|
Indications:
ADULTS
Rheumatoid arthritis (RA)
ABRILADA is indicated for reducing signs and symptoms and inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease‑modifying anti‑rheumatic drugs (DMARDs). ABRILADA can be used alone or in combination with methotrexate (MTX) or other DMARDs.
ABRILADA, in combination with MTX, can also be used in the treatment of patients with recently diagnosed moderate to severely active rheumatoid arthritis who have not received methotrexate
Psoriatic arthritis (PsA)
ABRILADA is indicated for reducing signs and symptoms of active arthritis in adult patients with moderate to severe psoriatic arthritis when the response to previous DMARD therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X‑ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function
ABRILADA can be used alone or in combination with DMARDs.
Ankylosing spondylitis (AS)
ABRILADA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Crohn’s disease (CD)
ABRILADA is indicated for the treatment of moderate to severe active Crohn’s disease in adults 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 of infliximab. For induction treatment, ABRILADA should be given in combination with corticosteroids. ABRILADA can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inadequate.
Ulcerative colitis (UC)
ABRILADA is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and/or 6‑mercaptopurine (6‑MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Plaque psoriasis
ABRILADA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate.
Hidradenitis suppurativa (HS
ABRILADA is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic HS therapy.
Uveitis
ABRILADA is indicated for the treatment of non‑infectious intermediate, posterior and panuveitis 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.
PAEDIATRICS
Juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis
ABRILADA in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA), in patients 2years of age and older, who have had an inadequate response to one or more DMARDs. ABRILADA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2years.
Enthesitis‑related arthritis
ABRILADA is indicated for the treatment of active enthesitis‑related arthritis in patients, 6years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy.
Paediatric Crohn’s disease
ABRILADA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in paediatric patients, 6years of age and older, with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy
Paediatric plaque psoriasis
ABRILADA is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy
Adolescent hidradenitis suppurativa
ABRILADA is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adolescents from 12years of age with an inadequate response to conventional systemic HS therapy.
Paediatric uveitis
ABRILADA is indicated for the treatment of chronic non‑infectious anterior uveitis in paediatric patients 2 years of age and older who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
|