Psoriasis Drug May Also Clear Up Depression and Fatigue

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Psoriasis Drug May Also Clear Up Depression and Fatigue

By Jeff Minerd , MedPage Today Staff Writer

Reviewed by Jasmer, MD; Assistant Professor of Medicine,

University of California, San Francisco

Review

HOUSTON, Dec. 15 - At the same time that Enbrel (etanercept), a tumor

necrosis factor-alpha (TNF-a) inhibitor, relieves the clinical

symptoms of psoriasis, it may also clear up the depression and

fatigue common among those with this disease, researchers here reported.

In a double-blind placebo-controlled phase III trial, 55% of patients

taking Enbrel had significant reductions from baseline in symptoms of

depression after 12 weeks of therapy, found Tyring, M.D., of

the University of Texas Health Science Center here, and colleagues.

This compared with 39% of patients taking a placebo, they reported in

a study published online today by The Lancet.

Enbrel is approved by the FDA for treating symptoms of psoriasis as

well as psoriatic arthritis, rheumatoid arthritis, and ankylosing

spondylitis. Depression and fatigue are common among psoriasis

patients, the researchers noted, and are probably due in part to the

altered appearance of the skin and by joint pain in those who also

have psoriatic arthritis.

However, increased concentrations of pro-inflammatory cytokines such

as TNF-a have been associated with depression apart from psoriasis.

In addition, TNF-a has also been linked to fatigue and sleepiness.

Because psoriasis is a TNF-a -mediated disease, and because Enbrel

inhibits this cytokine, Dr. Tyring and colleagues sought to determine

whether the drug could affect depression and fatigue in these patients.

The double-blind study randomized 618 patients with mild-to- severe

psoriasis, half to placebo and half to 50 mg of Enbrel twice weekly

for 12 weeks. The primary efficacy endpoint was a 75% or greater

improvement from baseline in severity of psoriasis symptoms.

Secondary outcomes included significant reduction in symptoms of

depression and fatigue from baseline as measured by the Beck

depression inventory (BDI), the Hamilton rating scale for depression

(Ham-D), and the functional assessment of chronic illness therapy

fatigue (FACIT-F) scale.

At baseline, 26% of the placebo arm and 25% of the treatment group

had mild or moderate-to-severe depression as rated by the Ham-D. In

addition, 35% of the placebo group and 34% of the treatment group had

mild or moderate-to-severe depression as measured by the BDI.

Key findings at week 12 included:

47% of patients in the treatment group achieved a 75% or greater

improvement in psoriasis symptoms, compared with 5% of the placebo

group (P<0.0001).

55% of patients taking Enbrel had significant reductions from

baseline in symptoms of depression as measured by the BDI, compared

with 39% of a placebo group (P=0.0001).

43% of patients in the treatment group showed improved symptoms of

depression as measured by Ham-D, versus 32% of the placebo group

(P=0.0048).

The treatment group improved an average of five points on the FACIT-F

scale. An improvement of three points on this 52-point fatigue scale

is considered clinically significant. The placebo group improved an

average of 1.9 points. (P<0.0001).

The researchers argued that the improvements in depression were not

caused merely by the reduction of disease symptoms. They noted, for

example, that improvements on the Ham-D were not well correlated with

improvements of psoriasis symptoms, and that the correlation was not

significant (P=0.0848).

However, they acknowledged that their study was not designed to

detect a treatment effect on primary depression. " To study any such

effect, it would be necessary to examine patients who did not have

psoriasis but had been diagnosed with depression, " they said.

Still, " etanercept treatment might relieve fatigue and symptoms of

depression associated with this chronic disease, " they concluded.

A main weakness of the study was the small numbers of patients with

moderate-to-severe depression, said Jan D. Bos, M.D., and de

Korte, M.D., of the University of Amsterdam, in an accompanying

editorial.

Only 15% of patients in the treatment group had moderate-to-severe

depression as rated by the BDI and only 2% as measured by the Ham-D,

the commentators noted. Proportions in the placebo group were similar.

" In future studies, it would be interesting to measure the effects of

anti-TNF-a agents in patients with psoriasis with high levels of

depression and fatigue, " they said.

The study was funded by Immunex, which markets Enbrel.

Primary source: The Lancet

Source reference:

Tyring S et al. Etanercept and clinical outcomes, fatigue, and

depression in psoriasis: double-blind, placebo-controlled randomized

trial. The Lancet. Advanced online publication December 15, 2005.

Additional source: The Lancet

Source reference:

Bos JD and de Korte J. Effects of etanercept on quality of life,

fatigue, and depression is psoriasis. The Lancet. Advanced online

publication December 15, 2005.

http://www.medpagetoday.com/Dermatology/Psoriasis/tb/2335