What is Adalimumab?
Adalimumab is an active ingredient used for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, suppurative hydrodenitis, Crohn’s disease, ulcerative colitis, uveitis, axial spondylitis.
The brand names of Adalimumab in the United States are: Humira, Hyrimoz, Amjevita and Cyltezo.
Adalimumab Mechanism of Action (MOA)
It binds specifically to TNF and neutralizes its biological function by blocking its interaction with the p55 and p75 receptors of TNF on the cell surface.
Adalimumab also modulates the biological response induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration.
Therapeutic Indications, Uses, and Benefits of Adalimumab
– Active rheumatoid arthritis in adults, with insufficient response to disease-modifying anti-rheumatic drugs including methotrexate or not previously treated in combination with methotrexate and as monotherapy in case of intolerance or when continued treatment with methotrexate is not possible.
– Juvenile idiopathic arthritis: active polyarticular juvenile idiopathic arthritis from the age of 2 years with insufficient response to disease-modifying anti-rheumatic drugs in combination with methotrexate and as monotherapy in case of intolerance or when continued treatment with methotrexate is not possible. Arthritis associated with active enthesitis from the age of 6 with insufficient response, or intolerant to conventional treatment.
– Severe active ankylosing spondylitis with inadequate response to conventional therapy.
– Treatment of adults with severe axial spondyloarthritis without radiographic evidence of AD, but with objective signs of inflammation such as elevated CRP and/or magnetic resonance, who have had an inadequate response or intolerance to NSAIDs.
– Active and progressive psoriatic arthritis in adults. with insufficient response to previous therapy with disease-modifying anti-rheumatic drugs.
– Psoriasis: moderate to severe chronic plaque psoriasis in adults who are candidates for systemic therapy.
– Severe chronic plaque psoriasis in children and adolescents from the age of 4 who have had an inadequate response or are not suitable candidates for topical therapy or phototherapies.
– Moderate to severe active suppurative hydradenitis (inverse acne) in adults and adolescents >12 years with inadequate response to conventional systemic therapy of hidradenitis suppurativa.
– Severe to moderate active Crohn’s disease in adults who have not responded to adequate and complete therapy with corticosteroids and/or immunosuppressants, or who are intolerant or have contraindicated these therapies.
– Moderate to severe active Crohn’s disease in children (6 years and older) who have had an insufficient response to conventional therapy including primary nutritional therapy, 1 corticosteroid and/or 1 immunomodulator, or who are intolerant or have any contraindication to these treatments.
– Severe to moderate active ulcerative colitis in adults who have had an inadequate response to conventional therapy, including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant of or have contraindications to such therapies.
– Uveitis: treatment of intermediate and posterior non-infectious uveitis and panuveitis in ads. who have had an inadequate response to corticosteroids, who need to decrease their corticosteroid treatment, or in those in whom corticosteroid treatment is inappropriate.
– Pediatric uveitis: treatment of chronic non-infectious anterior pediatric uveitis in patients as young as 2 years of age who have had an inadequate response or are intolerant to conventional therapy, or in whom conventional therapy is not adequate.
– Rheumatoid arthritis (with methotrexate): 40 mg in alternate weeks as a single dose. In monotherapy, if they experience a decrease in their response they may increase to 40 mg each week.
– Psoriatic arthritis, ankylosing spondylitis, axial spondylitis without radiographic evidence of AD: 40 mg in alternate weeks as a single dose.
– Active moderate to severe Crohn’s disease: 80 mg in the week 0 followed by 40 mg in the week 2.
If a faster response is necessary, it can be changed to 160 mg in the 0-week (4 injections in one day or 2 injections per day for 2 consecutive days), followed by 80 mg in the 2-week, being aware of the > risk of adverse reactions during the start of treatment. Maintenance: 40 mg in alternate weeks.
– Psoriasis: 80 mg, followed by 40 mg in alternate weeks starting one week after the initial dose. If, after 16 weeks, the response is inadequate, the frequency of dosage can be increased to 40 mg per week.
