An FDA panel of advisers rejected the bid to gain approval of AbbVies’s Humira (adalimumab) for treatment of active nonradiographic axial spondyloarthritis in adults with signs of inflammation by elevated CRP or MRI.
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An FDA panel of advisers rejected the bid to gain approval of AbbVies’s Humira (adalimumab) for treatment of active nonradiographic axial spondyloarthritis in adults with signs of inflammation by elevated CRP or MRI. The panel rejected the bid by an overwhelming 12-1 vote with one abstention. The Arthritis Advisory Committee split 7-6 with one abstention when surveyed about recommending approval of UCB’s Cimzia (certolizumab) for treatment of active axial spondyloarthritis, including ankylosing spondylitis (AS). In both cases, the debate surrounded the uncertainty regarding the loose definition of nonradiographic ax-SpA (nr-axSpA) and whether each of the respective manufacturers had provided sufficient evidence to support licensure in that patient subgroup. Both biologic drugs are expensive and associated with adverse effects such as serious infections. Panelists noted that in this area of treatment, these drugs have the potential to be inappropriately prescribed for people who actually have mechanical, rather than inflammatory, back pain.
Axial SpA includes both patients with ankylosing spondylitis (AS) and those with nr-axSpA. The 2 conditions share similar clinical, imaging, and laboratory features, but patients with nr-axSpA do not have radiographic sacroiliitis and are considered to have an earlier form of AS, although not all will progress if left untreated.
Adalimumab is currently approved for treatment of rheumatoid arthritis, plaque psoriasis, ulcerative colitis, ankylosing spondylitis and psoriatic arthritis and is approved for nr-axSpA in 50 countries including the European Union, AbbVie Vice President John Medich, PhD, told the panel. Certolizumab is currently FDA-approved for treatment of Crohn’s disease and rheumatoid arthritis.
Members of the advisory committee were weary of the new indication for adalimumab as an FDA review found that the single trial supporting approval had enrolled a high proportion of patients with ankylosing spondylitis who performed better than patients with radiographic evidence of spondyloarthritis. This effect caused an increase the apparent treatment effect of adalimumab in the overall study population.
Acting committee chair Tuhina Neogi, MD, PhD, associate professor of medicine and epidemiology at Boston University Schools of Medicine and Public Health in Massachusetts, noted that there were a small number of patients with nr-axSpA exposed to adalimumab in addition to ambiguity of the subgroup definition. “I struggled with the question…. I do acknowledge overall the study was positive, and I think there is a treatment effect there. I just am not comfortable yet that this trial has helped us identify that particular subgroup.”
In the case of certolizumab, panel members also expressed mixed feelings about the nr-axSpA definition, with several suggesting they would be more comfortable with more data and a more restrictive definition for the subgroup. Several committee members suggested the FDA could work with the manufacturer, Belgium drugmaker UCB, to create a better definition and label so providers know who is best to receive the drug.
There is currently no drug licensed for the treatment of nonradiographic axial spondyloarthritis. The FDA isn’t obligated to follow the advice of its advisory committees but usually does.
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