Adalimumab products bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab products also lyse surface TNF expressing cells in vitro in the presence of complement. Adalimumab products do not bind or inactivate lymphotoxin (TNF-beta). TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated concentrations of TNF are found in the synovial fluid of patients with RA, JIA, PsA, and AS and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases. Increased concentrations of TNF are also found in psoriasis plaques. In Ps, treatment with YUSIMRY may reduce the epidermal thickness and infiltration of inflammatory cells. The relationship between these pharmacodynamic activities and the mechanism(s) by which adalimumab products exert their clinical effects is unknown. Adalimumab products also modulate biological responses that are induced or regulated by TNF, including changes in the concentrations of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC of 1-2 X 10 M).

YUSIMRY is a tumor necrosis factor (TNF) blocker indicated for:

• Rheumatoid Arthritis (RA): 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 RA.
• Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
• Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
• Ankylosing Spondylitis (AS): reducing signs andsymptoms in adult patients with active AS. Crohn's Disease (CD) (1.5): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older.
• Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adult patients.
• Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
• Plaque Psoriasis (Ps): 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): treatment of moderate to severe hidradenitis suppurativa in adult patients.
• Uveitis (UV): The treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

Administered by subcutaneous injection

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis:

• Adults: 40 mg every other week.

Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week.

See package insert for complete information.

Most common adverse reactions (>10%) are: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache and rash.

None.

• Serious infections: Do not start YUSIMRY during an active infection. If an infection develops, monitor carefully, and stop YUSIMRY if infection becomes serious.
• Invasive fungal infections: For patients who develop a systemic illness on YUSIMRY, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic. 
• Malignancies: Incidence of malignancies was greater in adalimumab- treated patients than in controls.
• Anaphylaxis or serious hypersensitivity reactions may occur.
• Hepatitis B virus reactivation: Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop YUSIMRY and begin anti-viral therapy.
• Demyelinating disease: Exacerbation or new onset, may occur.
• Cytopenias, pancytopenia: Advise patients to seek immediate medical attention if symptoms develop, and consider stopping YUSIMRY.
• Heart failure: Worsening or new onset, may occur.
• Lupus-like syndrome: Stop YUSIMRY if syndrome develops.