Pharmacy & Therapeutics - January 2009 - (Page 37) MEETING HIGHLIGHTS: American College of Rheumatology Table 3 Responses to Tocilizumab at 24 Weeks In Patients with Rheumatoid Arthritis ACR20 (%) 8 mg 4 mg Placebo P value 50.0 30.4 10.1 P < 0.0001 (for both) ACR50 (%) 28.8 16.8 6.0 P < 0.0001/ P = 0.0005 ACR70 (%) 12.4* 5.0 1.3 *P = 0.0014 weeks. The researchers used a Markov model to estimate the oneyear transition probability from employable to unemployable or from unemployable to employable, calculating employable life-years from age 45 to 55 years. For patients 45 years of age in ASPIRE, 31.4 % of women and 29.7% of men were unemployable according to a regression model at baseline. For patients beginning at age 45 and employable at baseline, the probability of continuing to be employable after one year of treatment was 0.928 in men and 0.905 in women in the infliximab group, and 0.899 in men and 0.867 in women receiving MTX, respectively. For patients who were unemployable at baseline, the probability of being employable after one year of treatment was 0.481 for men and 0.405 for women in the infliximab groups and 0.390 in men and 0.319 in women in the MTX groups, respectively. With the Markov model, it was predicted that after 10 years at age 55, 18.5% of women and 14.1% of men in the infliximab groups and 30.7% of women and 24.2% of men in the MTX groups would be unemployable. The model also predicted that 0.99 employable life-years would be expected to be retained per patient over 10 years in the infliximab patients compared with the MTX patients. The analysis, Dr. Chan concluded, demonstrated that patients treated with infliximab could gain economic benefit by retaining employability over time. • Jon Giles, MD, Assistant Professor of Medicine, Johns Hopkins University, Division of Rheumatology, Baltimore, Md. Dr. Giles commented in an interview: I think the bottom line is that patients who are very disabled and have a lot of active swelling and joint inflammation with the potential to have fairly rapid destruction of their joints are the ones you want to be very aggressive with and use the combination. If you can keep them working, then some of the enormous societal expenditures for RA can be averted. Patients receiving the 8-mg/kg dose were nine times more likely than controls to achieve a 20% improvement in signs and symptoms of disease according to ACR criteria (ACR20) at week 24, and patients receiving 4 mg/kg were four times more likely than controls to achieve ACR20 (P < 0.0001)(Table 3). The investigators reported a clear separation between tocilizumab 8 mg/kg and placebo in ACR20 response rates by week 4 as well as between ACR50 and ACR70 responses by week eight. Remission rates, defined by the Disease Activity Score using 28 joint counts (DAS 28), increased continually through the study among patients receiving tocilizumab 8 mg/kg. The DAS 28 remission rate reached 30% at week 24. Common adverse events included diarrhea, upper abdominal pain, rash, and dizziness. Serious adverse events were reported at rates of 6.3%, 7.4%, and 11.3% of the three groups, respectively. Serious infections rates were 4.6%, 1.8%, and 3.1% in the three groups, respectively. The overall response rates were 84% with 8 mg/kg and 87.1% with 4 mg/kg. Discontinuations were attributed to adverse events in approximately 6% of patients in the tocilizumab groups and in 5% of the placebo plus MTX group. Dr. Emery concluded that treatment with the combination of tocilizumab and MTX was associated with rapid and significant clinical improvement in this population with inadequate response to previous anti-TNF therapy. Examining the effect of prior anti-TNF therapy on outcomes, he said: “Tocilizumab is efficacious irrespective of the number of prior anti-TNFs, although the level of efficacy tends to be lower after failure with three prior anti-TNFs.” ASPIRE: Infliximab (Remicade) plus Methotrexate For Rheumatoid Arthritis • Chenglong Han, MD, Johnson & Johnson, Malvern, Pa. Treating early RA with infliximab plus MTX, compared with MTX alone, increases a patient’s chances of becoming or staying employed, according to an analysis of ASPIRE (Active Controlled Study of Patients Receiving Infliximab for Treatment of RA of Early Onset). Dr. Han noted that with RA occurring most frequently at the productive ages of 40 to 50 years, loss of employment is a major economic consequence. “Treatments that prevent disease progression may delay the time to loss of employability due to disability,” he said. ASPIRE compared the efficacy and safety of the two strategies in infliximab and MTX-naive patients with disease history of less than three years. Clinical efficacy and employment data were collected from the baseline appointment through 54 As for avoiding the much higher cost of infliximab, compared with that of generic MTX, he said: “In those with milder disease, you may not need a biologic combination. You still have a good chance of getting them under control with MTX by itself.” I Vol. 34 No. 1 • January 2009 • P&T® 37
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