Source: DGNews  |

Addition of Methotrexate to Etanercept Significantly Improves Treatment Response in Patients With Moderate to Severe Psoriasis
: Presented at EADV

By Jenny Powers

LISBON, Portugal -- October 25, 2011 -- More patients with moderate to severe
psoriasis had faster improvement of their psoriasis, as measured by a 75%
reduction in Psoriasis Area and Severity (PASI 75) scores at 12 weeks after
combination treatment with methotrexate and etanercept than with etanercept
monotherapy, according to a study presented here at the 20th Congress of the
European Academy of Dermatology and Venereology (EADV).

Alice B. Gottlieb, MD, PhD, Tufts Medical Center, Boston, Massachusetts,
presented the findings on October 22. She and an international research team
conducted a phase 3 trial to evaluate whether adding methotrexate to etanercept
would increase response over etanercept alone in patients with moderate to
severe psoriasis.

Etanercept is a tumour necrosis factor inhibitor that has shown efficacy for
the treatment of psoriasis. Seeking to further improve response, the
researchers tested the addition of methotrexate, an agent that interferes with
DNA and RNA synthesis and the production of proteins, thus stopping the rapid
cell turnover indicative of psoriasis.

In this trial, all patients received etanercept for 12 weeks and were then
randomised into 2 groups of 239 patients each who were treated for an
additional 12 weeks with etanercept plus either methotrexate or placebo.

After 12 weeks of treatment, 70.2% of patients receiving etanercept plus
methotrexate versus 54.3% of etanercept-only patients achieved PASI 75
(P =.0112), and 34.0% versus 23.1% achieved PASI-90 (P
=.0348).

After 24 weeks, 77.3% of patients treated with etanercept plus methotrexate
achieved PASI 75 versus 60.3% of patients receiving etanercept monotherapy
(P <.0001). At the same time point, PASI 90 was achieved by 53.8% of
combination-therapy patients versus 34.2% of patients on monotherapy
(P =.0112).

Static Physician Global Assessment of clear or almost clear was observed in
71.8% versus 54.3% of patients receiving etanercept plus methotrexate versus
etanercept alone, respectively (P =.0112).

More adverse events were reported by patients in the etanercept plus
methotrexate arm; 74.9% of combination-therapy patients reported adverse events
versus 59.8% of patients receiving etanercept alone. Six serious adverse
events, 3 per treatment arm, were reported in 5 patients. Combination therapy
was well tolerated.

“Addition of methotrexate to etanercept increased efficacy over the good
response already observed with etanercept monotherapy in adults with moderate
to severe plaque psoriasis,” said Dr. Gottlieb.

Funding for this study was provided by Abbott.

[Presentation title: Efficacy and Safety of Adding Methotrexate
to Etanercept Versus Etanercept Monotherapy in Adults With Moderate to Severe Plaque Psoriasis. Abstract PO1085]