treatment of active PsA in adults who have had an inadequate response to DMARDs. Cimzia is used in combination with methotrexate or as monotherapy when methotrexate is inappropriate. The RAPID-PsA trial showed significant improvements in joint and skin manifestations, physical function, and quality of life.
- Plaque psoriasis: For the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. The CIMPASI-1, CIMPASI-2, and CIMPACT-55 trials demonstrated significant improvements in Psoriasis Area and Severity Index (PASI) 75, PASI 90, and Physician Global Assessment (PGA) clear or almost clear responses.
Cimzia is the only TNF inhibitor that is a PEGylated Fab' fragment rather than a complete antibody. This structural difference means it does not have an Fc region, so it does not fix complement, does not cause ADCC, and critically, does not actively cross the placenta via FcRn-mediated transport. The CRIB and CRADLE studies demonstrated minimal to no placental transfer of certolizumab pegol, and the drug was below the limit of quantification in the vast majority of infant blood samples at birth. This makes Cimzia an important therapeutic option for women who need anti-TNF therapy during their reproductive years.
What Should You Know Before Taking Cimzia?
Contraindications
Cimzia is contraindicated in patients with known hypersensitivity to certolizumab pegol or to any of the excipients (sodium acetate, sodium chloride, and water for injections). Serious allergic reactions including anaphylaxis have been reported. If you experience symptoms such as chest tightness, wheezing, dizziness, swelling of the face, lips, tongue, or throat, or widespread rash after receiving Cimzia, stop using the medication and seek immediate medical attention.
Cimzia must not be used in patients with active tuberculosis (TB) or other severe active infections such as sepsis, abscesses, or opportunistic infections. It is also contraindicated in patients with moderate to severe heart failure (New York Heart Association class III/IV). If you have or have had a serious heart condition, inform your doctor before starting treatment.
Allergy to certolizumab pegol or any excipient; active tuberculosis or other severe infections; moderate to severe heart failure (NYHA class III/IV). If any of these apply, discuss alternative treatments with your doctor immediately.
Warnings and Precautions
Before and during treatment with Cimzia, your doctor will monitor you carefully for several important safety concerns. TNF inhibitors, including certolizumab pegol, affect the immune system and can increase the risk of certain conditions:
- Serious infections: Cimzia suppresses part of the immune system, which means you may be more susceptible to infections, including serious or life-threatening infections. Bacterial infections, viral infections (including herpes zoster/shingles and influenza), fungal infections (including histoplasmosis, coccidioidomycosis, and candidiasis), and opportunistic infections have all been reported. If you develop symptoms of infection such as fever, persistent cough, weight loss, fatigue, or wounds that do not heal, contact your doctor immediately.
- Tuberculosis (TB): Cases of active tuberculosis, including reactivation of latent TB and new-onset TB, have been reported in patients receiving Cimzia. Your doctor must screen you for TB before starting treatment, including a thorough medical history, chest X-ray, and tuberculin skin test or interferon-gamma release assay. If latent TB is detected, you must receive appropriate anti-TB prophylaxis before starting Cimzia. Even with preventive treatment, TB can develop during therapy, so report any persistent cough, weight loss, fatigue, or low-grade fever immediately.
- Hepatitis B virus (HBV): Cimzia may increase the risk of HBV reactivation in chronic carriers. Your doctor should test for HBV infection before initiating treatment. If reactivation occurs, Cimzia should be discontinued and appropriate antiviral therapy initiated.
- Heart failure: If you have mild heart failure (NYHA class I/II), your condition must be closely monitored. New or worsening symptoms of heart failure (shortness of breath, swelling of the feet or ankles) should be reported to your doctor immediately. Treatment may need to be discontinued.
- Malignancies: An increased risk of certain cancers, including lymphoma, has been observed in patients treated with TNF inhibitors. Patients with severe, long-standing rheumatoid arthritis may already have an elevated baseline risk of lymphoma. Non-melanoma skin cancers have also been reported. Report any new skin lesions or changes in existing lesions to your doctor. Cases of cancer in children and adolescents treated with TNF inhibitors have been reported, which is one reason Cimzia is not recommended for patients under 18 years of age.
