Table 6.
Overview of bDMARDs and JAK inhibitors approved in adult and paediatric rheumatology (March 2020)
| Drug class | Drug (brand name) |
Adults | Children | ||||
|---|---|---|---|---|---|---|---|
| Approved by FDA (date) | Approved by EMA (date) | Approved by FDA (date) | Current FDA age criteria | Approved by EMA (date) | Current EMA age criteria | ||
| Anti-CD20 agent | rituximaba (MabThera, Rituxan) | RA (2006), WG/MPA (2011) | RA(2006), GPA/MPA (2013) | GPA/MPA (2019) | ≥2 years | GPA/MPA (2020) | ≥2 years |
| CD80/86 inhibitor | abatacept (Orencia) | RA (2005), PsA (2017) | RA (2007), PsA (2017) | PJIA (2008) |
≥2 years (sc); ≥6 years (iv) |
PJIA (2009) | ≥2 years |
| IL-1 inhibitor | anakinra (Kineret) |
RA (2001) CINCA/NOMID (2012) |
RA (2002), CAPS (2013), AOSD (2018) | NOMID/CINCA (2012) | NA | CAPS (2013), SJIA (2018) | ≥8 months |
| canakinumab (Ilaris) | CAPS (2009), TRAPS/MKD/FMF (2016) | CAPS (2009), AOSD (2016), TRAPS/FMF/MKD (2016) |
CAPS (2009), SJIA (2013), TRAPS/ FMF/MKD (2016) |
≥4 years CAPS/TRAPS/MKD/ FMF; ≥2 years SJIA |
CAPS (2009), SJIA (2013), TRAPS/FMF/ MKD (2016) | ≥2 years | |
| rilonacept (Arcalyst) | CAPS (2008) | not approved | CAPS (2008) | ≥12 years | not approved | ||
| IL-6 inhibitor |
tocilizumabb (RoAcetemra/Actemra) |
RA (2010) | RA (2008) | SJIA (2011), PJIA (2013) | ≥2 years | SJIA (2011), PJIA (2013) |
≥1 years SJIA; ≥2 years PJIA |
| sarilumab (Kevzara) | RA (2017) | RA (2017) | not approved | not approved | |||
| IL-12/23 inhibitor | ustekinumabc (Stelara) | Plaque psoriasis (2009), PsA (2013) |
Plaque psoriasis (2008), PsA (2014) |
Plaque psoriasis (2017) | ≥12 years | Plaque psoriasis (2015) | ≥6 years |
| IL-23 inhibitor | guselkumab (Tremfya) | Plaque psoriasis (2017) | Plaque psoriasis (2017) | not approved | not approved | ||
| risankizumab (Skyrizi) | Plaque psoriasis (2019) | Plaque psoriasis (2019) | not approved | not approved | |||
| tildrakizumab (Ilumya/Ilumetri) | Plaque psoriasis (2018) | Plaque psoriasis (2018) | not approved | not approved | |||
| IL-17 inhibitor | brodalumab (Siliq, Kyntheum) | Plaque psoriasis (2017) | Plaque psoriasis (2017) | not approved | not approved | ||
| ixekizumab (Taltz) | Plaque psoriasis (2016), PsA (2017), AS (2019) | Plaque psoriasis (2016), PsA (2017) | Plaque psoriasis (2020) | ≥6 years | not approved | ||
| secukinumab (Cosentyx) |
Plaque psoriasis (2015), AS (2016), PsA (2016) |
Plaque psoriasis (2014), PsA (2015), AS (2015) |
not approved | not approved | |||
| TNF inhibitor | adalimumabd (Humira) | RA (2002), PsA (2005), AS (2006), plaque psoriasis (2008), non-infectious intermediate, posterior and panuveitis (2016) | RA (2003), PsA (2005), AS (2006), plaque psoriasis (2007), non-radiographic axial spondyloarthritis (2012), non-infectious intermediate, posterior and panuveitis (2016) | PJIA (2008) | ≥2 years | PJIA (2008), ERA (2014), plaque psoriasis (2015), non-infectious anterior uveitis (2017) |
