Adalimumab is a complex molecule, a synthetically produced monoclonal antibody. It is a drug that is not available for purchase without a prescription.
It appears as a liquid that is not soluble in water, but in specific buffer solutions.
It is produced using recombinant DNA technology and the specific production process may vary depending on the system used (bacteria, mammalian cells). Generally, the following route is used:
- Identification and isolation of the gene encoding the amino acid sequence of Adalimumab
- Insertion of the gene into an expression vector (a DNA fragment)
- Introduction of the vector containing the gene into host cells (bacteria, mammalian cells).
- Transformation of host cells and start of Adalimumab production.
- Purification of Adalimumab, which is extracted from the culture broth or host cells to remove impurities.
- The last link in the pathway is quality control, which guarantees the desired biological activity, the absence of impurities. This pathway may vary depending on regulations, from country to country.
What it is used for and where
Medical
Take only under medical supervision
Adalimumab as a biological drug is intended to treat specific targets in the human body such as inflammatory autoimmune diseases of the immune system, for example:
- Ankylosing spondylitis
- Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
- Crohn's disease
- Enthesitis-related arthritis
- Hidradenitis suppurativa
- Non-infectious uveitis
- Plaque psoriasis
- Polyarticular juvenile idiopathic arthritis
- Psoriatic arthritis
- Rheumatoid arthritis
- Ulcerative colitis
Like all drugs it can cause side effects. Always ask the physician.
Commercially, it is sold under the name Humira.
Molecular Formula C6428H9912N1694O1987S46
Humira leaflet (UK)
References_____________________________________________________________________
Maccora I, dell'Anna MP, Vannacci A, Simonini G. Safety evaluations of adalimumab for childhood chronic rheumatic diseases. Expert Opin Drug Saf. 2020 Jun;19(6):661-671. doi: 10.1080/14740338.2020.1763300.
Abstract. Introduction: Childhood rheumatic diseases (CRD) are chronic inflammatory conditions, often leading to severe functional impairment and disability. They produce high direct and indirect costs for patients, their families and society overall. Biologic treatment, adalimumab of note, has drastically changed the disease management, significantly decreasing morbidity, over childhood, and eventually lifelong. After 12 years of pediatric experience with adalimumab, safety data resulted of great interest. Areas covered: This review summarizes published knowledge about safety of adalimumab in clinical trials and real-life setting studies. Infections and site injection reactions are considered the most frequent adverse events, but the occurrence of second autoimmune diseases as well as malignancy development are the two major concerns of the medical community and families. Expert opinion: Adalimumab has revolutionized treatment and prognosis of most of CRD, resulting in good outcomes with highly acceptable safety profile. Number and type of entered adverse events differ from clinical trials and registries, these latter mirroring clinical real life. Different temporal observations and sample cohorts mainly account of this discrepancy. Both randomized clinical trials and real-world data are complementary. Clinical trials coupled with long-term registries will help to improve the evidence-based safety for children with CRD.
Zhao S, Chadwick L, Mysler E, Moots RJ. Review of Biosimilar Trials and Data on Adalimumab in Rheumatoid Arthritis. Curr Rheumatol Rep. 2018 Aug 9;20(10):57. doi: 10.1007/s11926-018-0769-6.
Abstract. Purpose of review: Adalimumab is one of the top-selling drugs worldwide. Its imminent patent expiration has seen the emergence of numerous biosimilar agents. In this article, we recap the evidence from bio-originator trials in rheumatoid arthritis (RA) to provide context for a critical review of biosimilar trial data. Recent findings: Currently, three adalimumab biosimilars are approved in Europe and/or the USA: Amgen's ABP 501 (AMJEVITA/Solymbic), Boehringer Ingelheim's BI 695501 (Cyltezo) and Samsung Bioepis's SB5 (Imraldi). All three agents met their pre-specified equivalence criteria. Subtle differences in adverse events and clinical responses between the reference and biosimilar products were noted. The introduction of adalimumab biosimilars will offer exciting opportunities in improving treatment access and increasing treatment options for RA and other licensed indications. Real-world data will further provide assurances on efficacy as well as safety.
Jaffe GJ, Dick AD, Brézin AP, Nguyen QD, Thorne JE, Kestelyn P, Barisani-Asenbauer T, Franco P, Heiligenhaus A, Scales D, Chu DS, Camez A, Kwatra NV, Song AP, Kron M, Tari S, Suhler EB. Adalimumab in Patients with Active Noninfectious Uveitis. N Engl J Med. 2016 Sep 8;375(10):932-43. doi: 10.1056/NEJMoa1509852.
