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Table 2 Summary of licensed biologic agents indicated for the treatment of axSpA

From: Targeting inflammatory pathways in axial spondyloarthritis

Name Mechanism of action Indication Administration Pivotal study Primary endpoint(s) Safety considerations from prescribing information
Adalimumab [171] Human IgG1k. Binds soluble and transmembrane TNF. All TNF monoclonal antibodies can lyse surface TNF-expressing cells in vitro in the presence of complement US: AS
EU: AS and nr-axSpA
40 mg every other week
Half-life of ~ 14 days
ABILITY-1 [172] ASAS40 at week 12
• Adalimumab: 36% (P < 0.001)
• Placebo: 15%
• Serious infections
• Invasive fungal infections
• Malignancies
• Anaphylaxis or serious allergic reactions
• Hepatitis B virus reactivation
• Demyelinating disease
• Cytopenias, pancytopenia
• Heart failure
• Lupus-like syndrome
Certolizumab pegol [173] Fab fragment of humanized anti-TNF fused to polyethylene glycol. Binds to human TNF-α. Cannot bind to Fc receptors, fix complement, or cross placenta US: AS and nr-axSpA
EU: AS and nr-axSpA
400 mg SC at 1, 2, and 4 weeks, then 200 mg q2w or 400 mg q4w
Half-life of ~ 14 days
RAPID-axSpA [11] ASAS20 at week 12
• Certolizumab 200 mg Q2W: 58% (P = 0.004)
• Certolizumab 400 mg Q4W: 64% (P < 0.001)
• Placebo: 38%
• Serious infections
• Invasive fungal infections
• Malignancies
• Anaphylaxis or serious allergic reactions
• Hepatitis B virus reactivation
• Demyelinating disease
• Cytopenias, pancytopenia
• Heart failure
• Lupus-like syndrome
Etanercept [174] Fusion protein of extracellular-binding sites of 2 TNF p75 receptors linked to the Fc portion of human IgG1. Binds soluble TNF and lymphotoxin α (TNF-β) molecules US: AS
EU: AS and nr-axSpA
25 mg twice weekly
Half-life of ~ 4 days
Double-blind randomized controlled trial [38] ASAS20 at week 12
• Etanercept: 59% (P < 0.0001)
• Placebo: 28%
   ASAS20 at week 24
• Etanercept: 57% (P < 0.0001)
• Placebo: 22%
• Serious infections
• Invasive fungal infections
• Malignancies
• Anaphylaxis or serious allergic reactions
• Hepatitis B virus reactivation
• Demyelinating disease
• Cytopenias, pancytopenia
• Heart failure
• Lupus-like syndrome
Golimumab [175] Human IgG1κ monoclonal antibody. Binds soluble and transmembrane human TNF-α US: AS
EU: AS
50 or 100 mg SC once/month
Half-life of ~ 14 days
GO-RAISE [40] ASAS20 at week 14
• Golimumab 50 mg: 59% (P < 0.001)
• Golimumab 100 mg: 60% (P < 0.001)
• Placebo: 22%
• Serious infections
• Invasive fungal infections
• Malignancies
• Anaphylaxis or serious allergic reactions
• Hepatitis B virus reactivation
• Demyelinating disease
• Cytopenias, pancytopenia
• Heart failure
• Lupus-like syndrome
Infliximab [176] Chimeric mouse-human monoclonal antibody with human constant and murine variable regions. Binds with high affinity to soluble and transmembrane TNF-α US: AS
EU: AS
5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks
Half-life of ~ 9 days
ASSERT [39] ASAS20 at week 24
• Infliximab: 61% (P < 0.001)
• Placebo: 19%
• Serious infections
• Invasive fungal infections
• Malignancies
• Anaphylaxis or serious allergic reactions
• Hepatitis B virus reactivation
• Demyelinating disease
• Cytopenias, pancytopenia
• Heart failure
• Lupus-like syndrome
• Hepatotoxicity
• Cardiovascular and cerebrovascular reactions
Secukinumab [91] Human anti-IL-17A monoclonal antibody US: AS
EU: AS
MEASURE 1: 10 mg/kg IV at weeks 0, 2, and 4 followed by 75 mg or 150 mg SC Q4W from week 8
MEASURE 2: 75 mg or 150 mg SC at 0, 1, 2, 3, and 4 weeks, then Q4W
Half-life of ~ 27 days
MEASURE 1 [42] MEASURE 2 [42] MEASURE 1: ASAS20 at week 16
• Secukinumab 75 mg: 60% (P < 0.001)
• Secukinumab 150 mg: 61% (P < 0.001)
• Placebo: 29%
MEASURE 2: ASAS20 at week 16
• Secukinumab 75 mg: 41% (P = 0.10)
• Secukinumab 150 mg: 61% (P < 0.001)
• Placebo: 28%
• Serious infections
• Inflammatory bowel disease
• Anaphylaxis or serious allergic reactions
  1. q2w every 2 weeks, q4w every 4 weeks, IL, interleukin, nr-axSpA non-radiographic axial spondyloarthritis, SC subcutaneously, TNF tumor necrosis factor