PAUSE Psoriasis Trial Completes Enrollment

The Immune Tolerance Network completed enrollment for the PAUSE psoriasis study with 108 participants. Led by Dr. James Krueger at the Rockefeller University, the PAUSE Study is testing the combination of two biologics, ustekinumab (Janssen Biotech, Inc.) and abatacept (Bristol-Myers Squibb), in psoriasis patients. The goal of the PAUSE study is to determine whether the sequential combination of ustekinumab and abatacept in psoriasis will produce changes in the immune system that will lead to durable disease remission.

Psoriasis is a chronic T-cell mediated autoimmune disorder that causes inflammation of the skin and joints, often marked by skin rashes and plaques. Ustekinumab, a biologic that blocks the inflammatory cytokines IL-12 and IL-23, is effective at inducing disease remission and is approved for use in psoriasis. Although ustekinumab works in a large portion of patients, the benefits require ongoing treatment. There are currently no known therapies for psoriasis that can induce long-lasting tolerance.

Abatacept is a biologic approved for use in rheumatoid arthritis that blocks a co-stimulatory signal necessary for T cell activation. ITN investigators hypothesize that tolerance may be achieved by first reducing inflammation using ustekinumab, followed by co-stimulatory blockade with abatacept to prevent subsequent re-activation of T cells. More about the PAUSE study can be seen here.

All 108 participants in PAUSE will enter an open label lead-in ustekinumab phase, after which 80 patients who respond to treatment will be randomized to receive either abatacept or continued ustekinumab. Both groups will discontinue therapy and participants will be followed for another year to compare durability of disease remission between the two treatment groups.

The PAUSE Study is being conducted at 10 clinical centers across the US and Canada (Kirk Barber Research, Dermatology Research Associates, Northwestern University, Tulane University, University of Michigan, The Rockefeller University, Wake Forest University, Case Western Reserve University, Innovaderm Research, and University of Utah). Results of the PAUSE Study are expected in early 2018.