Adalimumab

(Humira®)

Humira®

Drug updated on 9/4/2024

Dosage FormInjection (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 ClassTumor 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.

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Summary
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  • 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 TitleYearSource
Humira (adalimumab) Prescribing Information.2024AbbVie Inc., North Chicago, IL

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparison of infliximab with adalimumab for the treatment of non-infectious uveitis: a systematic review and meta-analysis.2023BMC Ophthalmology
Efficacy and safety of adalimumab in pediatric patients with Crohn's disease: a systematic review and meta-analysis.2023European Journal of Clinical Pharmacology
Efficacy and safety evaluations of adalimumab biosimilars in the treatment of psoriasis.2023Journal of Dermatological Treatment
Systematic review and meta-analysis: loss of response and need for dose escalation of infliximab and adalimumab in ulcerative colitis.2023Inflammatory Bowel Diseases
Systematic review of studies comparing infliximab and adalimumab in autoimmune uveitis.2023BMJ Open Ophthalmology
Comparison of adalimumab to other targeted therapies in rheumatoid arthritis: results from systematic literature review and meta-analysis.2022Journal of Personalized Medicine
Adalimumab for induction of remission in patients with Crohn's disease: a systematic review and meta-analysis.2022European Journal of Medical Research
Adalimumab effect on pain in hidradenitis suppurativa patients: systematic review and meta-analysis.2022Dermatology Practical & Conceptual
Efficacy and safety of adalimumab in hidradenitis suppurativa: a systematic review and meta-analysis of randomized controlled trials.2021Medicine Open
Efficacy and safety of adalimumab in noninfectious uveitis: a systematic review and meta-analysis of randomized controlled trials.2021Frontiers in Pharmacology
Efficacy and safety of subcutaneous infliximab versus adalimumab, etanercept and intravenous infliximab in patients with rheumatoid arthritis: a systematic literature review and meta-analysis.2021Expert Review of Clinical Immunology
An update on clinical safety of adalimumab in treating psoriasis: a systematic review and meta-analysis based on 20 randomized controlled trials.2019Journal of Cosmetic Dermatology

Clinical Practice Guidelines