Pharmacy & Therapeutics - January 2009 - (Page 36) MEETING HIGHLIGHTS: American College of Rheumatology American College of Rheumatology Scientific Meeting The American College of Rheumatology’s annual meeting, the premier scientific meeting devoted to rheumatic disease, took place in San Francisco from October 24 to 29, 2008. Highlights among the many sessions included three sessions on anti-TNF monoclonal antibodies. All subjects still receiving placebo at week 20 were switched to golimumab 50 mg from weeks 24 through 52 (Table 2). In patients with more than 3% of their BSA affected by psoriatic skin involvement at baseline, 55.9% of those in the 50-mg group and 66% of those in the 100-mg group achieved at least 75% PASI improvement (PASI 75) at 24 weeks, compared with 1.4% of those receiving placebo (P < 0.001). At 52 weeks, the rates were 62% and 69.3% of treated patients, respectively. Of the golimumab patients, 2.4% reported serious adverse events through week 24, compared with 6.2% of the placebo patients. Up to week 52, golimumab was generally well tolerated, with a safety profile similar to that observed in the first 24 weeks of treatment. Dr. Kavanaugh concluded, “The sustained effects of golimumab here are encouraging for physicians and for the many patients living with this potentially debilitating disease.” GO-REVEAL: Golimumab (CNTO 148) For Psoriatic Arthritis • Arthur Kavanaugh, MD, Professor of Medicine, University of California, San Diego One-year data show sustained improvements in signs and symptoms of active psoriatic arthritis with subcutaneous (SQ) injections every four weeks of either 50 mg or 100 mg of golimumab (Centocor/Schering-Plough). The finding, according to GO-REVEAL (Golimumab, A Randomized Evaluation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody), said Dr. Kavanaugh, the lead investigator, “demonstrate the long-term efficacy of this golimumab dosing in improving physical symptoms, functional ability, and quality of life.” Golimumab, a human anti-tumor necrosis factor–alpha (TNF-α) monoclonal antibody, is being evaluated also in phase 3 trials for treating rheumatoid arthritis and ankylosing spondylitis. It targets and neutralizes both the soluble and membranebound forms of TNF-α. The original 24-week phase of GO-REVEAL enrolled 405 patients who had at least three swollen and at least three tender joints. They received the same golimumab SQ dose of 50 or 100 mg every four weeks and were evaluated according to three endpoints, defined by the American College of Radiology criteria in the percentage of improvement in signs and symptoms (ACR20, ACR50, and ACR70). Patients with more than 3% body surface area (BSA) skin involvement at baseline were evaluated for Psoriatic Area and Severity Index (PASI) responses. At week 24, 52.1% of patients receiving golimumab 50 mg and 61% of those receiving golimumab 100 mg had achieved ACR20, compared with 12% of those receiving placebo (P < 0.001) (Table 1). By week 52, among 237 evaluable subjects, 78.4% of patients in the 50-mg group and 74.1% of those in the 100-mg group achieved ACR20. Table 1 Responses to Golimumab at 24 Weeks In Patients with Psoriatic Arthritis ACR20 (%) 50 mg 100 mg Placebo P value 51.2 61.0 12 <0.001 ACR50 (%) 32.2 37.7 3.5 <0.001 ACR70 (%) 18.5 21.2 0.9 <0.001 RADIATE: Tocilizumab for Rheumatic Arthritis • Paul Emery, MD, University of Leeds, Leeds, U.K. For rheumatoid arthritis (RA) that has been refractory to one or more anti-TNF agents, tocilizumab plus methotrexate (MTX) provides rapid and significant improvement in signs and symptoms. The improvements, stated Dr. Emery, are experienced irrespective of multiple, previous anti-TNF treatments. Interleukin 6 (IL-6) is a key pleiotropic pro-inflammatory cytokine that plays a pivotal role in the pathogenesis of RA. Tocilizumab is a humanized anti–IL-6 receptor monoclonal antibody that inhibits pro-inflammatory effects of IL-6. It has been efficacious in patients whose response to MTX or diseasemodifying anti-rheumatic drugs (DMARDs) is inadequate. Patients in RADIATE (Research on Actemra Determining efficacy after Anti-TNF failurEs), said Dr. Emery, had moderate-to-severe RA for at least six months and had responded inadequately to etanercept (Enbrel, Amgen, Wyeth), adalimumab (Humira, Abbott) or infliximab (Remicade, Centocor). Patients were predominantly female (82%) (mean age, 53 years). They were randomly assigned to receive placebo plus MTX (n = 160), tocilizumab 4 mg/kg plus MTX (n = 163), or tocilizumab 8 mg/kg plus MTX (n = 175). The primary endpoint was the proportion of patients achieving ACR20. Secondary endpoints included ACR50 and ACR70 responses. About 50% of the patients had received one prior anti-TNF agent and approximately 15% had tried three. Analysis revealed that all outcomes with 8 mg/kg and most outcomes with 3 mg/kg were significantly better than those in the control group. Withdrawal from treatment or the need for rescue therapy occurred in 25% and 34% of the tocilizumab groups, respectively, and in 60% of controls. Table 2 Responses to Golimumab at 52 Weeks In Patients with Psoriatic Arthritis ACR20 (%) 50 mg 100 mg 78.4 74.1 ACR50 (%) 56.9 52.6 ACR70 (%) 43.1 31.1 36 P&T® • January 2009 • Vol. 34 No. 1
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