≥2 years PJIA; ≥2 years uveitis; ≥4 years plaque psoriasis; ≥6 years ERA |
| certolizumab pegole (Cimzia) | RA (2009), PsA (2013), AS (2013), plaque psoriasis (2018), non-radiographic axial spondyloarthritis (2019) | RA (2009), PsA (2013), AS/non-radiographic axial spondyloarthritis (2013), plaque psoriasis (2018) | not approved | not approved | |||
| etanercept (Enbrel) | RA (1998), PsA (2002), AS (2003), plaque psoriasis (2004) | RA (2000), PsA (2002), AS (2004), plaque psoriasis (2004), non-radiographic axial spondyloarthritis (2014) | PJIA (1999), plaque psoriasis (2016) | ≥2 years PJIA; ≥4 years plaque psoriasis | PJIA (2001), plaque psoriasis (2008), ERA/PsA (2012) |
≥2 years PJIA; ≥6 years plaque psoriasis; ≥12 years ERA/PsA |
|
| golimumabf (Simponi) | RA/PsA/AS (2009) | RA/PsA/AS (2009), non-radiographic axial spondyloarthritis (2015) | not approved | PJIA (2016) | ≥2 years | ||
| infliximabg (Remicade) | RA (1999), AS (2004), PsA (2005), plaque psoriasis (2006) | RA (2000), AS (2003), PsA (2004), plaque psoriasis (2005) | not approved | not approved | |||
| BAFF inhibitor | belimumab (Benlysta) | SLE (2011) | SLE (2011) | SLE (2019) | ≥5 years | SLE (2019) | ≥5 years |
| JAK inhibitor | tofacitinib8 (Xeljanz) | RA (2012), PsA (2017) | RA (2017), PsA (2018) | not approved | not approved | ||
| baricitinib (Olumiant) | RA (2018) | RA (2016) | not approved | not approved | |||
| upadacitinib (Rinvoq) | RA (2019) | RA (2019) | not approved | not approved | |||
aAlso approved to treat Non-Hodgkin’s Lymphoma, chronic lymphatic leukemia and pemphigus vulgaris; bAlso approved to treat giant cell arteritis, cytokine release syndrome (≥2 years); cAlso approved to treat ulcerative colitis (FDA only), Crohn’s disease; dAlso approved to treat ulcerative colitis, Crohn’s disease (≥6 years), hidradenitis suppurativa (age ≥ 12 years); eAlso approved to treat Crohn’s disease (FDA only); fAlso approved to treat ulcerative colitis; gAlso approved to treat Crohn’s disease (≥6 years), ulcerative colitis (≥6 years); hAlso approved to treat ulcerative colitis (FDA only)
Abbreviations: AOSD adult-onset still’s disease, AS ankylosing spondyloarthritis/spondylitis, CAPS cryopyrin-associated periodic syndrome, CINCA chronic infantile neurologic, cutaneous, and arthritis, EMA European Medicines Agency, ERA enthesitis-related juvenile idiopathic arthritis, FDA Food and Drug Administration, FMF familial mediterranean fever, GPA granulomatosis with polyangiitis, IL interleukin, MKD mevalonate kinase deficiency, MPA microscopic polyangiitis, NA. not applicable, NOMID neonatal-onset multisystem inflammatory disease, PJIA polyarticular juvenile idiopathic arthritis, PsA psoriatic arthritis/ psoriatic juvenile idiopathic arthritis, RA rheumatoid arthritis, SJIA systemic juvenile idiopathic arthritis, SLE systemic lupus erythematosus, TNF tumor necrosis factor receptor-associated periodic syndrome, TRAPS tumour necrosis factor receptor-associated periodic syndrome, WG Wegner’s Granulomatosis