If an adequate response is achieved by increasing the frequency of dosing, the dose can then be reduced to 40 mg in alternate weeks.
– Hidradenitis suppurativa: initial dose: 160 mg on day 1 (4 injections of 40 mg on one day or 2 daily injections of 40 mg on two consecutive days), followed by 80 mg two weeks later on day 15 (2 injections of 40 mg on one day). Two weeks later (day 29) continue with a dose of 40 mg weekly.
Antibiotic treatment can be continued if necessary. A topical antiseptic liquid is recommended daily for hidradenitis suppurativa lesions. If after 12 weeks of treatment there is no improvement, consider continuity of treatment.
– Moderate to severe ulcerative colitis: induction 160 mg in week 0 (4 injections in one day or 2 injections/day for 2 consecutive days) and 80 mg in week 2; after the recommended dose: 40 mg/cweek every 2 weeks; if there is a decrease in response, the dose frequency can be increased to 40 mg/week.
– Uveitis: initial: 80 mg, followed by 40 mg administered in alternate weeks starting one week after the initial dose. Limited experience in monotherapy at the start of treatment.
May be initiated in combination with corticosteroids and/or another non-biological immunomodulatory agent.
Concomitant treatment with corticosteroids may be adjusted starting 2 weeks after initiation of treatment with adalimumab.
– Pediatric population
– Juvenile polyarticular idiopathic arthritis: 2-12 years: 24 mg/m 2 body surface area up to single dose of 20 mg for patients 2-<4 years and up to single dose max 40 mg in patients aged 4-12 years; in alternate weeks.
From 13 years: 40 mg in alternate weeks regardless of body surface area. Response within the first 12 weeks of treatment.
– Arthritis associated with enthesitis (from the age of 6): 24 mg/ m2 of body surface area up to a single maximum dose of 40 mg; every other week as a single dose.
15 kg-<30 kg: 20 mg every other week.
≥ 30 kg: 40 mg every other week.
– Crohn’s disease: patients < 40 kg: 40 mg in the week 0 followed by 20 mg in the week 2. If a faster response is needed, it can be changed to 80 mg in the week 0 (2 injections in a day), followed by 40 mg in the week 2, being aware of the > risk of suffering adverse reactions during the start of treatment.
Maintenance: 20 mg in alternate weeks. Patients ≥ 40 kg: 80 mg in the week 0 followed by 40 mg in the week 2. If a faster response is needed, it can be changed to 160 mg in the week 0 (4 injections In one day or 2 injections per day for 2 consecutive days), followed by 80 mg in the week 2, being aware of the increased risk of adverse reactions during the start of treatment induction dose. Maintenance: 40 mg in alternate weeks.
– Severe chronic plaque psoriasis in children and adolescents from the age of 4: 0.8 mg/kg (up to a maximum of 40 mg), weekly for the first 2 doses and alternately for the following weeks.
Consider continuation of therapy after 16 weeks if there is no response.
15 kg-<30 kg: Initial dose of 20 mg, followed by 20 mg given in alternate weeks starting one week after the initial dose.
≥ 30 kg: Initial dose of 40 mg, followed by 40 mg given in alternate weeks starting one week after the initial dose.
– Hidradenitis suppurativa in adolescents (from 12 years of age, with a weight of at least 30 kg): recommended dose: 80 mg in the week 0 followed by 40 mg in alternate weeks starting in the week 1. In adolescents with inadequate response to 40 mg in alternate weeks, consider increasing the frequency of dosage to 40 mg weekly.
There is no relevant use in children < 12 years in this indication.
– Pediatric uveitis: there is no experience with adalimumab treatment without concomitant methotrexate treatment. Patients < 30 kg: 20 mg in alternate weeks in combination with methotrexate. When therapy is initiated, a loading dose of 40 mg can be administered one week before maintenance therapy begins.