- Demyelinating diseases: TNF inhibitors have been associated with rare cases of new onset or exacerbation of central nervous system demyelinating diseases, including multiple sclerosis and Guillain-Barré syndrome. If you have a pre-existing neurological condition such as multiple sclerosis, your doctor will carefully evaluate whether Cimzia is appropriate for you.
- Blood disorders: Rarely, TNF inhibitors can cause pancytopenia (low counts of all blood cell types). If you develop persistent fever, bruising, bleeding, or unusual pallor, contact your doctor immediately.
- Lupus-like syndrome: Uncommonly, patients on TNF inhibitors may develop symptoms resembling systemic lupus erythematosus, including persistent rash, fever, joint pain, and fatigue. If these symptoms develop, your doctor may discontinue Cimzia.
Vaccinations
Discuss your vaccination status with your doctor before starting Cimzia. You should not receive live vaccines during treatment, as the immunosuppressive effect of Cimzia may increase the risk of infection from live attenuated vaccines. Inactivated vaccines (such as the annual influenza vaccine) can generally be administered during treatment. If you received Cimzia during pregnancy, your infant may have an increased risk of infection from live vaccines for approximately five months after your last dose during pregnancy. Inform your child's paediatrician about your Cimzia use so that the vaccination schedule can be appropriately planned.
Pregnancy and Breastfeeding
Cimzia has a unique profile among TNF inhibitors with respect to pregnancy. Because it lacks the Fc region, certolizumab pegol does not actively cross the placenta via FcRn-mediated transport. The CRIB study measured certolizumab pegol levels in maternal blood and infant blood at delivery and found that the drug was below the limit of quantification in 13 out of 14 infant blood samples. The CRADLE study further confirmed that certolizumab pegol transfer into breast milk was minimal to undetectable. Based on these data, professional bodies including EULAR have recognized Cimzia as compatible with use during pregnancy and breastfeeding when clinically indicated.
Nevertheless, Cimzia should only be used during pregnancy when clearly necessary, as determined by the treating physician. Women of childbearing potential should discuss effective contraception with their doctor. If discontinuing Cimzia before a planned pregnancy, contraception may be considered for up to 5 months after the last dose. Cimzia may be used during breastfeeding.
Children and Adolescents
Cimzia is not recommended for use in children and adolescents under 18 years of age. The safety and efficacy of certolizumab pegol have not been established in paediatric patients.
Driving and Operating Machinery
Cimzia may have a minor effect on your ability to drive and operate machinery. Dizziness (including vertigo), blurred vision, and fatigue may occur after injection. If you experience any of these symptoms, refrain from driving or operating machinery until they resolve.
How Does Cimzia Interact with Other Drugs?
As a biologic medicine (a PEGylated Fab' antibody fragment), certolizumab pegol is not metabolized by cytochrome P450 (CYP) enzymes in the liver. This means that traditional drug-drug interactions based on hepatic enzyme inhibition or induction do not apply to Cimzia. However, there are important pharmacodynamic interactions related to the immunosuppressive mechanism of the drug that must be considered.
