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adalimumab (Humira, Idacio, Yusimry, Yuflyma)

Biosimilar adalimumab-atto (Amjevita). FDA-approved Sept. 2016 [12] Indications: 1) rheumatoid arthritis - may be used in combination with methotrexate [4] 2) psoriasis, psoriatic arthritis [6] 3) ulcerative colitis [7], Crohn's disease [10] 4) ankylosing spondylitis [9] 5) severe hidradenitis suppurativa (not FDA-approved use) [8] Contraindications: - concurrent use of other biologic agent (abatacept, rituximab, anakinra, other TNF inhibitor) - active tuberculosis [10] - disseminated candidiasis - mycosis, fungus infection [10] - malignancy [10] - severe infection [10] Pregnancy category: B [9] Dosage: 20-80 mg SC every other week [2] Monitor: - screening for tuberculosis [9] - CBC LFTs, serum creatinine at baseline & every 3-6 months thereafter [9] - annual & as indicated (especially fever) - complete blood count (CBC) - serum C-reactive protein testing - serum ALT & GGT - serum glucose Adverse effects: 1) increased risk of infection [5,11] 2) may increase risk of cancer [5] 3) adalimumab during pregnancy may persist in the offspring's blood for nearly 2 years; a delay in infant immunization may be indicated [13] 4) drug-induced subacute cutaneous lupus erythematosus [9] Laboratory: - adalimumab in serum/plasma Mechanism of action: - humanized monoclonal antibody to tumor necrosis factor-alpha (TNF-alpha inhibitor) Notes: Cost is about $1500 per month Abbott may provide Humira free to low-income or Medicare patients who don't have prescription drug benefits.

Interactions

drug adverse effects of immunosuppressive agents monitor with immunosuppressive agents

Specific

adalimumab-adbm (Cyltezo) adalimumab-atto (Amjevita)

General

recombinant protein; chimer pharmaceutical monoclonal antibody tumor necrosis factor (TNF) inhibitor

References

  1. Prescriber's Letter 10(2):8 2003 866-4-HUMIRA
  2. Journal Watch 23(5):40, 2003 Weinblatt ME et al, Arthritis Rheum 48:35, 2003
  3. Department of Veterans Affairs, VA National Formulary, VISN 21 preferred monoclonal Ab to TNF-alpha
  4. Breedveld FC et al, The PREMIER study: A multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum 2006, 54:26 PMID: 16385520
  5. Prescriber's Letter 13(7): 2006 Safety Concerns of Anti-TNF Antibody Therapy Detail-Document#: 220711 (subscription needed) http://www.prescribersletter.com
  6. van Lumig PPM et al Relevance of laboratory investigations in monitoring patients with psoriasis on etanercept or adalimumab. Br J Dermatol 2011 Mar 24 PMID: 21428975 http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2133.2011.10329.x/abstract;jsessionid=A6466AB81A3BD26BF82E78A14E9B7D68.d01t03
  7. Physician's First Watch, Aug 29 2012 Massachusetts Medical Society http://www.jwatch.org - Reuters UPDATE 2-US FDA advisers back wider use of Abbott's Humira Aug 28, 2012 http://www.reuters.com/article/2012/08/28/fda-abbott-idUSL2E8JSE3W20120828 - FDA News Release: Sept. 28, 2012 FDA approves Humira to treat ulcerative colitis http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm321650.htm
  8. Kimball AB et al. Adalimumab for the treatment of moderate to severe hidradenitis suppurativa: A parallel randomized trial. Ann Intern Med 2012 Dec 18; 157:846 PMID: 23247938
  9. Medical Knowledge Self Assessment Program (MKSAP) 16, 17, 18. American College of Physicians, Philadelphia 2012, 2015, 2018
  10. Deprecated Reference
  11. Kalb RE, Fiorentino DF, Lebwohl MG et al Risk of Serious Infection With Biologic and Systemic Treatment of Psoriasis: Results From the Psoriasis Longitudinal Assessment and Registry (PSOLAR). JAMA Dermatol. 2015 May 13 PMID: 25970800
  12. FDA News Release. September 23, 2016 FDA approves Amjevita, a biosimilar to Humira. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522243.htm
  13. Labetoulle R, Roblin X, Paul S Prolonged Persistence of Adalimumab Transferred From Mother to Infant During Pregnancy. Ann Intern Med. 2018. March 6. PMID: 29507939 http://annals.org/aim/article-abstract/2674120/prolonged-persistence-adalimumab-transferred-from-mother-infant-during-pregnancy
  14. Humira Prescribing Information http://www.rxabbott.com/pdf/humira.pdf