Indications: with moderate to severe active rheumatoid arthritis when response to disease-modifying antirheumatic drugs (including methotrexate) has been inadequate can be used in combination with methotrexate, or as a monotherapy if methotrexate is not tolerated or is contra-indicated. also licensed for : the treatment of severe active ankylosing spondylitis in patients who have had an inadequate response to, or are intolerant of NSAIDs. It is also licensed for the treatment of severe active axial spondyloarthritis, without radiographic evidence of ankylosing spondylitis but with objective signs of inflammation, in patients who have had an inadequate response to, or are intolerant of NSAIDs.

Cautions: predisposition to infection: monitor for infection before, during, and for 5 months after treatment. Do not initiate until active infections are controlled: discontinue if new serious infection develops until infection controlled. hepatitis B virus: monitor for active infection. Mild heart failure (discontinue if symptoms develop or worsen (avoid in moderate to severe heart failure). demyelinating CNS disorders (risk of exacerbation). History or development of malignancy; Tuberculosis Patients should be evaluated for tuberculosis before treatment. Active tuberculosis should be treated with standard treatment for at least 2 months before starting certolizumab pegol. Patients who have previously received adequate treatment for tuberculosis can start certolizumab pegol but should be monitored every 3 months for possible recurrence. In patients without active tuberculosis but who were previously not treated adequately, chemoprophylaxis should ideally be completed before starting certolizumab pegol. In patients at high risk of tuberculosis who cannot be assessed by tuberculin skin test, chemoprophylaxis can be given concurrently with certolizumab pegol. Patients should be advised to seek medical attention if symptoms suggestive of tuberculosis (e.g. persistent cough, weight loss, and fever) develop.

Blood disorders Patients should be advised to seek medical attention if symptoms suggestive of blood disorders (such as fever, sore throat, bruising, or bleeding) develop.

Contra-indications: severe active infection Pregnancy: avoid (manufacturer advises adequate contraception during treatment and for at least 5 months after last dose).

Breast-feeding; manufacturer advises use only if potential benefit outweighs risk (no information available).

Side Effects: hypertension, sensory abnormalities, rash; less commonly ascites, cholestasis, gastro-intestinal disorders (including perforation and ulcer), hepatic disorders, appetite disorders, cardiomyopathies (including heart failure), dyslipidaemia, syncope, oedema, dizziness, ischaemic coronary artery disorders, arrhythmias, asthma, pleural effusion, cough, peripheral neuropathy, tremor, anxiety, mood disorders, influenza-like illness, menstrual disorders, renal impairment, haematuria, malignancy (including solid tumours, lymphoma, and leukaemia), skin cancer, benign tumours, haemorrhage, electrolyte disorders, muscle disorders, visual disturbance, ocular inflammation, tinnitus, ecchymosis, impaired healing, alopecia, photosensitivity, acne, skin discoloration, nail disorders, new onset or worsening psoriasis, dermatitis; rarely cholelithiasis, splenomegaly, atrioventricular block, cerebrovascular accident, Raynaud's phenomenon, interstitial lung disease, impaired coordination, trigeminal neuralgia, seizures, thyroid disorders, sexual dysfunction, nephropathy. also reported multiple sclerosis.

Dose: By subcutaneous injection, rheumatoid arthritis, ADULT over 18 years: 400 mg, repeated 2 weeks and 4 weeks after initial injection, then 200 mg every 2 weeks (review treatment if no response within 12 weeks) Severe ankylosing spondylitis: severe axial spondyloarthritis, ADULT over 18 years: 400 mg, repeated 2 weeks and 4 weeks after initial injection, then 200 mg every 2 weeks or 400 mg every 4 weeks. review treatment if no response within 12 weeks.