A drug being developed jointly by Johnson & Johnson (NYSE:JNJ) and GlaxoSmithKline PLC (NYSE:GSK) met endpoints in a large Phase 3 study that enrolled 1,670 patients. The drug candidate called sirukumab is aimed at people suffering from rheumatoid arthritis and the positive late-stage data means that the developers have edged closer to its commercialization.
According to Johnson & Johnson and GSK, patients who received sirukumab treatment demonstrated significant improvement in their disease condition compared to the control group that received a placebo. Rheumatoid arthritis is characterized by joint damage caused by autoimmunity. Patients on sirukumab during the Phase 3 study not only exhibited less joint erosion, but their joint space also significantly narrowed.
Change in joint damage
Johnson & Johnson and GSK researchers used a scoring method to determine changes in joint damage. When viewed by the aid of X-ray, a higher score indicates greater joint damage. The patients who took a placebo exhibited a score of 3.69 compared to a score of 0.50 for the patients who took 50mg of sirukumab and a score of 0.46 for those who received 100mg of the drug.
The changes in joint structure were noted in patients who took the 50mg dose every four weeks and those who took the 100mg dose every two weeks.
Improvement in disease symptoms
According to both companies, 54.8% of the patients in the 50mg dose group registered at least 20% improvement in the disease signs and symptoms they experienced. In the group that received the 100mg dose, 53.5% of them showed more than 20% improvement in their disease condition. In contrast, just 26.4% of the placebo group exhibited an improvement in their disease symptoms.
On the average, at least 30% of all the patients who received sirukumab demonstrated 50% improvement in their disease condition.
Johnson & Johnson and GSK researchers will present the data in London at the weekend during a European rheumatology meeting.