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: 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 |