The most clinically significant interactions involve other biologic immunomodulators that also suppress the immune system. Combining Cimzia with these agents can lead to additive immunosuppression and a substantially increased risk of serious infections:
Major Interactions (Contraindicated Combinations)
| Drug | Class | Risk | Recommendation |
|---|---|---|---|
| Anakinra | IL-1 receptor antagonist | Markedly increased risk of serious infections with no added clinical benefit | Do not use together |
| Abatacept | T-cell co-stimulation modulator | Increased risk of serious infections including tuberculosis | Do not use together |
| Live vaccines | Vaccines (BCG, MMR, varicella, etc.) | Risk of vaccine-related infection due to immunosuppression | Do not administer during treatment |
Compatible Medications
Cimzia can be safely used alongside several categories of medications commonly prescribed for inflammatory and autoimmune conditions. In clinical trials, the following concomitant medications were used without evidence of clinically significant interactions:
| Drug Category | Examples | Interaction Status |
|---|---|---|
| Methotrexate | Oral or subcutaneous methotrexate | Recommended combination for RA and PsA |
| Corticosteroids | Prednisolone, methylprednisolone | No interaction identified |
| NSAIDs | Ibuprofen, naproxen, diclofenac | No interaction identified |
| Analgesics | Paracetamol, codeine | No interaction identified |
| Inactivated vaccines | Influenza, pneumococcal, COVID-19 | Can be administered during treatment |
It is important to note that while methotrexate is frequently used in combination with Cimzia for rheumatoid arthritis and psoriatic arthritis, population pharmacokinetic analyses have shown that methotrexate does not significantly alter the pharmacokinetics of certolizumab pegol. However, concomitant methotrexate use may reduce the formation of anti-drug antibodies, potentially improving the long-term efficacy of Cimzia. Always inform your doctor about all medications you are taking, including over-the-counter drugs and herbal supplements.
What Is the Correct Dosage of Cimzia?
Adults
Cimzia dosing follows a loading-dose regimen to rapidly achieve therapeutic drug levels, followed by ongoing maintenance dosing. The specific maintenance regimen depends on the condition being treated and the clinical response. All doses are given by subcutaneous injection, typically in the thigh or abdomen.
Rheumatoid Arthritis
Loading dose: 400 mg (two 200 mg injections) at weeks 0, 2, and 4.
Maintenance dose: 200 mg every 2 weeks. If the patient responds, an alternative maintenance dose of 400 mg every 4 weeks may be considered.
Concomitant therapy: Methotrexate should be continued during Cimzia treatment. If methotrexate is deemed inappropriate, Cimzia can be given as monotherapy.
Axial Spondyloarthritis (Ankylosing Spondylitis and nr-axSpA)
Loading dose: 400 mg (two 200 mg injections) at weeks 0, 2, and 4.
Maintenance dose: 200 mg every 2 weeks (from week 6) or 400 mg every 4 weeks (from week 8), as directed by your doctor.
Dose reduction: In patients who have been on Cimzia for at least one year and show a sustained clinical response, a reduced maintenance dose of 200 mg every 4 weeks may be considered.
Psoriatic Arthritis
Loading dose: 400 mg (two 200 mg injections) at weeks 0, 2, and 4.
Maintenance dose: 200 mg every 2 weeks. If the patient responds, an alternative maintenance dose of 400 mg every 4 weeks may be considered.
Concomitant therapy: Methotrexate should be continued where appropriate. Cimzia can be given as monotherapy when methotrexate is inappropriate.
Plaque Psoriasis
Loading dose: 400 mg (two 200 mg injections) every 2 weeks at weeks 0, 2, and 4.
Maintenance dose: 200 mg every 2 weeks or 400 mg every 2 weeks, as directed by your doctor.
How Cimzia Is Administered
Cimzia is given as a subcutaneous injection using the pre-filled AutoClicks pen. The injection is usually given in the thigh or abdomen. Do not inject into areas where the skin is red, hard, or bruised. Each new injection should be given at a different site from the previous one. After initial administration by a healthcare professional and proper training, patients can self-inject at home.
Follow-up with your doctor is recommended after 12 weeks (for RA, axSpA, or PsA) or after 16 weeks (for plaque psoriasis) to assess whether Cimzia is working adequately or whether alternative treatment should be considered.
Missed Dose
If you forget to give yourself an injection, administer the next dose of Cimzia as soon as you remember. Then contact your doctor and follow their instructions for subsequent doses. Do not inject a double dose to make up for a missed injection.
Overdose
If you accidentally inject Cimzia more frequently than prescribed, contact your doctor immediately. In clinical trials, no dose-limiting toxicity was identified. The maximum tolerated dose has not been formally established, but single intravenous doses of up to 800 mg and weekly subcutaneous doses of up to 400 mg have been administered without significant dose-limiting adverse effects. There is no specific antidote for certolizumab pegol overdose. Treatment is supportive.
