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Two phase 3 clinical trials found that the monoclonal antibody secukinumab was more effective at treating moderate to severe plaque psoriasis than placebo or etanercept. Secukinumab works by inhibiting interleukin-17A. The trials showed secukinumab provided faster response rates and maintained efficacy over time compared to the other treatments. However, infectious complications occurred more often in patients receiving secukinumab than placebo. The studies validated interleukin-17A as an effective therapeutic target for psoriasis treatment.
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- 1. Original Article Secukinumab in Plaque Psoriasis — Results of Two Phase 3 Trials Richard G. Langley, M.D., Boni E. Elewski, M.D., Mark Lebwohl, M.D., Kristian Reich, M.D., Ph.D., Christopher E.M. Griffiths, M.D., Kim Papp, M.D., Ph.D., Lluís Puig, M.D., Ph.D., Hidemi Nakagawa, M.D., Ph.D., Lynda Spelman, M.B., B.S., Bárður Sigurgeirsson, M.D., Ph.D., Enrique Rivas, M.D., Tsen-Fang Tsai, M.D., Norman Wasel, M.D., Stephen Tyring, M.D., Ph.D., Thomas Salko, B.A., Isabelle Hampele, Ph.D., Marianne Notter, M.S., Alexander Karpov, Ph.D., Silvia Helou, M.D., Ph.D., Charis Papavassilis, M.D., Ph.D., for the ERASURE and FIXTURE Study Groups N Engl J Med Volume 371(4):326-338 July 24, 2014
- 2. Study Overview • In two trials in patients with moderate-to-severe plaque psoriasis, the anti–interleukin-17A monoclonal antibody secukinumab was more effective than placebo and etanercept. • Infectious complications occurred more often with secukinumab than with placebo.
- 3. Speed of Response. Langley RG et al. N Engl J Med 2014;371:326-338
- 4. Efficacy over Time. Langley RG et al. N Engl J Med 2014;371:326-338
- 5. Demographic and Baseline Clinical Characteristics of the Patients. Langley RG et al. N Engl J Med 2014;371:326-338
- 6. Efficacy End Points in ERASURE. Langley RG et al. N Engl J Med 2014;371:326-338
- 7. Efficacy End Points in FIXTURE. Langley RG et al. N Engl J Med 2014;371:326-338
- 8. Adverse Events during the Induction Period and the Entire 52-Week Study Period in FIXTURE. Langley RG et al. N Engl J Med 2014;371:326-338
- 9. Conclusions • Secukinumab was effective for psoriasis in two randomized trials, validating interleukin-17A as a therapeutic target.
Editor's Notes
- Figure 1 Speed of Response. The speed of response among patients in the Full Year Investigative Examination of Secukinumab versus Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis (FIXTURE) study was evaluated according to the median time to a 50% reduction from baseline in the mean score on the psoriasis area-and-severity index (PASI; scores range from 0 to 72, with higher scores indicating more severe disease). A repeated-measures, mixed-effects model was used to analyze the mean percentage change from baseline in the PASI score. Symbols without black outlining indicate the least-squares means, and I bars the 95% confidence intervals (CIs). The median time to a 50% reduction in the mean PASI score (dashed line) was estimated from parametric bootstrap samples with the use of linear interpolation between time points. A 50% reduction in the mean PASI score was not observed in the placebo group, so an analysis of the median time to 50% reduction was not conducted.
- Figure 2 Efficacy over Time. Panel A shows the results in the Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis (ERASURE) study, and Panel B the results in the FIXTURE study. Shown are the proportions of patients who met the criteria for prespecified efficacy end points at each visit to week 52. The PASI 75, PASI 90, and PASI 100 responses indicate reductions from baseline in the PASI score of 75% or more, 90% or more, and 100%, respectively. Missing values were imputed as nonresponses. Only patients who could be evaluated for a response were included. IGA denotes investigator's global assessment.
- Table 1 Demographic and Baseline Clinical Characteristics of the Patients.
- Table 2 Efficacy End Points in ERASURE.
- Table 3 Efficacy End Points in FIXTURE.
- Table 4 Adverse Events during the Induction Period and the Entire 52-Week Study Period in FIXTURE.