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Secukinumab Clears Skin of Psoriasis Patients in Phase III Trials

New analysis shows consistent efficacy

New phase III trial data have shown that treatment with 300 mg of secukinumab (AIN457, Novartis) resulted in higher rates of clear to almost-clear skin at week 12 compared with placebo, regardless of the patients’ psoriasis severity.

The data were presented at the European Association of Dermatology and Venereology Congress in Amsterdam.

Novartis expects global regulatory approvals for secukinumab “shortly.”

In the studies, the majority of patients across two disease-severity subgroups, including those with severe psoriasis, experienced completely clear to almost-clear skin, measured as a 100% or 90% reduction of respective baseline Psoriasis Area and Severity Index (PASI) (P < 0.0001). Skin clearance was sustained through 1 year of treatment (P < 0.0001). Historically, psoriasis patients’ disease severity at the start of treatment has limited their response to other therapies.

Disease severity subgroups in the studies had a PASI score of less than or equal to 20 or a PASI score of greater than 20. The PASI measures the redness, scaling, and thickness of psoriatic plaques and their effects in regions of the body. The new findings confirm the significantly better responses seen in the FIXTURE study, in which secukinumab showed superiority over etanercept (Enbrel, Amgen), a standard-of-care anti-tumor necrosis factor (TNF) medication.

In addition to the disease-severity data, another secukinumab analysis showed that significantly more patients receiving active treatment experienced clear or almost-clear skin with no impairment in quality of life, as measured by PASI 100/PASI 90 and the Dermatology Quality of Life Index, compared with those with PASI scores of less than 90 (P < 0.001). More than 70% of patients treated with secukinumab 300 mg experienced clear or almost-clear skin during the first 16 weeks of treatment.

The effect of psoriasis on patients' quality of life is similar to that of cancer, heart disease, arthritis, type-2 diabetes, and depression. The painful symptoms limit the ability of patients to undertake daily activities and affect their social relationships.

The analyses pooled data from four pivotal phase III studies of secukinumab in moderate-to-severe plaque psoriasis: ERASURE, FIXTURE, FEATURE, and JUNCTURE. The trials were part of a phase III program that involved more than 3,300 patients in more than 35 countries. All of the studies assessed the efficacy, safety, and tolerability of secukinumab 300 mg or 150 mg in the induction period (at week 12) and during maintenance therapy (at week 52).

Secukinumab is a fully human monoclonal antibody being investigated for diseases that affect the immune system. It stops the protein interleukin-17A (IL-17A) from its involvement in the development of psoriasis. IL-17A is found in high concentrations in skin affected by the disease.

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