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Πέμπτη 16 Μαρτίου 2017

A Topical Treatment Optimisation Programme (TTOP) improves clinical outcome to calcipotriol/betamethasone gel in psoriasis: Results of the 64-week, multinational, randomized, phase IV study in 1790 patients (PSO-TOP)

Abstract

Background

Around two-thirds of psoriasis patients do not adhere to topical treatment. The 'Topical Treatment Optimisation Programme' (TTOP), a five-element tool, includes guidance for the conversation between dermatologists/nurses and patients, patient information material, telephone/email helpdesks and treatment reminders. It has been developed by patients and dermatologists to help increase adherence in psoriasis.

Objective

To compare TTOP with standard of care ('non-TTOP') within a large European investigator-initiated study, PSO-TOP (Clinicaltrials. gov NCT01587755).

Methods

Patients with mild to moderate psoriasis received calcipotriol/betamethasone dipropionate gel as standardized study medication and were randomized 1:1 to either TTOP or non-TTOP management. Study medication was applied once-daily for 8 weeks followed by 'as-needed' application for additional 56 weeks. A physicians' global assessment (PGA) of 'clear' or 'almost clear' was defined as response.

Results

In 1790 patients (full-analysis set), response rates after 8 weeks (primary objective) were significantly higher for TTOP (36.3%) than for non-TTOP (31.3%; P=0.0267). Better clinical outcome was accompanied by higher rates of patients feeling well informed about their skin condition and treatment and other factors related to adherence, but the dermatology life quality index (DLQI) was not statistically different. TTOP patients regarded the structured one-to-one conversations with their dermatologist/nurse as the most important element of TTOP.

Conclusions

Patients randomized to the TTOP intervention had a better clinical response than patients receiving standard of care. Improved communication between the healthcare provider and patient might be an important element in increasing adherence to topical therapy in psoriasis.

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