HUMIRA

Substantial actual benefit in the extension of the indication

The extension of the indication of HUMIRA in the treatment of adults with severe axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs does not change the substantial improvement in actual benefit (IAB II) attributed to HUMIRA for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy, while waiting for the results of the 144-week open-label follow-up phase of the ABILITY-1 study.