Adalimumab

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Identification

Adalimumab is a monoclonal anti-tumor necrosis factor alpha antibody used in the treatment of a wide variety of inflammatory conditions such as rheumatoid arthritis, Crohn's disease, and ankylosing spondylitis.

Adalimumab is a subcutaneously administered biological disease modifier for the treatment of rheumatoid arthritis and other chronic debilitating diseases mediated by tumor necrosis factor. 2,3 It was originally launched by Abbvie in the U.S. and approved in 2002 by the FDA. 1 This drug is frequently known as Humira. It is produced by recombinant DNA technology using a mammalian cell expression system. This drug is available in a prefilled syringe form and convenient pen form for subcutaneous self-administered doses. 1

Several biosimilars to adalimumab. Adalimumab-atto was the first adalimumab biosimilar approved by the FDA in 2016. 19 Adalimumab-adaz was approved by the FDA on October 31, 2018. 12 Other biosimilars include adalimumab-fkjp - which was approved in July 2022 -, 17 adalimumab-bwwd - which was approved in August 2022 -, 18 and adalimumab-aacf - which was approved in October 2023. 31 A biosimilar marketed as Hyrimoz, a high-concentration formulation of adalimumab, is also available. 20,21

Type Biotech Groups Approved, Experimental Biologic Classification Protein Based Therapies
Monoclonal antibody (mAb) Protein Structure Protein Chemical Formula C₆₄₂₈H₉₉₁₂N₁₆₉₄O₁₉₈₇S₄₆ Protein Average Weight 144190.3 Da Sequences

> Adalimumab Light chain: DIQMTQSPSSLSASVGDRVTITCRASQGIRNYLAWYQQKPGKAPKLLIYAASTLQSGVPS RFSGSGSGTDFTLTISSLQPEDVATYYCQRYNRAPYTFGQGTKVEIKRTVAAPSVFIFPP SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC

> Adalimumab Heavy chain: EVQLVESGGGLVQPGRSLRLSCAASGFTFDDYAMHWVRQAPGKGLEWVSAITWNSGHIDY ADSVEGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCAKVSYLSTASSLDYWGQGTLVTVS SASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQS SGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLG GPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQY NSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRD ELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSR WQQGNVFSCSVMHEALHNHYTQKSLSLSPGK

• Adalimumab
• Adalimumab (genetical recombination)
• adalimumab-adaz
• adalimumab-adbm
• adalimumab-afzb
• adalimumab-atto
• adalimumab-bwwd
• adalimumab-fkjp

• ABP-501
• BCD-057
• BI-695501
• BI695501
• CHS-1420
• D2E7
• FKB327
• GP-2017
• GP2017
• LU-200134
• LU200134
• M-923
• M923
• MSB-11022
• MSB11022
• ONS-3010
• SB-5
• SB5

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Pharmacology

Adalimumab is indicated for the following conditions: 31

• Moderately to severely active Rheumatoid Arthritis (RA) in adults, as monotherapy or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 16,17,18,19,20,21,31
• Moderately to severely active polyarticular Juvenile Idiopathic Arthritis (JIA) in patients two years of age and older, as monotherapy or in combination with methotrexate. 16,17,18,19,20,21,31
• Psoriatic Arthritis (PsA) in adults. 16,17,18,19,20,21,31
• Ankylosing Spondylitis (AS) in adults. 16,17,18,19,20,21,31
• Moderately to severely active Crohn’s Disease (CD) in adults and pediatric patients six years of age and older. 16,17,18,19,20,21,31
• Moderately to severely active Ulcerative Colitis (UC) in adults. Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. 16,17,18,19,20,21,31
• Moderate to severe chronic plaque psoriasis in adult candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate. 16,17,18,19,20,21,31
• Moderate to severe Hidradenitis Suppurativa (HS) in adults. 19
• Non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients two years of age and older. 15

Adalimumab has also been used off-label to treat Pyoderma gangrenosum. 5,6

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After treatment with adalimumab, a decrease in levels of acute phase reactant proteins of inflammation (C­ reactive protein [CRP] and erythrocyte sedimentation rate [ESR]) and serum cytokines (IL-6) was measured compared to baseline in patients diagnosed with rheumatoid arthritis. A decrease in CRP levels was also observed in patients diagnosed with Crohn’s disease. Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that lead to the tissue remodeling responsible for cartilage destruction were also found to be decreased after administration of adalimumab. 15 A reduction in signs and symptoms of disease, the induction of clinical response, inhibition of structural damage, and improvements in physical function in adult and pediatric patients with various inflammatory conditions have been demonstrated. 1,3,15

Mechanism of action

Adalimumab binds with specificity to tumor necrosis factor-alpha (TNF-alpha) and inhibits its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also lyses surface tumor necrosis factor expressing cells in vitro when in the presence of complement. 2,3 Adalimumab does not bind or inactivate lymphotoxin (Tumor necrosis factor-beta). TNF is a naturally occurring cytokine that plays a role in normal inflammatory and immune responses. 3 Increased levels of TNF are found in the joint synovial fluid of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis patients, and play an imperative role in pathologic inflammation and joint destruction that are major complications of these diseases. Increased levels of TNF are also measured in psoriasis plaques. In plaque psoriasis, treatment with adalimumab may decrease the epidermal thickness and inflammatory cell infiltration. The relationship between these pharmacodynamics and the mechanism(s) by which adalimumab achieves its clinical effects is not known. Additionally, adalimumab alters biological responses that are induced/regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration during inflammation (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 1-2 X 10-10M). 15

The maximum serum concentration (Cmax) and the time to reach the maximum concentration (Tmax) were 4.7 ± 1.6 μg/mL and 131 ± 56 hours respectively, following a single 40 mg subcutaneous administration of adalimumab to healthy adult subjects. The average absolute bioavailability of adalimumab estimated from three clinical studies after a single 40 mg subcutaneous dose of adalimumab was 64%. The pharmacokinetics of adalimumab showed a linear pattern over the dose range of 0.5 to 10.0 mg/kg following a single intravenous dose. 15

Volume of distribution

The distribution volume (Vss) ranged from 4.7 to 6.0 L following intravenous administration of doses ranging from 0.25 to 10 mg/kg in RA patients. 15

Metabolism Not Available Route of elimination

Adalimumab is most likely removed by opsonization via the reticuloendothelial system. 7

The mean terminal half-life was approximately 2 weeks, ranging from 10 to 20 days across studies. 15

The single-dose pharmacokinetics of adalimumab in RA patients were determined in several studies with intravenous doses ranging from 0.25 to 10 mg/kg. The systemic clearance of adalimumab is approximately 12 mL/hr. In long-term studies with dosing more than two years, there was no evidence of changes in clearance over time in RA patients. 15

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Doses up to 10 mg/kg have been administered to patients in clinical trials without evidence of dose-limiting toxicities. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately. 16

Pathways Not Available Pharmacogenomic Effects/ADRs

Interactions

This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.

Products

Our datasets provide approved product information including: dosage, form, labeller, route of administration, and marketing period.

International/Other Brands Amjevita (Amgen, Inc.) / Cyltezo (Boehringer Ingelheim Pharmaceuticals, Inc.) / Humira Pen (Abbott Laboratories) Brand Name Prescription Products

Categories

• L04AB — Tumor necrosis factor alpha (TNF-alpha) inhibitors
• L04A — IMMUNOSUPPRESSANTS
• L04 — IMMUNOSUPPRESSANTS
• L — ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

• Agents reducing cytokine levels
• Amino Acids, Peptides, and Proteins
• Anti-Inflammatory Agents
• Antibodies
• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Antineoplastic and Immunomodulating Agents
• Antirheumatic Agents
• Biological Products
• Biologics for Rheumatoid Arthritis Treatment
• Blood Proteins
• Disease-modifying Antirheumatic Agents
• Globulins
• Immunoglobulins
• Immunoproteins
• Immunosuppressive Agents
• Miscellaneous GI Drugs
• Proteins
• Serum Globulins
• Tumor necrosis factor alpha (TNF-alpha) inhibitors
• Tumor Necrosis Factor Blockers
• Tumor Necrosis Factor Receptor Blocking Activity

