Therapeutic Indications

Abatacept is indicated for:

Polyarticular juvenile idiopathic arthritis

Irrespective of gender only Children (1 year - 12 years old) , Adolescents (12 years - 18 years old)

Abatacept in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (JIA) in paediatric patients 6 years of age and older who have had an insufficient response to other DMARDs including at least one TNF inhibitor.

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

Treatment 1: Intravenous - 30-minute intravenous infusion

Psoriatic Arthritis

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

Abatacept, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients when the response to previous DMARD therapy including MTX has been inadequate, and for whom additional systemic therapy for psoriatic skin lesions is not required.

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

Treatment 1: Intravenous

Active rheumatoid arthritis

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

Abatacept in combination with methotrexate is indicated for:

  • the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor.
  • the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate

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

Treatment 1: Intravenous - 30-minute intravenous infusion

Contraindications

Active ingredient Abatacept is contraindicated in the following cases:

Live vaccines should not be given concurrently with abatacept

No gender/age discrimination

Live vaccines should not be given concurrently with abatacept or within 3 months of its discontinuation. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving abatacept. Medicinal products that affect the immune system, including abatacept, may blunt the effectiveness of some immunisations.

Exploratory studies to assess the effect of abatacept on the antibody response to vaccination in healthy subjects as well as the antibody response to influenza and pneumococcal vaccines in rheumatoid arthritis patients suggested that abatacept may blunt the effectiveness of the immune response, but did not significantly inhibit the ability to develop a clinically significant or positive immune response.

Abatacept was evaluated in an open-label study in rheumatoid arthritis patients administered the 23-valent pneumococcal vaccine. After pneumococcal vaccination, 62 of 112 abatacept-treated patients were able to mount an adequate immune response of at least a 2-fold increase in antibody titers to pneumococcal polysaccharide vaccine.

Abatacept was also evaluated in an open-label study in rheumatoid arthritis patients administered the seasonal influenza trivalent virus vaccine. After influenza vaccination, 73 of 119 abatacept-treated patients without protective antibody levels at baseline were able to mount an adequate immune response of at least a 4-fold increase in antibody titers to trivalent influenza vaccine. 2

TNF blocking agents

No gender/age discrimination

Abatacept is contraindicated with TNF blocking agents.

There is limited experience with the use of abatacept in combination with TNF-inhibitors. While TNF-inhibitors did not influence abatacept clearance, in placebo-controlled clinical trials, patients receiving concomitant treatment with abatacept and TNF-inhibitors experienced more infections and serious infections than patients treated with only TNF-inhibitors. Therefore, concurrent therapy with abatacept and a TNF-inhibitor is not recommended. 2

Severe and uncontrolled infections

No gender/age discrimination

Abatacept is contraindicated in severe and uncontrolled infections (such as sepsis and opportunistic infections)

Serious infections, including sepsis and pneumonia, have been reported with abatacept. Some of these infections have been fatal. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which in addition to their underlying disease, could further predispose them to infections. Treatment with abatacept should not be initiated in patients with active infections until infections are controlled. Physicians should exercise caution when considering the use of abatacept in patients with a history of recurrent infections or underlying conditions which may predispose them to infections. Patients who develop a new infection while undergoing treatment with abatacept should be monitored closely. Administration of abatacept should be discontinued if a patient develops a serious infection.

No increase of tuberculosis was observed in the pivotal placebo-controlled studies; however, all abatacept patients were screened for tuberculosis. The safety of abatacept in individuals with latent tuberculosis is unknown. There have been reports of tuberculosis in patients receiving abatacept. Patients should be screened for latent tuberculosis prior to initiating abatacept. The available medical guidelines should also be taken into account.

Anti-rheumatic therapies have been associated with hepatitis B reactivation. Therefore, screening for viral hepatitis should be performed in accordance with published guidelines before starting therapy with abatacept.

Treatment with immunosuppressive therapy, such as abatacept, may be associated with progressive multifocal leukoencephalopathy (PML). If neurological symptoms suggestive of PML occur during abatacept therapy, treatment with abatacept should be discontinued and appropriate diagnostic measures initiated. 2

Lactation

No gender/age discrimination

Abatacept has been shown to be present in rat milk. It is not known whether abatacept is excreted in human milk. Women should not breastfeed while treated with abatacept and for up to 14 weeks after the last dose of abatacept treatment.

Pregnancy

No gender/age discrimination

There are no adequate data from use of abatacept in pregnant women. In pre-clinical embryo-fetal development studies no undesirable effects were observed at doses up to 29-fold a human 10 mg/kg dose based on AUC. In a pre- and postnatal development study in rats limited changes in immune function were observed at 11-fold a human 10 mg/kg dose based on AUC. Abatacept should not be used in pregnant women unless clearly necessary. Women of child-bearing potential should use effective contraception during treatment with abatacept and up to 14 weeks after the last dose of abatacept treatment.