one of seven cohorts with about 60 people each. One group got a placebo plus methotrexate (a common generic immune suppressor), and another group got AbbVie’s adalimumab (Humira) with methotrexate. The other patients got the new Bristol-Myers/Alder drug in either a 25 mg, 100 mg, or 200 mg form, with or without methotrexate.
Here’s what researchers found: Patients appeared to do the best on the lowest dose (25 milligrams) of the Bristol-Myers/Alder drug. The drug met the study’s main goal, by showing it could help many more patients achieve a 20 percent reduction in the signs and symptoms of rheumatoid arthritis, as measured by the standard ACR20 scoring system after 12 weeks. About 78 percent of patients on the low 25 milligram dose of Bristol-Alder’s claza and methotrexate reached the ACR20 threshold, while 39.3 percent did that well on methotrexate and a placebo. The new drug performed almost identically to the existing product sold by AbbVie. About 76.3 percent of patients reached the ACR20 goal on the standard 40 mg dose of the AbbVie drug and methotrexate.
While the primary goal of the study is always important to watch, researchers also looked at a number of important secondary goals. They looked at the number of patients who had a 50 percent reduction in their signs and symptoms (ACR50) and the number who did truly fantastic, achieving a 70 percent reduction (ACR70). As readers can see from the study abstract, the Bristol-Myers/Alder drug was again very similar to the AbbVie drug on the ACR50 score (47.5 percent compared with 49.2 percent), and appeared to have a slight advantage on the ACR70 score (27.1 percent to 18.6 percent). The Bristol-Myers/Alder drug appeared to have some more advantage on a couple different ways of measuring disease remission, particularly what’s known as Disease Activity Score 28 (DAS28), which measures levels of C-reactive protein in the blood.
The new biotech drugs that work by blunting an excessive immune reaction are also associated with an increased risk of infection, so that is something researchers always look carefully at in clinical trials. The most common side effects associated with the new drug were dose-related injection site reactions that ranged from 32.2 percent of patients up to 63.3 percent of patients, according to a Bristol-Myers statement. Between 1.7 and 5.1 percent of patients on various doses of the new drug reported serious infections during the study, compared with none in the methotrexate-only group, and 3.4 percent who got the AbbVie drug and methotrexate. Patients on the new drug also saw increases in their total cholesterol scores, although that’s a predictable effect based on IL-6 inhibition, Garg said. Bristol-Myers didn’t say how much the cholesterol scores went up.
Bristol-Myers also didn’t say in today’s statement what its next move will be in clinical development. Garg said the company is going through the data “with a fine-tooth comb” to map out its next steps in clinical trials. But he suggested the drug clearly has a future in Phase III clinical trials, the largest and most expensive stage of development before FDA approval. The new IL-6 inhibitor, he said, could end up “building on the foundation we’ve built” with abatacept (Orencia), which works against rheumatoid arthritis through a different scientific mechanism, by blocking T-cell co-stimulation.
“We’re very excited about the results with claza, and we’re mapping out next steps,” Garg said.
