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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, 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

 
  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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Pediatric Rheumatology

ISSN: 1546-0096