Certolizumab pegol

Therapeutic Indications

Certolizumab pegol is indicated for:

Psoriatic arthritis

Irrespective of gender only Adults (18 years old or older)

Certolizumab pegol, 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.

Certolizumab pegol can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - 200-400 mg once every 2 weeks

Plaque psoriasis

Irrespective of gender only Adults (18 years old or older)

Certolizumab pegol is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - 200-400 mg once every 2 weeks

Rheumatoid arthritis

Irrespective of gender only Adults (18 years old or older)

Certolizumab pegol, 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. Certolizumab pegol 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.

Certolizumab pegol 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.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - 200-400 mg once every 2 weeks

Axial spondyloarthritis

Irrespective of gender only Adults (18 years old or older)

Certolizumab pegol is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising:

Ankylosing spondylitis (AS) (also known as radiographic axial spondyloarthritis)

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 (also known as non-radiographic axial spondyloarthritis)

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.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - 200-400 mg once every 2 weeks

Contraindications

Active ingredient Certolizumab pegol is contraindicated in the following cases:

Moderate to severe heart failure (NYHA classes III/IV)

No gender/age discrimination

Certolizumab pegol is contraindicated in moderate or severe heart failure. In a clinical trial with another TNF antagonist, worsening congestive heart failure and increased mortality due to congestive heart failure have been observed. Cases of congestive heart failure have also been reported in rheumatoid arthritis patients receiving certolizumab pegol. Certolizumab pegol should be used with caution in patients with mild heart failure (NYHA class I/II). Treatment with certolizumab pegol must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.

Severe infections, sepsis

No gender/age discrimination

Patients must be monitored closely for signs and symptoms of infections including tuberculosis before, during and after treatment with certolizumab. Because the elimination of certolizumab may take up to 5 months, monitoring should be continued throughout this period .

Treatment with certolizumab must not be initiated in patients with a clinically important active infection, including chronic or localised infections, until the infection is controlled.

Patients who develop a new infection while undergoing treatment with certolizumab should be monitored closely. Administration of certolizumab should be discontinued if a patient develops a new serious infection until the infection is controlled. Physicians should exercise caution when considering the use of certolizumab in patients with a history of recurring or opportunistic infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.

Patients with rheumatoid arthritis may not manifest typical symptoms of infection, including fever, due to their disease and concomitant medicinal products. Therefore, early detection of any infection, particularly atypical clinical presentations of a serious infection, is critical to minimise delays in diagnosis and initiation of treatment.

Serious infections, including sepsis and tuberculosis (including miliary, disseminated and extrapulmonary disease), and opportunistic infections (e.g. histoplasmosis, nocardia, candidiasis) have been reported in patients receiving certolizumab. Some of these events have been fatal.

Tuberculosis

No gender/age discrimination

Before initiation of therapy with certolizumab, all patients must be evaluated for both active or inactive (latent) tuberculosis infection. This evaluation should include a detailed medical history for patients with a personal history of tuberculosis, with possible previous exposure to others with active tuberculosis, and with previous and/or current use of immunosuppressive therapy. Appropriate screening tests, e.g. tuberculin skin test and chest X -ray, should be performed in all patients (local recommendations may apply). It is recommended that the conduct of these tests should be recorded in the patient’s alert card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.

If active tuberculosis is diagnosed prior to or during treatment, certolizumab therapy must not be initiated and must be discontinued.

If inactive (‘latent’) tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted. In all situations described below, the benefit/risk balance of certolizumab therapy should be very carefully considered.

If latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with certolizumab and in accordance with local recommendations.

Use of anti-tuberculosis therapy should also be considered before the initiation of certolizumab in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and in patients who have significant risk factors for tuberculosis despite a negative test for latent tuberculosis. Biological tests for tuberculosis screening should be considered before starting certolizumab treatment if there is any potential latent tuberculosis infection, regardless of BCG vaccination.

Patients should be instructed to seek medical advice if signs/symptoms (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) suggestive of a tuberculosis infection occur during or after therapy with certolizumab.