Drug updated on 9/4/2024
Dosage Form | Injection (subcutaneous; 80 mg/0.8 mL, 40 mg/0.8 mL, 40 mg/0.4 mL [single-dose prefilled pen]); Injection (subcutaneous; 80 mg/0.8 mL, 40 mg/0.8 mL, 40 mg/0.4 mL, 20 mg/0.4 mL, 20 mg/0.2 mL, 10 mg/0.2 mL, 10 mg/0.1 mL [single-dose prefilled glass syringe]); Injection (subcutaneous; 40 mg/0.8 mL [single-dose glass vial for institutional use only]) |
Drug Class | Tumor necrosis factor (TNF) blockers |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
- Indicated for juvenile idiopathic arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
- Indicated for psoriatic arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
- Indicated for ankylosing spondylitis (AS): reducing signs and symptoms in adult patients with active AS.
- Indicated for Crohn’s disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
- Indicated for ulcerative colitis (UC): treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
- Indicated for 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.
- Indicated for hidradenitis suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
- Indicated for uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
Latest News
Summary
- Humira (adalimumab) 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 (RA); reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients 2 years of age and older; reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PsA); reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS); treatment of moderately to severely active Crohn’s disease (CD) in adults and pediatric patients 6 years of age and older; treatment of moderately to severely active ulcerative colitis (UC) in adults and pediatric patients 5 years of age and older, with limitations of use for patients who have lost response to or were intolerant to TNF blockers; treatment of adult patients with moderate to severe chronic plaque psoriasis (Ps) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate; treatment of moderate to severe hidradenitis suppurativa (HS) in patients 12 years of age and older; and treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
- This summary is based on the review of 12 systematic review(s)/meta-analysis(es). [1-12]
- Non-Infectious Uveitis (NIU): Adalimumab achieved complete remission of inflammation in 39.6% of patients, with partial or complete remission observed in 86.4% of patients. Comparable outcomes were observed with infliximab (37.5% complete remission, 88.6% partial or complete remission). No significant corticosteroid-sparing effect differences were noted between the two treatments.
- Childhood Crohn’s Disease (CD): Remission was induced in 59% of pediatric patients treated with adalimumab, with 60% showing a response to therapy. Maintenance of remission and response was achieved in 57% and 63% of patients, respectively.
- Plaque Psoriasis: Adalimumab biosimilars demonstrated similar effectiveness to reference agents in achieving PASI 75, PASI 50, PASI 90, and PASI 100 responses.
- Ulcerative Colitis (UC): An annual loss of response rate of 13% was observed with adalimumab, while dose escalation was required annually in 21.3% of cases, regaining clinical benefit in 52.3% of those escalated.
- Non-Infectious Uveitis (NIU): The incidence of adverse events was 12.12% for adalimumab compared to 17.91% for infliximab, indicating a significant difference.
- Psoriasis: Adalimumab was associated with a higher incidence of adverse events, infections, and injection site reactions compared to the control group, though no significant differences were observed in serious adverse events, serious infections, or drug discontinuation due to adverse events.
- Hidradenitis Suppurativa (HS): Weekly administration of adalimumab did not result in significant differences in adverse events when compared to placebo.
- The Population Types and Subgroup Considerations section highlights specific subgroups for Childhood Crohn’s Disease (pediatric patients) and Hidradenitis Suppurativa (weekly vs. every other week administration), with limited subgroup analysis in other conditions.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Humira (adalimumab) Prescribing Information. | 2024 | AbbVie Inc., North Chicago, IL |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. | 2021 | Arthritis & Rheumatology |
British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. | 2019 | BMJ Journals |
ACG clinical guideline: ulcerative colitis in adults. | 2019 | The American Journal of Gastroenterology |
Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. | 2019 | Journal of the American Academy of Dermatology |