Efficacy of ixekizumab compared to etanercept and placebo in patients with moderate-to-severe plaque psoriasis and non-pustular palmoplantar involvement: results from three phase 3 trials (UNCOVER-1, UNCOVER-2 and UNCOVER-3).

BACKGROUND: Palmoplantar psoriasis has significant physical and emotional impact on patients and can be difficult to treat. OBJECTIVE: To evaluate the efficacy of ixekizumab in the treatment of patients with moderate-to-severe plaque psoriasis and moderate-to-severe non-pustular palmoplantar involvement. METHODS: In three phase 3, double-blind, placebo-controlled trials, patients with moderate-to-severe non-pustular plaque psoriasis [UNCOVER-1 (N = 1296), UNCOVER-2 (N = 1224), UNCOVER-3 (N = 1346)] were randomized to subcutaneous 80 mg ixekizumab every 2 or 4 weeks (Q2W, Q4W), after a 160-mg starting dose, or placebo through week 12. Additional UNCOVER-2 and UNCOVER-3 cohorts were randomized to 50 mg etanercept biweekly. Patients entering the open-label long-term extension (UNCOVER-3) received ixekizumab Q4W weeks 12-60. Moderate-to-severe palmoplantar involvement was defined as Palmoplantar Psoriasis Area and Severity Index (PPASI) ≥8. RESULTS: Twenty-eight percent of UNCOVER-1, UNCOVER-2 and UNCOVER-3 patients had baseline palmoplantar involvement (PPASI ≥0, n = 1092) and 9.1% (n = 350) had moderate-to-severe involvement, with mean baseline PPASI ~20, PASI ~24, and most (>60%) had static Physician's Global Assessment ≥4. Higher percentages of patients treated with ixekizumab vs. placebo or etanercept achieved PPASI 50 (approximately 80% vs. 32.9%, 67.8%; ixekizumab, placebo, etanercept, respectively) and PPASI 75 (approximately 70% vs. 18.8%, 44.1%; ixekizumab, placebo, etanercept, respectively) at week 12 (all P < 0.05). PPASI 100 was achieved by higher percentages of ixekizumab-treated patients vs. placebo (approximately 50% vs. 8.2%, P < 0.001) and ixekizumab Q2W-treated patients vs. etanercept (51.8% vs. 32.2%, P < 0.05). Outcomes were maintained or improved in patients continuing on ixekizumab Q4W through week 60. Differences between ixekizumab and placebo or etanercept were statistically significant as early as week 1. CONCLUSION: In a subpopulation analysis of patients from phase 3 trials with moderate-to-severe non-pustular palmoplantar involvement and moderate-to-severe plaque psoriasis, ixekizumab treatment resulted in greater and more rapid improvements than placebo and etanercept at week 12; improvements were sustained with continued treatment.

Measurement of radiated electromagnetic field levels before and after a changeover to energy-efficient lighting.

An energy-efficient lighting retrofit at the Food and Drug Administration (FDA) Winchester Engineering and Analytical Center (WEAC) presented the opportunity to measure the electromagnetic (EM) environments in several rooms before and after changing the fluorescent lighting systems and to compare the changes in EM fields with the proposed standard EM immunity levels. Three rooms, representing the types of work areas in the laboratory, were selected and measured before and after the lighting changeover. Electric and magnetic field measurements were taken in the extremely low frequency (ELF), very low frequency (VLF), and radio frequency (RF) ranges of the EM spectrum. In 2 rooms, ELF electric fields were reduced and VLF and RF electric fields were increased as a result of the changeover to high-frequency fixtures. A third room received low-frequency, energy-efficient fixtures during this changeover, and this change resulted in only a slight increase of the ELF electric fields. The ELF magnetic fields were greatly reduced in 2 but only slightly reduced in the third room. No significant change was seen in VLF or RF magnetic fields for any of these rooms. Some field-strength measurements exceeded the proposed immunity levels recommended in the draft International Electrotechnical Commission standard IEC 60601-1-2 (rev. 2). The data show that increasing the separation distance from the fluorescent light fixtures greatly reduces the field-strength levels, limiting the potential for EM interference.