Exemptia 40 mg PFS

Dosing Information:

Administered by subcutaneous injection
Dose for Rheumatoid Arthritis (RA), Psoriatic Arthritis, Ankylosing Spondylitis:
40 mg every other week
Some patients with RA not receiving methotrexate may benefit from increasing the frequency to 40 mg every week.
Dose for Juvenile Idiopathic Arthritis:
10 kg to < 15 kg: 10 mg every other week
15 kg to < 30 kg: 20 mg every other week
? 30 kg: 40 mg every other week

How it 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.). EXEMPTIATM (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, EXEMPTIATM helps reduce the damaging effects of excess TNF. Remember no treatment can stop your body's overproduction of TNF, but a medication like EXEMPTIATM can help reduce its effects.

The pain, stiffness, and swelling of rheumatoid arthritis can make it difficult for you to perform daily activities such as:
Combing your hair
Buttoning a shirt
Opening a jar
Walking up stairs
For many adults, EXEMPTIATM is proven to help reduce pain, reduce joint swelling and stiffness, and help stop further joint damage. EXEMPTIATM is a prescription medicine used alone, with methotrexate, or with certain other medicines to reduce the signs and symptoms of moderate to severe rheumatoid arthritis in adults, may prevent further damage to your bones and joints, and may help in increasing your ability to perform daily activities. EXEMPTIATM works by targeting and blocking a specific source of inflammation that contributes to symptoms of rheumatoid arthritis.

RESULTS:

Clinical Trial of EXEMPTIATM in Indian Patients:

Globally Adalimumab is available as HUMIRA. A clinical study was conducted in India to assess if efficacy and safety of EXEMPTIATM is similar to HUMIRA 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. EXEMPTIATM and Innovator's Adalimumab. This trial was conducted for a period of 12 weeks.

How well did EXEMPTIATM work in this trial?

After treatment with EXEMPTIATM, 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 EXEMPTIATM in this trial?

Overall, EXEMPTIATM was safe and well tolerated in this study. The safety profile of both EXEMPTIATM and HUMIRA was similar.

What were the commonly observed side- effects with EXEMPTIATM in this trial?

Dyspnoea (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, Diarrhoea 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.