Exemptia (adalimumab) is a prescription medicine that can be self-injected. It is used to treat moderate to severe rheumatoid arthritis (RA). Exemptia (adalimumab) is grouped within a class of medications called biologic response modifiers, or biologics. By working on the immune system, biologics block proteins that contribute to the disease process. Because Exemptia (adalimumab) suppresses the immune system, patients are at a greater risk for getting serious infections.
The science behind Exemptia (adalimumab)
Tumor necrosis factor (TNF) is a substance made by your body’s immune system. People with inflammatory diseases such as rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, juvenile idiopathic arthritis and ankylosing spondylitis have too much TNF in their bodies. Exemptia (adalimumab) reduces levels of the active form of TNF.
How Exemptia works?
Usually, your immune system protects your body from many of the things that can be harmful. But when the immune system doesn’t work properly, it can attack one’s own healthy tissues and organs. This is an autoimmune disorder. A protein called as tumor necrosis factor, also known as TNF, produced naturally by the body is one part of your immune system. But in certain autoimmune diseases, some people produce too much TNF. This often leads to inflammation (Inflammation is the body’s attempt at self-protection; the aim being to remove harmful stimuli, including damaged cells, irritants, or pathogens – and begin the healing process. However, sometimes inflammation can cause further inflammation; it can become self-perpetuating.). Exemptia (contains adalimumab) is a medication called a TNF blocker. It works by binding to TNF molecules and blocking them from attaching to and attacking healthy cells. In this way, Exemptia (adalimumab) helps reduce the damaging effects of excess TNF. Remember no treatment can stop your body’s overproduction of TNF, but a medication like Exemptia (adalimumab) can help reduce its effects.
Mechanism of Action (MoA) of Exemptia
Exemptia (adalimumab) works by targeting and blocking a specific source of inflammation that contributes to symptoms of rheumatoid arthritis.
Results with Exemptia
Clinical Trial of Exemptia in Indian Patients:
A clinical study was conducted in India to assess if efficacy and safety of Exemptia (adalimumab Biosimilar). A total 162 subjects were screened at 11 investigational sites in India, of which, 120 subjects were enrolled in the study, 60 subjects in each group viz. Exemptia (adalimumab) and Innovator’s Adalimumab. This trial was conducted for a period of 12 weeks.
How well did Exemptia work in this trial?
After treatment with Exemptia (adalimumab), at Visit 5 (on day 84), 82% patients had 20% improvement in rheumatoid arthritis (RA) symptoms, 46% patients had 50% improvement in RA symptoms and 14% patients had 70% improvement in RA symptoms. These results were similar to those with Innovator’s Adalimumab.
How safe was Exemptia in this trial?
Overall, Exemptia was safe and well tolerated in this study. The safety profile of both Exemptia and Originator Adalimumab was similar.
What were the commonly observed side- effects with Exemptia in this trial?
Dyspnea (difficulty in breathing), Fungal infection, Gastritis, Headache, Injection site reaction, Oligomenorrhoea(menstrual periods occur at intervals of greater than 35 days, with only four to nine periods in a year), Pollakiuria(an excessive frequent urination), Polymenorrhoea (occurrence of menstrual cycles at frequency that is higher than normal), Pulmonary tuberculosis, Fever, Rash, Urinary tract infection, Vomiting, Abdominal discomfort, Abdominal pain, Accelerated hypertension (rapid and sudden increase in blood pressure ), Asthenia (abnormal physical weakness), Chest pain, Cough, Diarrhea and Dyspepsia (indigestion) Majority of adverse events were mild in intensity and not related to the study drug. There were no persistent changes from baseline in laboratory parameters in both treatment groups.
Do not try to inject Exemptia (adalimumab) yourself until you have been shown the right way to give the injections and have read and understood this Instructions for Use.
Adalimumab Injection administered by subcutaneous injection.