Stopping Treatment
Do not stop using Cimzia without first speaking to your doctor, even if you feel better. Discontinuing treatment without medical guidance may lead to a flare of your underlying condition. Your doctor will advise you on when it is appropriate to stop or modify your treatment.
What Are the Side Effects of Cimzia?
Like all medicines, Cimzia can cause side effects, although not everyone experiences them. Because Cimzia works by suppressing part of the immune system (specifically TNF-alpha), many of the side effects are related to increased susceptibility to infections and immune-mediated conditions. The side effects are classified below by frequency according to international pharmacovigilance conventions.
Severe rash, hives, or signs of allergic reaction (urticaria); swelling of face, hands, or feet (angioedema); difficulty breathing or swallowing; shortness of breath when exerting yourself or lying down, or swollen feet (heart failure); symptoms of blood disorders such as persistent fever, bruising, bleeding, or unusual pallor; severe skin reactions that look like red-purple target-shaped spots with blisters, peeling skin, or sores in the mouth (Stevens-Johnson syndrome).
Common Side Effects
May affect up to 1 in 10 people
- Bacterial infections at any site (abscesses)
- Viral infections (cold sores, shingles, influenza)
- Fever
- High blood pressure (hypertension)
- Rash or itching
- Headache (including migraine)
- Sensory disturbances (numbness, tingling, burning)
- Weakness and general malaise
- Pain
- Blood disorders
- Liver problems
- Injection site reactions
- Nausea
Uncommon Side Effects
May affect up to 1 in 100 people
- Allergic reactions including anaphylaxis, allergic rhinitis
- Autoantibodies (antibodies directed against normal body tissue)
- Lymphoma, leukaemia, and solid organ cancers
- Skin cancer (non-melanoma), pre-cancerous skin changes
- Heart problems (weakened heart muscle, heart failure, heart attack, chest discomfort, irregular heartbeat)
- Oedema (swelling of face or legs)
- Lupus-like symptoms (joint pain, skin rash, photosensitivity, fever)
- Blood vessel inflammation (vasculitis)
- Sepsis (blood poisoning)
- Tuberculosis infection
- Fungal infections
- Respiratory disorders (asthma, shortness of breath, cough, pleurisy)
- Gastrointestinal problems (fluid in the abdomen, ulcers, perforation, bloating, heartburn)
- Gallbladder problems
- Muscle problems including elevated muscle enzymes
- Blood clots in veins or lungs
- Changes in blood cell counts (anaemia, low or high platelet count)
- Swollen lymph nodes
- Flu-like symptoms, chills, night sweats, flushing
- Anxiety and mood changes (depression, appetite disorders, weight changes)
- Tinnitus (ringing in the ears)
- Vertigo (dizziness)
- Fainting or loss of consciousness
- Nerve disorders in arms and legs (numbness, tingling, tremors)
- Skin disorders (new or worsened psoriasis, eczema, sweat gland disorders, ulcers, photosensitivity, acne, hair loss, nail separation, dry skin)
- Impaired wound healing
- Kidney and urinary problems (decreased kidney function, blood in urine)
- Menstrual irregularities
- Eye inflammation, vision disturbances, tear production problems
- Prolonged blood clotting time
Rare Side Effects
May affect up to 1 in 1,000 people
- Gastrointestinal cancer, melanoma
- Interstitial lung disease, pneumonitis
- Stroke, atherosclerosis, Raynaud's phenomenon
- Pericarditis (inflammation of the heart lining)
- Cardiac arrhythmia
- Enlarged spleen
- Increased red blood cell count, abnormal white blood cell appearance
- Gallstones
- Kidney problems (including nephritis)
- Immune system disorders (sarcoidosis, serum sickness)
- Thyroid disorders (goitre, fatigue, weight loss)
- Suicide attempt, decreased mental function, delirium
- Cranial nerve inflammation (auditory, optic, facial nerve)
- Fistulas (abnormal channels between organs)
- Skin blistering, Stevens-Johnson syndrome, erythema multiforme
- Seizures
- Worsening of dermatomyositis
- Lichenoid reactions (itchy red-purple skin rash)
Not Known (Frequency Cannot Be Estimated)
Reported from post-marketing surveillance
- Multiple sclerosis
- Guillain-Barré syndrome
- Merkel cell carcinoma (a type of skin cancer)
- Kaposi's sarcoma (a cancer associated with human herpesvirus 8, appearing as purple skin patches)
If you experience any side effects, especially those not listed above, report them to your healthcare provider. You can also report suspected side effects directly to your national medicines regulatory authority (such as the FDA MedWatch program in the US, the MHRA Yellow Card Scheme in the UK, or the EMA in the EU). Reporting side effects helps to provide more information on the safety of this medicine.
