Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: 3-year results from two randomized phase III trials (CIMPASI-1 and CIMPASI-2).

BACKGROUND: Certolizumab pegol (CZP) is an Fc-free, PEGylated anti-tumour necrosis factor biologic. OBJECTIVES: To report the 3-year efficacy of CZP in plaque psoriasis, pooled from the CIMPASI-1 (NCT02326298) and CIMPASI-2 (NCT02326272) phase III trials. METHODS: Adults with moderate-to-severe psoriasis for ≥ 6 months were randomized 2 : 2 : 1 to CZP 200 mg, CZP 400 mg or placebo, every 2 weeks (Q2W) for up to 48 weeks. Patients entering the open-label period (weeks 48-144) from double-blinded CZP initially received CZP 200 mg Q2W. Patients not achieving ≥ 50% improvement in Psoriasis Area and Severity Index (PASI 50) at week 16 entered an open-label CZP 400 mg Q2W escape arm (weeks 16-144). Dose adjustments based on PASI response were permitted during open-label treatment. Outcomes included PASI 75, PASI 90 and Physician's Global Assessment (PGA) 0/1 responder rates, based on a logistic regression model (missing data imputed using Markov Chain Monte Carlo methodology). RESULTS: In total, 186 patients were randomized to CZP 200 mg Q2W and 175 to CZP 400 mg Q2W. At week 48, PASI 75/90 was achieved by 72·7%/51·3% of patients randomized to CZP 200 mg and 84·4%/62·7% randomized to CZP 400 mg. Patients entering the open-label period at week 48, from blinded treatment, received CZP 200 mg Q2W. At week 144, PASI 75/90 was achieved by 70·6%/48·7% patients randomized to CZP 200 mg and 72·9%/42·7% randomized to CZP 400 mg. At week 16, 72 placebo-randomized patients entered the CZP 400 mg Q2W escape arm; 75.7%/58.5% achieved PASI 75/90 at week 144. CONCLUSIONS: Both CZP 200 mg and 400 mg Q2W demonstrated sustained, durable efficacy, with numerically higher responses for some outcomes with 400 mg Q2W.

Integration of micrometer-sized polymer elements at the end of optical fibers by free-radical photopolymerization.

A simple method of manufacturing micrometer-sized polymer elements at the extremity of both single-mode and multimode optical fibers is reported. The procedure consists of depositing a drop of a liquid photopolymerizable formulation on a cleaved fiber and using the light that emerges from the fiber to induce the polymerization process. After exposure and rinsing a polymer tip is firmly attached to the fiber as an extension of the fiber core. It is shown that the tip geometry can be adjusted by the variation of basic parameters such as the geometry of the deposited drop and the conditions of drop illumination. When this process is applied to a multimode fiber three-dimensional molds of the fiber's linearly polarized modes can be obtained. The process of polymer-tip formation was simulated by a numerical calculation that consisted of an iterative beam-propagation method in a medium whose refractive index is time varying. It is shown that this process is based on the gradual growth, just above the fiber core, of an optical waveguide in the liquid formulation. Experimental data concerning two potential uses of the tipped fibers are presented.