Adding Tofacitinib to standard treatment has been shown to be more effective than standard rheumatoid arthritis treatment alone, according to top-line results of two Phase 3 Trials, pharmaceutical giant Pfizer announced. The company says results details will be presented at a future scientific meeting.
The two trials were called ORAL Standard and ORAL Step.
The Oral Standard 12-month trial involved 717 patients with moderate-severe rheumatoid arthritis (RA) symptoms who did not respond properly to methotrexate – they were randomly selected to receive either tofacitinib 5 or 10 mg twice a day, adalimumab 40 mg subcutaneously every two weeks or a placebo – in both cases the patient was also on standard methotrexate therapy. The study met all primary endpoints (main goals), demonstrating considerable changes compared to placebo in alleviating RA signs and symptoms.
The Oral Step 6-month trial involved 399 patients with moderate-severe RA who had not responded properly to a TNF inhibitor. They were randomly selected to receive either tofacitinib 5 or 10 mg twice a day or a placebo, – in both cases the patient was also on standard methotrexate therapy. This study also met all its primary endpoints.
Neither of the two trials reported any new safety signals. Safety and efficacy data regarding tofacitinib in both studies are no different from what was reported in previous studies.
Rheumatoid arthritis, also known as rheumatoid disease is a long-lasting (chronic), disabling and progressive autoimmune disease. The patient experiences swelling and pain in the joints, inflammation and pain in the tissue surrounding joints, as well as other organs. In most cases, signs and symptoms appear initially in the hands and feet – however, any joint might be affected. Patients typically feel tired and generally unwell, and have stiff joints.
Rheumatoid arthritis is a systemic illness – it affects the whole body – often multiple organs may have symptoms. There may be fever, extreme fatigue, the inflammation can spread into the lungs and the pleura (membrane around the lungs, the pericardium and the sclera (the white outer coat of the eyeball). There may also be nodular lesions under the skin.
Rheumatoid arthritis is much more common in women than in men. It is much more common in smokers. The John Hopkins Arthritis Center, USA, says that about 1% to 2% of people worldwide are affected by RA. Nearly 5% of females aged at least 55 years have RA. In the USA, 70 people in every 100,000 has RA.
Industry experts say that Pfizer would like tofacitinib to become an oral alternative to existing injected or intravenous medications, including Humira (Abbot Laboratories). Tofacitinib could generate sales up to $2 billion. Pfizer hopes tofacitinib will make up for the expected loss in revenue when generic competition for Lipitor arrives at the end of this year.
Written by Christian Nordqvist