Adalimumab

In this article, we will discuss about Adalimumab (Dosage). So, let’s get started.

Adalimumab

Mechanism of Action

Adalimumab binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF
receptors. Adalimumab also lyses surface TNF expressing cells in vitro in the presence of complement. Adalimumab does not bind or inactivate lymphotoxin (TNF-beta). TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF are found in the synovial fluid of rheumatoid arthritis, including juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis patients and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases. Increased levels of TNF are also found in psoriasis (Ps) plaques. In plaque psoriasis, treatment with HUMIRA may reduce the epidermal thickness and infiltration of inflammatory cells. The relationship between these pharmacodynamic activities and the mechanism(s) by which Adalimumab (HUMIRA®) exerts its clinical effects is unknown.

Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 1-2 X 10-¹⁰M).

Indications

Rheumatoid Arthritis

Adalimumab (HUMIRA®) is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. HUMIRA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

Juvenile Idiopathic Arthritis

Adalimumab (HUMIRA®) is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in pediatric patients 4 years of age and older. HUMIRA can be used alone or in combination with methotrexate.

Psoriatic Arthritis

Adalimumab (HUMIRA®) is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HUMIRA can be used alone or in
combination with non-biologic DMARDS.

Ankylosing Spondylitis

Adalimumab (HUMIRA®) is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

Crohn’s Disease

Adalimumab (HUMIRA®) is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Adalimumab (HUMIRA®) is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.

Plaque Psoriasis

Adalimumab (HUMIRA®) 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. Adalimumab (HUMIRA®) should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

Dosage

HUMIRA is administered by subcutaneous injection.

Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

The recommended dose of Adalimumab (HUMIRA®) for adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PSA), or ankylosing spondylitis (AS) is 40 mg administered every other week. Methotrexate (MTX), other
non-biologic DMARDS, glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment with Adalimumab (HUMIRA®). In the treatment of RA, some patients not taking concomitant MTX may derive additional benefit from increasing the dosing frequency of HUMIRA to 40 mg every week.

Juvenile Idiopathic Arthritis

The recommended dose of Adalimumab (HUMIRA®) for pediatric patients 4 to 17 years of age with polyarticular juvenile
idiopathic arthritis (JIA) is based on weight as shown below. MTX, glucocorticoids, NSAIDs, and/or
analgesics may be continued during treatment with Adalimumab (HUMIRA®).

Pediatric Patients (4 to 17 years) – Dose

15 kg (33 lbs) to <30 kg (66 lbs) – 20 mg every other week (20 mg Prefilled Syringe)

≥30 kg (66 lbs) – 40 mg every other week (Adalimumab (HUMIRA®) Pen or 40 mg Prefilled Syringe)

Limited data are available for Adalimumab (HUMIRA®) treatment in pediatric patients with a weight below 15 kg.

Crohn’s Disease

The recommended Adalimumab (HUMIRA®) dose regimen for adult patients with Crohn’s disease is 160 mg initially on Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) begin a maintenance dose of 40 mg every other week. Aminosalicylates and/or corticosteroids may be continued during treatment with Adalimumab (HUMIRA®). Azathioprine, 6-mercaptopurine (6-MP) or MTX may be continued during treatment with Adalimumab (HUMIRA®) if necessary. The use of Adalimumab (HUMIRA®) in Crohn’s disease beyond one year has not been evaluated in controlled clinical studies.

Plaque Psoriasis

The recommended dose of Adalimumab (HUMIRA®) for adult patients with plaque psoriasis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. The use of Adalimumab (HUMIRA®) in
moderate to severe chronic plaque psoriasis beyond one year has not been evaluated in controlled clinical studies.

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