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Table 6 Overview of bDMARDs and JAK inhibitors approved in adult and paediatric rheumatology (March 2020)

From: Biologic disease modifying antirheumatic drugs and Janus kinase inhibitors in paediatric rheumatology – what we know and what we do not know from randomized controlled trials

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) 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 (2013)
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  
  1. 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)
  2. 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
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