How Should You Store Cimzia?
Proper storage of Cimzia is essential to maintain the stability and effectiveness of the medication. The pre-filled AutoClicks pens must be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze Cimzia at any time, as freezing will damage the protein structure of certolizumab pegol and render the medication ineffective. Keep the pens in the original outer carton to protect them from light exposure, which can degrade the active substance.
For convenience, the pre-filled pens may be removed from the refrigerator and stored at room temperature (up to 25°C / 77°F) for a single continuous period of up to 10 days, provided they are protected from light. At the end of this 10-day period, the pens must either be used or discarded. Do not return them to the refrigerator after room temperature storage.
Before each injection, allow the pen to reach room temperature for 30 to 45 minutes. Do not attempt to warm it by any other means (such as hot water or microwave). Before use, inspect the solution through the pen's viewing window. The solution should be clear to opalescent and colourless to yellow. Do not use the medication if the solution is discoloured, cloudy, or contains visible particles. Small air bubbles in the solution are normal and do not affect the safety or efficacy of the injection.
Keep Cimzia out of the sight and reach of children. Do not use the medication after the expiry date printed on the carton and pen label. The expiry date refers to the last day of that month. Dispose of used pens in a sharps disposal container as directed by your healthcare provider. Do not dispose of medicines in wastewater or household waste.
What Does Cimzia Contain?
The active substance in Cimzia is certolizumab pegol, a PEGylated Fab' fragment of a humanized anti-TNF monoclonal antibody. Each pre-filled AutoClicks pen contains 200 mg of certolizumab pegol dissolved in 1 mL of solution for injection. The molecular weight of certolizumab pegol is approximately 91 kDa, of which about 40 kDa is contributed by the PEG moiety.
The other ingredients (excipients) in Cimzia are:
- Sodium acetate: Acts as a buffer to maintain the pH of the solution
- Sodium chloride: Provides tonicity to the solution (making it isotonic with body fluids)
- Water for injections: The solvent
Cimzia contains less than 1 mmol (23 mg) of sodium per 400 mg dose, meaning it is essentially sodium-free. This is relevant for patients on a sodium-restricted diet.
Packaging
Cimzia is supplied as a solution for injection in pre-filled AutoClicks pens, ready to use. The solution is clear to opalescent and colourless to yellow. Each Cimzia pack contains 2 AutoClicks pre-filled pens and 2 alcohol swabs for cleansing the injection site. Multi-packs containing 6 pens (3 packs of 2) or 10 pens (5 packs of 2) with corresponding alcohol swabs are also available. Not all pack sizes may be marketed in every country.
The marketing authorisation holder is UCB Pharma S.A., Allée de la Recherche 60, B-1070 Brussels, Belgium. The manufacturer is UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium.
Frequently Asked Questions About Cimzia
Cimzia (certolizumab pegol) is a TNF inhibitor used to treat several chronic inflammatory conditions in adults: moderate to severe rheumatoid arthritis (usually in combination with methotrexate), axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), active psoriatic arthritis, and moderate to severe plaque psoriasis. It works by neutralizing TNF-alpha, a protein that drives inflammation in these conditions.
