Drug updated on 4/17/2024
| 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.
Summary
- Adalimumab (Humira) is used for treating a variety of conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease in adults and children over 6 years old, ulcerative colitis in adults and children over 5 years old. It is also applied in cases of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy when other therapies are less appropriate. Additionally, it is employed for moderate to severe hidradenitis suppurativa in patients aged 12 and older, as well as non-infectious intermediate uveitis.
- The findings are based on the examination of twelve systematic reviews/meta-analyses on adalimumab.
- Compared to infliximab for treating Non-Infectious Uveitis (NIU), adalimumab was found to have similar efficacy but exhibited slightly fewer adverse events, indicating a better safety profile.
- For pediatric populations with Crohn's Disease (CD), adalimumab has been effective in inducing remission while maintaining acceptable safety levels with mostly non-severe adverse events reported.
- Biosimilar versions of Humira have shown similar effectiveness and safety profiles in treating moderate-to-severe plaque psoriasis, suggesting they could serve as viable alternative options.
- During a comparison of loss response rates between Humira and infliximab among Ulcerative Colitis patients within the first year, higher rates were observed with Humira, although its clinical benefits remained significant after dose escalation.
- Weekly administration of Humira significantly enhanced clinical responses without increasing adverse effects among Hidradenitis Suppurativa patients, thus making it a possible first-line treatment option.
- Humira was more effective than placebo by inducing quicker response times within four weeks along with better patient remissions among CD sufferers, despite limited data on serious side effects.
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 |