Ciptunec/Ardalicip

Ciptunec/Ardalicip (adalimumab) was approved for the following therapeutic use:

Rheumatoid arthritis

Ciptunec and Ardalicip are indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. This includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate.

Ciptunec and Ardalicip can be used alone or in combination with methotrexate.

Juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis

Ciptunec and Ardalicip in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older weighing ≥ 30 kg who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs). Ciptunec and Ardalicip can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Enthesitis-related arthritis

Ciptunec and Ardalicip are indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.

Psoriatic arthritis

Ciptunec and Ardalicip are indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous DMARDs has been inadequate.

Ankylosing spondylitis

Ciptunec and Ardalicip are indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

Crohn’s disease in adults and children (≥ 6 years; weighing ≥ 40 kg)

Ciptunec and Ardalicip are indicated for the treatment of moderate to severe Crohn’s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients;

• who have had an inadequate response to conventional therapies or,
• who have lost response to or are intolerant to infliximab.

Ulcerative colitis

Ciptunec and Ardalicip are indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. Patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time (see section 5.1 Pharmacodynamic properties -clinical trials).

Psoriasis in adults and children

Ciptunec and Ardalicip are indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Ciptunec and Ardalicip are indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age weighing ≥ 40 kg who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.

Hidradenitis suppurativa in adults and adolescents (from 12 years of age)

Ciptunec and Ardalicip are indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.

Uveitis

Ciptunec and Ardalicip are indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.