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Abrilada (Adalimumab-Afzb)
Adalimumab-afzb binds TNF-alpha and blocks interaction with p55 and p75 cell surface receptors.
Adalimumab-afzb (Abrilada) is a TNF-alpha blocker indicated for multiple inflammatory conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. The drug demonstrates linear pharmacokinetics with a 2-week half-life and 64% bioavailability following subcutaneous administration. Serious infections are the primary safety concern, particularly when combined with other biologic agents like abatacept or anakinra, and live vaccines should be avoided. Abrilada offers clinical benefit across multiple indications but is not recommended for patients who have lost response to or were intolerant to other TNF blockers.
At a glance
| Generic name | Adalimumab-Afzb |
|---|---|
| Sponsor | AbbVie |
| Drug class | TNF blocker |
| Target | Tumor necrosis factor-alpha (TNF-alpha) |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2002 |
| Annual revenue | 10191 |
Mechanism of action
Adalimumab-afzb binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. The drug also lyses surface TNF-expressing cells in vitro in the presence of complement, but does not bind or inactivate lymphotoxin (TNF-beta). TNF is a naturally occurring cytokine involved in normal inflammatory and immune responses, with elevated concentrations found in synovial fluid of patients with RA, JIA, PsA, and AS, playing an important role in pathologic inflammation and joint destruction. Adalimumab-afzb modulates biological responses induced or regulated by TNF, including changes in concentrations of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 1–2 × 10⁻¹⁰ M). The relationship between these pharmacodynamic activities and the mechanism(s) by which adalimumab products exert their clinical effects is unknown.
Approved indications
- Ankylosing spondylitis
- Axial spondyloarthritis
- Behcet's disease
- Crohn's disease
- Hidradenitis suppurativa
- Juvenile idiopathic arthritis
- Non-infectious anterior uveitis
- Non-infectious intermediate, posterior and panuveitis
- Plaque psoriasis
- Psoriasis with arthropathy
- Psoriatic arthritis
- Pustular psoriasis
- Pyoderma gangrenosum
- Rheumatoid arthritis
- Ulcerative colitis
Boxed warnings
- WARNING: SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including ABRILADA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue ABRILADA if a patient develops a serious infection or sepsis. Reported infections include: • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before ABRILADA use and during therapy. Initiate treatment for latent TB prior to ABRILADA use. • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. • Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with ABRILADA prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with ABRILADA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products [see Warnings and Precautions (5.2) ] . Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants [see Warnings and Precautions (5.2) ] . WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): • Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. • Discontinue ABRILADA if a patient develops a serious infection or sepsis during treatment. • Perform test for latent TB; if positive, start treatment for TB prior to starting ABRILADA. • Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY ( 5.2 ): • Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. • Post‑marketing cases of hepatosplenic T‑cell lymphoma (HSTCL), a rare type of T‑cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products.
Common side effects
- HEADACHE
- COLITIS ULCERATIVE
- PYREXIA
- NASOPHARYNGITIS
- PHARYNGITIS
- ANAEMIA
- ABDOMINAL PAIN UPPER
- PERIPHERAL SWELLING
- ARTHRALGIA
- OROPHARYNGEAL PAIN
- NEUTROPENIA
- THROMBOCYTOSIS
Drug interactions
- Abatacept
- Anakinra
- Live vaccines
- Methotrexate
- CYP450 substrates
Key clinical trials
- Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |