At a glance......
- 0.1 Dosage forms
- 0.2 Indication
- 0.3 What side effects can this medication cause?
- 0.3.1 Adalimumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- 1 Adalimumab biosimilar exhibits same efficacy and safety for rheumatoid arthritis as originator
Adalimumab is a medication used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, chronic psoriasis, hidradenitis suppurativa, and juvenile idiopathic arthritis. In rheumatoid arthritis, adalimumab has a response rate similar to methotrexate, and in combination, it nearly doubles the response rate of methotrexate alone.
Adalimumab is a TNF-inhibiting, anti-inflammatory, biologic medication. It binds to tumor necrosis factor-alpha (TNFα), which normally binds to TNFα receptors, leading to the inflammatory response of autoimmune diseases. By binding to TNFα, adalimumab reduces this inflammatory response. Because TNFα is also part of the immune system, which protects the body from infection, treatment with adalimumab may increase the risk of infections.
HUMIRA is a prescription medicine used:
- To reduce the signs and symptoms of:
- Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
- Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines.
- Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
- Ankylosing spondylitis (AS) in adults.
- Moderate to severe Crohn’s disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to certain other medications. HUMIRA is also used to reduce signs and symptoms and to achieve clinical remission in these adults who have lost response to or are unable to tolerate infliximab.
- Moderate to severe Crohn’s disease (CD) and to achieve and maintain clinical remission in children 6 years of age and older when certain other treatments have not worked well enough.
- Moderate to severe hidradenitis suppurativa (HS) in adults.
- In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
- To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
- To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye) and panuveitis (all parts of the eye) (UV) in adults.
What side effects can this medication cause?
Adalimumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- redness, itching, bruising, pain, or swelling in the place you injected adalimumab injection
- back pain
Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency care:
- numbness or tingling
- problems with vision
- weakness in legs
- chest pain
- shortness of breath
- rash, especially a rash on the cheeks or arms that is sensitive to sunlight
- new joint pain
- swelling of the face, feet, ankles, or lower legs
- difficulty breathing or swallowing
- fever, sore throat, chills, and other signs of infection
- unusual bruising or bleeding
- pale skin
- red, scaly patches or pus-filled bumps on the skin
Adults who receive adalimumab injection may be more likely to develop skin cancer, lymphoma, and other types of cancer than people who do not receive adalimumab injection. Talk to your doctor about the risks of receiving this medication.
Adalimumab injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
Adalimumab biosimilar exhibits same efficacy and safety for rheumatoid arthritis as originator
The trial data was presented at the American College of Rheumatology / Association of Rheumatology Health Professionals Annual Meeting in San Diego, California by the manufacturers of Cyltezo.
Patients with rheumatoid arthritis (RA) who switched from adalimumab (Humira) to its biosimilar, adalimumab-adbm (Cyltezo), saw no clinically meaningful difference in efficacy, safety or immunogenicity, according to the results of a 48-week Phase III clinical trial.
The trial data was presented at the American College of Rheumatology / Association of Rheumatology Health Professionals Annual Meeting in San Diego, California by Boehringer Ingelheim, the manufacturers of Cyltezo.
The study, which aimed to assess equivalence in efficacy between the two drugs, comprised 645 patients aged 18 to 80 years with moderate-to-severely active RA on stable treatment with methotrexate. The patients were randomised to receive either adalimumab or its biosimilar, adalimumab-adbm, at 40mg every two weeks for 48 weeks.
At week 24, those patients receiving adalimumab were re-randomised to switch to the biosimilar or continue with adalimumab until week 48.
At week 48, it was found that adalimumab and its biosimilar had similar efficacy, safety and immunogenicity. In addition, those patients who switched at week 24 showed no difference to those who had continued with adalimumab.
“These data are an important addition to the robust body of evidence demonstrating Cyltezo is biosimilar to Humira,” said Karsten Kissel, head of global medical affairs biosimilars at Boehringer Ingelheim.
“Biosimilars have potential cost benefits to the healthcare system and support affordable access to important biologic medicines for patients living with chronic inflammatory diseases like RA,” he added.
In the European Union, adalimumab-adbm recently received positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency for multiple chronic inflammatory diseases in adults, including moderate to severely active RA; psoriatic arthritis; moderate to severely active Crohn’s disease; and moderate to severely active ulcerative colitis.
It is not currently commercially available in the United States.
- Certolizumab pegol