| gical response modifiers (BRMS) are drugs that target | | | | (either 4mg/kg or 8mg/kg) every four weeks plus |
| inflammatory pathways in rheumatoid arthritis (RA) and | | | | methotrexate weekly or placebo infusions plus |
| represent a relatively new approach to the treatment | | | | methotrexate weekly. The study was conducted in 73 |
| of RA. | | | | trial sites in 17 countries outside the United States. |
| Medications that block tumor necrosis factor alpha | | | | A rapid decrease in disease activity was seen as |
| (TNF-a), a pro-inflammatory cytokine important in the | | | | early as two weeks in a greater proportion of patients |
| pathogenesis of RA, were among the first to be | | | | treated with Actemra plus methotrexate, with 27.5% |
| developed and approved for the treatment of RA. | | | | achieving clinical remission by 24 weeks. |
| Several anti-TNF-a medications including Enbrel, Humira, | | | | Additionally, results showed that 80% of patients in the |
| and Remicade are currently marketed for the | | | | Actemra plus methotrexate group responded with |
| treatment of RA. | | | | moderate to good improvements in RA symptoms, |
| Actemra (tocilizumab) differs from currently marketed | | | | compared with 35% for those treated with placebo |
| biological response modifiers that block TNF-a, since it | | | | and methotrexate at 24 weeks. |
| targets interleukin-6 (IL-6), a cytokine that is also | | | | The OPTION trial also assessed physical function and |
| over-produced in the joints of RA patients. | | | | quality-of-life at baseline and every four weeks |
| Il-6 is believed to contribute to inflammation, swelling | | | | thereafter. Patients receiving Actemra achieved |
| and joint damage and possibly the anemia and platelet | | | | significantly greater improvement in areas of fatigue |
| elevation counts seen in RA. | | | | and mental function at 24 weeks, and achieved normal |
| Actemra is a humanized anti-human IL-6 receptor | | | | levels of hemoglobin (red blood cell count)and |
| monoclonal antibody that works by competitively | | | | C-reactive protein (CRP), a marker of inflammation |
| blocking the binding of IL-6 to its receptor. In essence, it | | | | due to RA, compared with patients receiving placebo |
| inhibits the deleterious effects of IL-6, which lead to | | | | plus methotrexate. In addition, platelets, blood cells that |
| inflammation and proliferation of inflammatory cells and | | | | often increase in number during the inflammation that |
| the destructive organ potential in RA. | | | | accompanies RA, seemed to drop as well. |
| Multiple clinical trials have examined the efficacy and | | | | According to Dr. Nathan Wei, “The advantage |
| safety of Actemra. | | | | of Actemra is that it offers treating rheumatologists |
| The largest of these trials was the OPTION | | | | another weapon in our arsenal for treating rheumatoid |
| (TOcilizumab Pivotal Trial in Methotrexate Inadequate | | | | arthritis. Nowadays, it is my expectation that when I |
| RespONders), a three-arm, randomized, double-blind, | | | | see a patient with rheumatoid arthritis, I can count on |
| controlled study designed to compare the safety and | | | | getting them into remission. It may be only a short time |
| efficacy of Actemra plus methotrexate with | | | | into the future that we will be able to cure this |
| methotrexate plus placebo in RA patients who had an | | | | disease.” |
| inadequate response to methotrexate alone. | | | | Roche, the manufacturer of Actemra in the United |
| Results from the OPTION trial demonstrated that | | | | States, announced that the Arthritis Advisory |
| rheumatoid arthritis (RA) patients not only achieved | | | | Committee of the U.S. Food and Drug Administration |
| greater improvement of symptoms but also a higher | | | | (FDA) by a near unanimous (10-1) vote recommended |
| quality-of-life with Actemra compared with | | | | approval of Actemra (tocilizumab), a novel interleukin-6 |
| methotrexate, a commonly used RA treatment. | | | | (IL-6) receptor-inhibiting monoclonal antibody, for |
| In the OPTION trial, which was a three-arm, | | | | reducing the signs and symptoms in adults with |
| double-blind, controlled Phase III study, 623 patients | | | | moderate to severe rheumatoid arthritis (RA). |
| were randomized to receive Actemra intravenously | | | | |