Fifteen deaths links to Actemra (tocilizumab) have cast a cloud over Roche's first-in-class anti-inflammatory drug. Actemra, a monoclonal antibody targeting the interleukin-6 receptor, has been licensed as a rheumatoid arthritis treatment in Japan since early 2008 and touted as a potential blockbuster for the Basel-based Swiss company. Now, Roche's Tokyo-based partner, Chugai Pharmaceutical has reported that 221 patients among 4,915 taking the drug in Japan, in the year ending February, suffered serious side effects including pneumonia and severe fever, and 15 died. The company stressed that the death rate was at the same levels as in clinical trials and similar to competing medications. Chris Deighton, a consultant rheumatologist at Derbyshire Royal Infirmary, in Derby, UK says, “it's premature to be writing the obituary for Actemra,” as severe rheumatoid arthritis is a disease with an intrinsically high mortality rate. Tumor necrosis factor blockers, such as Enbrel (etanercept) and Remicade (infliximab), although standard rheumatoid arthritis treatments, also have risks such as increased rates of tuberculosis and cancer and are not suitable for all patients. “We can't be complacent about these results,” says Deighton about Actemra's side effects, “but we still need a lot more information.” If Actemra is deemed unsafe, cautions Deighton, doctors will opt for other medications. Actemra was recently approved by the European Medicines Agency, but has not yet been licensed by the US Food and Drug Administration. In April, Genentech announced the voluntary withdrawal of its psoriasis drug Raptiva (efalizumab) from the US market because of confirmed links to brain infection. Raptiva has been associated with the rare and usually fatal progressive multifocal leukoencephalopathy. In Europe and Canada, where the drug is marketed by Geneva-based Merck Serono and Serono of Mississauga, Ontario, respectively, regulators had taken Raptiva off the market in February (Nat. Biotechnol. 27, 303, 2009).