Abstract. Background: Patients with noninfectious uveitis are at risk for long-term complications of uncontrolled inflammation, as well as for the adverse effects of long-term glucocorticoid therapy. We conducted a trial to assess the efficacy and safety of adalimumab as a glucocorticoid-sparing agent for the treatment of noninfectious uveitis. Methods: This multinational phase 3 trial involved adults who had active noninfectious intermediate uveitis, posterior uveitis, or panuveitis despite having received prednisone treatment for 2 or more weeks. Investigators and patients were unaware of the study-group assignments. Patients were randomly assigned in a 1:1 ratio to receive adalimumab (a loading dose of 80 mg followed by a dose of 40 mg every 2 weeks) or matched placebo. All patients received a mandatory prednisone burst followed by tapering of prednisone over the course of 15 weeks. The primary efficacy end point was the time to treatment failure occurring at or after week 6. Treatment failure was a multicomponent outcome that was based on assessment of new inflammatory lesions, best corrected visual acuity, anterior chamber cell grade, and vitreous haze grade. Nine ranked secondary efficacy end points were assessed, and adverse events were reported. Results: The median time to treatment failure was 24 weeks in the adalimumab group and 13 weeks in the placebo group. Among the 217 patients in the intention-to-treat population, those receiving adalimumab were less likely than those in the placebo group to have treatment failure (hazard ratio, 0.50; 95% confidence interval, 0.36 to 0.70; P<0.001). Outcomes with regard to three secondary end points (change in anterior chamber cell grade, change in vitreous haze grade, and change in best corrected visual acuity) were significantly better in the adalimumab group than in the placebo group. Adverse events and serious adverse events were reported more frequently among patients who received adalimumab (1052.4 vs. 971.7 adverse events and 28.8 vs. 13.6 serious adverse events per 100 person-years).
Bechara FG, Podda M, Prens EP, Horváth B, Giamarellos-Bourboulis EJ, Alavi A, Szepietowski JC, Kirby J, Geng Z, Jean C, Jemec GBE, Zouboulis CC. Efficacy and Safety of Adalimumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa: The SHARPS Randomized Clinical Trial. JAMA Surg. 2021 Nov 1;156(11):1001-1009. doi: 10.1001/jamasurg.2021.3655.
Abstract. Importance: Surgery is a mainstay in the management of hidradenitis suppurativa (HS). Adalimumab is the first drug approved for HS. Objective: To investigate the efficacy and safety of adalimumab in combination with wide-excision surgery followed by secondary intention healing... Conclusions and relevance: Adalimumab was efficacious in conjunction with wide-excision surgery followed by secondary intention healing, with no need to interrupt treatment prior to surgery. These data support further investigation of adalimumab as an adjuvant therapy to surgery in patients with moderate to severe HS.
Duquenne L, Gul H, Emery P. Safety evaluation of adalimumab in immune-mediated inflammatory disorders: a rheumatological point of view. Expert Opin Drug Saf. 2019 Jan;18(1):11-19. doi: 10.1080/14740338.2018.1549541.
Abstract. Immune-mediated inflammatory disorders (IMIDs) are systemic conditions which arise secondary to complex immune mechanism defects and can affect many organs. While previous therapies based on steroids and immunosuppressive agents had a poor risk/benefit balance, TNFα-specific inhibitors such as adalimumab have revolutionized the course of many diseases and patient outcomes. However, concerns were raised regarding the increased risk of infectious diseases and neoplasia due to potential prospective loss of immune control. This is especially true when considering that IMIDs concerns elderly/frail populations, with multiple co-morbidities, organ damage and often long-term steroid therapy. Areas covered: Now prescribed for more than 15 years for a diverse range of indications, long-term data highlighting the efficacy and safety are available and led to recommendations for the daily practice that will be discussed. Expert opinion: The efficacy of adalimumab changed the therapeutic paradigm of many diseases. Its tolerance is good and it is the most widely prescribed therapy in IMIDs. It is now the standard of care arm in head to head trials. In the long term, adalimumab dominant role might be weakened by more targeted therapies but its varied indications among IMIDs should secure its position as an important tool in our future practice.
Yiu ZZN, Becher G, Kirby B, Laws P, Reynolds NJ, Smith CH, Warren RB, Griffiths CEM; BADBIR Study Group. Drug Survival Associated With Effectiveness and Safety of Treatment With Guselkumab, Ixekizumab, Secukinumab, Ustekinumab, and Adalimumab in Patients With Psoriasis. JAMA Dermatol. 2022 Oct 1;158(10):1131-1141. doi: 10.1001/jamadermatol.2022.2909.
Abstract. Importance: Drug survival of biologic therapies for psoriasis is a proxy for longer-term treatment effectiveness and safety. Patient factors that are associated with the survival of each biologic differently (effect modifiers) may inform the decision to choose between biologics. Objective: To assess the drug survival associated with the effectiveness and safety of commonly used biologics for psoriasis in the UK and Ireland and identify effect modifiers for these biologics and their survival. Design, setting, and participants: We conducted a prospective cohort study of patients with psoriasis using data from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR) between November 2007 and August 2021. Exposures: Adalimumab, ustekinumab, secukinumab, guselkumab, ixekizumab. Main outcomes and measures: We conducted a survival analysis and fitted separate flexible parametric models for drug survival as a proxy for effectiveness and safety.....Conclusions and relevance: The results of this cohort study suggest that guselkumab had the highest drug survival in BADBIR of the included biologics for treatment persistence that was associated with effectiveness, and guselkumab had highest drug survival for safety compared with other biologics except ustekinumab. Psoriatic arthritis, nail involvement, previous biologic exposure, and ethnicity were effect modifiers for biologics and their survival in association with treatment effectiveness. This information on longer-term treatment persistence, safety, and tolerability may help patients and their clinicians make an informed decision to initiate treatment with a biologic therapy.