No clinical data are available on the use of a loading dose in children < 6 years. Patients ≥ 30 kg: 40 mg in alternate weeks in combination with methotrexate. When therapy is initiated a loading dose of 80 mg can be administered one week prior to maintenance therapy. There is no relevant use in children < 2 years in this indication.
It is recommended to evaluate annually the risk/benefit in long-term continuous treatments.
– Safety and efficacy in children aged 4-17 years for ulcerative colitis has not been established. For < 4 years there is no relevant use.
– There is no relevant use for indications of ankylosing spondylitis and psoriatic arthritis in the paediatric population.
Contraindications of Adalimumab
Hypersensitivity to adalimumab; active tuberculosis or other serious infections such as sepsis, and opportunistic infections; moderate to severe heart failure.
Warnings and Cautions with Adalimumab
Renal insufficiency, hepatic insufficiency; neurological effects; caution with pre-existing or emerging peripheral or CNS demyelinating disorders; allergic reactions, discontinue treatment if they occur; malignant neoplastic diseases and lymphoproliferative disorders; hematologic reactions; CHF, caution in mild heart failure (NYHA classes I/II).
Autoimmune processes, may result in the formation of Ac; concomitant with biological FAMES or TNF antagonists such as anakinra, abatacept, not recommended; surgery (infection control). Reactivation of hepatitis B in chronic carriers, monitoring signs and symptoms of active HBV infection during treatment and up to several months later; infection, monitoring for detection of infections (including tuberculosis), before, during, and up to 4 months after treatment.
Do not start treatment with adalimumab if there are active infections (chronic or localized) until they are controlled. If latent tuberculosis is diagnosed, consider benefit/risk and initiate antituberculous prophylaxis as well as in patients with multiple risk factors or a history of active or latent tuberculosis.
Serious infections, including sepsis, of bacterial origin, mycobacterial, invasive fungal, parasitic, viral or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported, in these cases suspend treatment and initiate appropriate antimicrobial or antifungal treatment until the infection is controlled.
In pediatric patients, it is recommended that the vaccination schedule be updated in accordance with current vaccination guidelines before treatment is initiated. Do not vaccinate with live vaccines.
Caution. It has not been studied in this type of patients, there are no dosage recommendations.
Caution. It has not been studied in this type of patients, there are no dosage recommendations.
Interactions with Adalimumab
- Enhanced toxicity with: abatacept, anakinra.
- Antagonizes the effect of: live vaccines.
Pregnancy and Adalimumab
There is no experience in the use of adalimumab in pregnant women. Not recommended, may affect normal immune response in newborn.
It is not known whether adalimumab is excreted in breast milk or absorbed systemically after ingestion. However, because human immunoglobulins are excreted in milk, women should not breast-feed for at least five months after the last treatment with adalimumab.
Effects on driving ability
The influence of adalimumab on the ability to drive and use machines is small. Dizziness (including vertigo, impaired vision, and fatigue) may occur after adalimumab.
Adverse reactions and side effects of Adalimumab
Respiratory tract infections (including upper and lower respiratory tract infections, pneumonia, sinusitis, pharyngitis, nasopharyngitis, and herpesvirus pneumonia); leukopenia (including neutropenia and agranulocytosis); anemia; increased lipids; headache; abdominal pain, nausea, and vomiting; increased liver enzymes; rash (including exfoliative rash); musculoskeletal pain; reaction at the injection site (including erythema at the injection site).
⭐⭐⭐⭐⭐ VIDEO OF ADALIMUMAB/HUMIRA (DRUG)
Source: The content of this active ingredient has been written taking into account the clinical and molecular information of all medicines authorised and marketed in the United States under the Unique Ingredient Identifier (UNII) by the Substance Registration System (SRS) of the Food and Drug Administration (FDA) and the United States Pharmacopeia (USP).
In order to know in detail the information authorized by the FDA for each drug, you should consult the corresponding medication guide authorized by the FDA.
NCI Thesaurus: C65216