Clinical questions The only questions raised by the evaluator concerned the Product Information document and discussion of these are beyond the scope of this AusPAR. Second evaluation of clinical data submitted in response to questions Second round benefit-risk assessment Second round assessment of benefits After consideration of the responses to clinical questions, the benefits of adalimumab in the proposed usage were considered to be unchanged from those identified in the First Round Evaluation. Second round assessment of risks After consideration of the responses to clinical questions, the risks of adalimumab in the proposed usage were considered to be unchanged from those identified in the First Round Evaluation. Second round assessment of benefit-risk balance The benefit-risk balance of adalimumab, given the proposed usage, was considered to be favourable. Second round recommendation regarding authorisation The evaluator recommended that adalimumab should be approved for the additional indication of: Non-Radiographic Axial Spondyloarthritis Humira is indicated for reducing signs and symptoms in patients with non-radiographic axial spondyloarthritis. References Appel H. et al. Serum levels of biomarkers of bone and cartilage destruction and new bone formation in different cohorts of patients with axial spondyloarthritis with and without tumor necrosis factor-alpha blocker treatment. Available online <> Barkham N et al. Clinical and Imaging Efficacy of Infliximab in HLA–B27–Positive Patients With Magnetic Resonance Imaging–Determined Early Sacroiliitis. Arthritis & Rheumatism Vol. 60, No. 4, April 2009, pp 946–954 Braun J et al. Efficacy of sulfasalazine in patients with inflammatory back pain due to undifferentiated spondyloarthritis and early ankylosing spondylitis: a multicentre randomised controlled trial. Ann Rheum Dis 2006;65:1147–1153. Braun J et al. 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis 2011;70:896–904 Chen J and Liu C. Methotrexate for ankylosing spondylitis (Protocol).
Clinical questions The only questions raised by the evaluator concerned the Product Information document and discussion of these are beyond the scope of this AusPAR. Second evaluation of clinical data submitted in response to questions Second round benefit-risk assessment Second round assessment of benefits After consideration of the responses to clinical questions, the benefits of adalimumab in the proposed usage were considered to be unchanged from those identified in the First Round Evaluation. Second round assessment of risks After consideration of the responses to clinical questions, the risks of adalimumab in the proposed usage were considered to be unchanged from those identified in the First Round Evaluation. Second round assessment of benefit-risk balance The benefit-risk balance of adalimumab, given the proposed usage, was considered to be favourable. Second round recommendation regarding authorisation The evaluator recommended that adalimumab should be approved for the additional indication of: Non-Radiographic Axial Spondyloarthritis Humira is indicated for reducing signs and symptoms in patients with non-radiographic axial spondyloarthritis. References Appel H. et al. Serum levels of biomarkers of bone and cartilage destruction and new bone formation in different cohorts of patients with axial spondyloarthritis with and without tumor necrosis factor-alpha blocker treatment. Available online <> Barkham N et al. Clinical and Imaging Efficacy of Infliximab in HLA–B27–Positive Patients With Magnetic Resonance Imaging–Determined Early Sacroiliitis. Arthritis & Rheumatism Vol. 60, No. 4, April 2009, pp 946–954 Braun J et al. Efficacy of sulfasalazine in patients with inflammatory back pain due to undifferentiated spondyloarthritis and early ankylosing spondylitis: a multicentre randomised controlled trial. Ann Rheum Dis 2006;65:1147–1153. Braun J et al. 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis 2011;70:896–904 Chen J and Liu C. Methotrexate for ankylosing spondylitis (Protocol).
auspar-adalimumab-140122-cer.docx