Actemra was more effective than Humira in reducing tender and swollen joints and other measures of rheumatoid arthritis in patients who couldn’t take methotrexate, the usual initial treatment for the disease, the Basel, Switzerland-based drugmaker said. Roche presents the study today at the European League Against Rheumatism’s annual conference in Berlin.
The results may influence doctors to prescribe Actemra instead of Humira for the roughly 30 percent of patients who need a single-drug treatment, said Karsten Jung, Roche’s therapeutic area head for immunology. Roche and Abbott Park, Illinois-based Abbott may face competition soon if U.S. regulators approve Pfizer Inc. (PFE)’s rheumatoid arthritis pill tofacitinib.
“This will make a strong case that this should set Actemra apart from other medications,” Jung said in a telephone interview.
Roche believes annual sales of Actemra may peak at more than 1 billion Swiss francs ($1.03 billion), Jung said. The Swiss drugmaker hopes to get U.S. Food and Drug Administration approval this year to sell Actemra for patients who haven’t already tried Humira or a similar biological treatment, instead of only those who aren’t helped by those medicines, he said.
Sold as RoActemra in Europe, the Roche drug had 618 million francs in sales last year. Sales rose about 46 percent to 184 million francs in the first quarter.
By comparison, Humira sales reached $7.9 billion last year. New York-based Pfizer’s tofacitinib, recommended for approval by a U.S. advisory panel last month, may generate $1.5 billion annually by 2020, analysts at Citigroup Inc. said.
“The study evaluated monotherapy treatment using the maximum Actemra dose and the minimum Humira dose allowed for monotherapy, so the results may be skewed in favor of Actemra,” Raquel Powers, an Abbott spokeswoman, said in a telephone interview.
Doctors will make a decision on Actemra based on the balance between the drug’s toxicity and potential benefit, EULAR President Maxime Dougados said in a telephone interview.
“It’s good to have this information,” Dougados said. “I’m not sure it will radically change the management style tomorrow morning.”
Roche rose 1.3 percent to 151.40 Swiss francs at 2:40 p.m. in Zurich trading
In today’s Roche study, about 65 percent of the patients who took Actemra showed a 20 percent improvement after six months, compared with about 49 percent of the patients who took Humira.
More patients who took Actemra saw their cholesterol rise than among the Humira group, according to the study. Serious infections were about the same between groups.
In a second study released at the Berlin conference today, Bristol-Myers Squibb Co. (BMY)’s therapy Orencia was about equal to Humira in patients who hadn’t taken a biological rheumatoid arthritis treatment before. After a year of treatment, about 65 percent of the patients on Orencia showed a 20 percent improvement, compared with about 63 percent of patients on Humira. The patients took the biological medicines together with methotrexate.
Rheumatoid arthritis usually hits adults between 20 and 40 years of age, as the immune system attacks the joints to cause swelling, pain and damage that can lead to deformity and disability. More common in women than in men, the disease afflicts about 1.3 million Americans, according to the National Institutes of Health.
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