Counseling Points - December 2008 - (Page 8)

received tocilizumab 4 mg or 8 mg/kg achieved an ACR20 response than patients taking placebo (48% and 59% versus 26%, respectively). 16 There was also a significant decrease in swollen and tender joint counts and rapid and sustained decreases in inflammation markers such as ESR and CRP.16 Hemoglobin levels increased in both tocilizumab groups, but not in the placebo group. (Low hemoglobin concentrations typically are associated with severe and chronic inflammation and are often seen in persons with autoimmune diseases). In addition, tocilizumab patients versus placebo patients experienced clinically meaningful increases in health-related quality of life demonstrated by improvements from baseline in the Health Assessment Questionnaire Disease Index (HAQ-DI), physical and mental components of the short form 36-item (SF-36) survey, and the Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) scale.16 Because early and aggressive treatment of rheumatic diseases is important in improving long-term outcomes, there is a need for targeted patient education. Tocilizumab was generally well tolerated, but more patients receiving 4 mg/kg or 8 mg/kg doses of the active study drug reported at least one adverse event compared with placebo patients (71% and 69% versus 63%, respectively). Upper respiratory infection was the most commonly occurring adverse event reported in tocilizumab patients. The incidence of serious adverse events, such as pneumonia, hypersensitive reactions, and infections, was similar among all treatment groups.16 The tocilizumab cohort also demonstrated slight increases in colon perforations. Additionally, tocilizumab versus placebo patients had a higher rate of elevated cholesterol levels (23% versus 4.8%) and 3to 5-fold increases in liver enzymes.16 This seems somewhat logical given the fact that liver cells are particularly rich in IL-6 receptors. While the liver enzyme elevation was noted to be transient in most cases, the cholesterol elevations tended to be chronic. Therefore, it is currently recommended that clinicians obtain complete blood count (CBC) and chemistry panels monthly for tocilizumab patients. Baseline cholesterol should be documented and cholesterol-lowering medications should be considered if needed.16 cules, such as adenotriphosphate (ATP), to a recipient molecule.1 Nearly 520 unique kinases have currently been recognized. One specific set of kinases, Janus kinase (JAK), bears two almost-identical phosphate-transferring domains, one that exhibits kinase activity and another that negatively regulates that activity.17 Recent evidence suggests that JAK mediates multiple signaling pathways used by cytokines and growth factors involved in a number of diseases, including RA.17 The novel JAK inhibitor INCB018424 from Incyte Corporation is currently being studied as an oral treatment for RA.18 This agent is greater than 100-fold selective against a broad panel of kinases. 18 Recently released results from a 28-day, double-blind, placebo-controlled, phase-2b study in 50 RA patients were presented at the 2008 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Scientific Meeting.18 In this study, four doses of INCB018424 (5 mg BID, 15 mg BID, 25 mg BID, and 50 mg QD) were assessed. ACR20/50/70 response rates for placebo and the INCB018424 5-mg BID dose group were similar.18 However, patients receiving the three higher doses achieved ACR20 response rates of 50% to 83%, ACR50 rates of 40% to 50%, ACR70 rates of 25% to 30%, and ACR90 rates of 10% to 17%. Patients in the higher INCB01824 dose groups also demonstrated improvements on the HAQ-DI. INCB018424 was well tolerated; mild adverse events were reported but there were no serious infections in any treatment or placebo cohort. One INCB018424 patient experienced neutropenia that continued throughout the treatment period, but was resolved after the last active dose was given.18 RA Education Resources There are many resources for patients and health care professionals on RA. The goal of these materials is to educate, empower, and provide basic protocols related to administration procedures of the many biotherapeutic agents available to treat this disease. As noted earlier in this publication, significant advances have been made in the last decade in the treatment and management of people with rheumatic diseases of all types, and particularly of RA. Because early and aggressive treatment of rheumatic diseases is important in improving long-term outcomes, there is a need for targeted patient education on many aspects, such as: • therapy compliance; • drug interactions; • recognition of symptoms needing medical intervention; Kinase Inhibitors Kinases are a group of intercellular molecules responsible for the transfer of phosphate from high-energy donor mole- COUNSELING POINTS™ 8

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Counseling Points - December 2008

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