• Humans and other mammals

Chemical Identifiers

References

1. Kivitz A, Segurado OG: HUMIRA pen: a novel autoinjection device for subcutaneous injection of the fully human monoclonal antibody adalimumab. Expert Rev Med Devices. 2007 Mar;4(2):109-16. doi: 10.1586/17434440.4.2.109. [Article]
2. Mease PJ: Adalimumab in the treatment of arthritis. Ther Clin Risk Manag. 2007 Mar;3(1):133-48. [Article]
3. Scheinfeld N: Adalimumab (HUMIRA): a review. J Drugs Dermatol. 2003 Aug;2(4):375-7. [Article]
4. Scheinfeld N: Adalimumab: a review of side effects. Expert Opin Drug Saf. 2005 Jul;4(4):637-41. doi: 10.1517/14740338.4.4.637. [Article]
5. Fonder MA, Cummins DL, Ehst BD, Anhalt GJ, Meyerle JH: Adalimumab therapy for recalcitrant pyoderma gangrenosum. J Burns Wounds. 2006 Nov 20;5:e8. [Article]
6. Hinterberger L, Muller CS, Vogt T, Pfohler C: Adalimumab: a treatment option for pyoderma gangrenosum after failure of systemic standard therapies. Dermatol Ther (Heidelb). 2012 Dec;2(1):6. doi: 10.1007/s13555-012-0006-6. Epub 2012 May 12. [Article]
7. Ryman JT, Meibohm B: Pharmacokinetics of Monoclonal Antibodies. CPT Pharmacometrics Syst Pharmacol. 2017 Sep;6(9):576-588. doi: 10.1002/psp4.12224. Epub 2017 Jul 29. [Article]
8. Farrugia M, Baron B: The role of TNF-alpha in rheumatoid arthritis: a focus on regulatory T cells. J Clin Transl Res. 2016 Sep 15;2(3):84-90. eCollection 2016 Nov 10. [Article]
9. Matsuno H, Yudoh K, Katayama R, Nakazawa F, Uzuki M, Sawai T, Yonezawa T, Saeki Y, Panayi GS, Pitzalis C, Kimura T: The role of TNF-alpha in the pathogenesis of inflammation and joint destruction in rheumatoid arthritis (RA): a study using a human RA/SCID mouse chimera. Rheumatology (Oxford). 2002 Mar;41(3):329-37. doi: 10.1093/rheumatology/41.3.329. [Article]
10. Bullock J, Rizvi SAA, Saleh AM, Ahmed SS, Do DP, Ansari RA, Ahmed J: Rheumatoid Arthritis: A Brief Overview of the Treatment. Med Princ Pract. 2018;27(6):501-507. doi: 10.1159/000493390. Epub 2018 Sep 2. [Article]
11. Patent: Methods related to adalimumab [Link]
12. Sandoz received US FDA approval for bio similar, Hyrimoz [Link]
13. HUMIRA website [Link]
14. Abbvie Website [Link]
15. FDA Approved Drug Products: HUMIRA (adalimumab) injection [Link]
16. FDA Approved Drug Products: HUMIRA (adalimumab) injection 2022 [Link]
17. FDA Approved Drug Products: HULIO (adalimumab-fkjp) injection, for subcutaneous use [Link]
18. FDA Approved Drug Products: HADLIMA (adalimumab-bwwd) injection, for subcutaneous use [Link]
19. FDA Approved Drug Products: AMJEVITA (adalimumab-atto) injection, for subcutaneous use (November 2022) [Link]
20. FDA Approved Drug Products: HYRIMOZ (adalimumab-adaz) injection, for subcutaneous use [Link]
21. EMA Approved Drug Products: Hyrimoz (adalimumab) Subcutaneous Injection [Link]
22. FDA Approved Drug Products: YUFLYMA (adalimumab-aaty) injection, for subcutaneous use [Link]
23. FDA Approved Drug Products: HADLIMA (adalimumab-bwwd) injection, for subcutaneous use (June 2023) [Link]
24. FDA Approved Drug Products: CYLTEZO® (adalimumab-adbm) injection, for subcutaneous use (July 2023) [Link]
25. FDA Approved Drug Products: AMJEVITA (adalimumab-atto) injection, for subcutaneous use (July 2023) [Link]
26. FDA Approved Drug Products: HADLIMA (adalimumab-bwwd) injection, for subcutaneous use (July 2023) [Link]
27. FDA Approved Drug Products: HULIO (adalimumab-fkjp) injection, for subcutaneous use (September 2023) [Link]
28. FDA Approved Drug Products: HYRIMOZ (adalimumab-adaz) injection, for subcutaneous use (September 2023) [Link]
29. FDA Approved Drug Products: ABRILADA(adalimumab-afzb) injection, for subcutaneous use (October2023) [Link]
30. FDA Approved Drug Products: HYRIMOZ (adalimumab-aaty) injection, for subcutaneous use (October2023) [Link]
31. FDA Approved Drug Products: IDACIO (adalimumab-aacf) injection, for subcutaneous use (October 2023) [Link]

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