Cimzia is the only TNF inhibitor that consists of a PEGylated Fab' fragment rather than a complete antibody. This means it lacks the Fc region, so it does not fix complement, does not cause antibody-dependent cell-mediated cytotoxicity (ADCC), and critically, does not actively cross the placenta via FcRn-mediated transport. Clinical studies (CRIB and CRADLE) have confirmed minimal to no placental transfer, making it a unique option for women of childbearing potential who need anti-TNF therapy.
Cimzia has a favourable profile for use in pregnancy compared to other TNF inhibitors. Because it lacks the Fc region, it does not actively cross the placenta. The CRIB study showed that certolizumab pegol was below the limit of quantification in 13 out of 14 infant blood samples at birth. The CRADLE study confirmed minimal transfer into breast milk. EULAR recognizes Cimzia as compatible with pregnancy and breastfeeding when clinically indicated. Nevertheless, the decision to use Cimzia during pregnancy should be made in consultation with your doctor.
Yes, tuberculosis (TB) screening is mandatory before starting Cimzia. Your doctor will review your medical history, perform a chest X-ray, and conduct a tuberculin skin test or interferon-gamma release assay. If latent TB is detected, you must complete appropriate anti-TB prophylaxis before beginning Cimzia. TB can still develop during treatment, so report any persistent cough, weight loss, fatigue, or low-grade fever to your doctor immediately.
Cimzia has a loading-dose regimen (400 mg at weeks 0, 2, and 4) designed to achieve therapeutic drug levels quickly. In clinical trials for rheumatoid arthritis, significant improvements in ACR20 response were observed as early as week 1. For psoriasis, PASI improvements were typically seen within 4 to 8 weeks. Your doctor will formally evaluate your response after 12 weeks (for RA, axSpA, or PsA) or 16 weeks (for psoriasis) to decide whether to continue treatment.
Yes, after proper training by a healthcare professional, you can self-inject Cimzia at home using the pre-filled AutoClicks pen. The pen is designed for ease of use: remove the clear cap, press the pen firmly against your skin (thigh or abdomen) until you hear a first click, hold it in place until you hear a second click and the window turns orange (up to 15 seconds), and then remove. Always rotate injection sites and do not inject into red, hard, or bruised skin.
References
- European Medicines Agency (EMA). Cimzia Summary of Product Characteristics. Last updated 2025. Available at: ema.europa.eu/en/medicines/human/EPAR/cimzia
- U.S. Food and Drug Administration (FDA). Cimzia Prescribing Information. UCB, Inc. Revised 2024. Available at: accessdata.fda.gov
- Smolen JS, Landewé RBM, Bergstra SA, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023;82(1):3-18. doi:10.1136/ard-2022-223356
- Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res. 2021;73(7):924-939. doi:10.1002/acr.24596
- Mariette X, Förger F, Abraham B, et al. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis. 2018;77(2):228-233. doi:10.1136/annrheumdis-2017-212196
- Clowse MEB, Scheuerle AE, Engstrom Chambers E, et al. Pregnancy outcomes after exposure to certolizumab pegol: updated results from a pharmacovigilance safety database. Arthritis Rheumatol. 2018;70(9):1399-1407.
- Keystone E, Heijde D, Mason D Jr, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis (RAPID 1). Arthritis Rheum. 2008;58(11):3319-3329. doi:10.1002/art.23964
- Landewé R, Braun J, Deodhar A, et al. Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study (RAPID-axSpA). Ann Rheum Dis. 2014;73(1):39-47.
- Gottlieb AB, Blauvelt A, Thaçi D, et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2). J Am Acad Dermatol. 2018;79(2):302-314.e6.
- British Association of Dermatologists (BAD). Guidelines for Biologic Therapy for Psoriasis. 2023. Available at: bad.org.uk/guidelines
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, a group of licensed specialist physicians with expertise in rheumatology, immunology, dermatology, and clinical pharmacology.
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iMedic Medical Editorial Team
Board-certified physicians specializing in rheumatology, immunology, and clinical pharmacology with extensive clinical and research experience.
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