Another Biologic Proves Superior to Methotrexate

Jeffrey P. Callen, MD

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In This Article

Abstract and Introduction

Abstract

Briakinumab produced better scores on the psoriasis area-and-severity index and the physician's global assessment tool.

Introduction

Biologic therapies have demonstrated efficacy for controlling psoriatic disease, but some have been withdrawn and others never make it to market because of safety issues. Briakinumab is a monoclonal antibody against the p40 molecule shared by interleukin-12 and interleukin-23. In a double-blinded trial, investigators randomized 317 patients with moderate-to-severe psoriasis to briakinumab (weeks 1 and 4, 200 mg; 100 mg every 4 weeks thereafter) or to methotrexate (5 mg/week initially, up to 25 mg/week); participants also received folic acid, 5 mg/week. Primary endpoints were improvement of at least 75% in the psoriasis area-and-severity index (PASI) score and scores indicating no or minimal disease on the physician's global assessment (PGA) at weeks 24 and 52.

At 24 weeks, 81.8% of briakinumab recipients, versus 39.9% of methotrexate recipients, had at least 75% PASI improvement. On the PGA, 80.5% of briakinumab recipients had no/minimal disease, versus 34.4% of methotrexate recipients. At 52 weeks, 66.2% versus 23.9% had at least a 75% PASI improvement and 63.0% versus 20.2% had no/minimal disease (P<0.001 for all comparisons).

The percentage with 75% PASI improvement declined in the methotrexate group between weeks 24 and 52, which I would not have predicted from my clinical experience. Serious infections and cancers were more frequent in briakinumab recipients, but not significantly so. No major cardiovascular adverse events occurred in either group. The authors note as a limitation that other psoriasis manifestations, specifically psoriatic arthritis, were not evaluated.

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