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. 2020 Aug 11;84(3):676–690. doi: 10.1016/j.jaad.2020.08.026

Table I.

Characteristics of randomized controlled trials of IL-12/23 or IL-23 antagonists∗

Drugs Target Disease References Age, y Sex, % male Study duration, wk Concomitant therapies during trials Regimen, mg (unless noted otherwise) Jadad score Patients, N
 RTIs, n
 Infectious pneumonia, n
 Noninfectious ILD, n
IL-12/23 Placebo IL-12/23 Placebo IL-12/23 Placebo IL-12/23 Placebo
Brazikumab IL-23 CD Sands et al (2017)11 37 38 12 Yes 700 IV at wk 0, 4 5 59 60 9 11 0 0 0 0
Guselkumab IL-23 Psoriasis Ohtsuki et al (2018)33 50 68 16 No 50, 100 SC at wk 0, 4, 12 5 128 64 22 7 0 0 0 0
†NCT0290533120 46 68 16 No 100 SC at wk 0, 4, 12 4 62 16 13 1 0 0 0 0
Nemoto et al (2018)34 NA 60 24 No 10, 30, 100, 300 SC (s) 5 20 4 2 0 0 0 0 0
Blauvelt et al (2017)35 44 73 16 No 100 SC at wk 0, 4, 12 5 329 174 55 26 0 0 0 0
Reich et al (2017)10 44 70 16 No 100 SC at wk 0, 4, 12 5 494 248 51 26 0 0 0 0
Gordon et al (2015)9 44 72 16 No 5, 50, 200 SC at wk 0, 4, q12 wk; 15, 100 SC q8 wk 5 207 42 25 3 0 0 0 0
PPP Sofen et al (2014)36 43 63 24 No 10, 30, 100, 300 SC (s) 4 20 4 5 0 0 0 0 0
Healthy volunteer Terui et al (2018)37 52 29 24 No 200 SC at wk 0, 4 5 25 24 8 9 0 0 0 0
Zhuang et al (2016)38 27 96 16 No 0.03, 0.1, 0.3, 1, 3, 10 mg/kg IV; 3 mg/kg SC (s) 5 36 11 5 1 0 0 0 0
Risankizumab IL-23 Psoriasis Gordon et al (2018)7 48 71 16 No 150 SC at wk 0, 4 5 304 102 37 8 0 0 0 0
Gordon et al (2018)7 47 68 16 No 150 SC at wk 0, 4 5 294 98 21 4 0 0 0 0
Krueger et al (2015)39 42 81 24 No 0.01, 0.05, 0.25, 1, 3, 5 mg/kg IV; 0.25, 1 mg/kg SC (s) 5 31 8 11 2 0 0 0 0
Ankylosing spondylitis Baeten et al (2018)64 38 70 16 Yes 18 SC (s); 90, 180 SC at wk 0, 8, 16 5 119 40 31 5 0 0 0 0
CD Feagan et al (2017)8 39 37 12 Yes 200, 600 IV at wk 0, 4, 8 5 82 39 10 5 1 1 0 0
Tildrakizumab IL-23 Psoriasis Reich et al (2017)5 46 67 12 No 100, 200 SC at wk 0, 4 5 617 154 69 17 0 0 0 0
Reich et al (2017)5 46 71 12 No 100, 200 SC at wk 0, 4 5 621 156 76 12 0 0 0 0
Papp et al (2015)6 43 74 16 No 5, 25, 100, 200 SC at wk 0, 4, 16 5 308 45 63 11 0 0 0 0
Healthy volunteer Khalilieh et al (2018)40 26 38 28 No 0.1, 0.5, 3, 10 mg/kg IV (s) 5 22 7 0 0 0 0 0 0
Khalilieh et al (2018)40 27 62 20 No 50, 200 SC (s) 5 28 9 0 0 0 0 0 0
Briakinumab IL-12
IL-23		 Psoriasis Gordon et al (2012)1 46 69 12 No 200 SC wk 0, 4; 100 SC wk 8 5 981 484 114 40 2 0 0 0
Gottlieb et al (2011)41 43 67 12 No 200 SC wk 0, 4; 100 SC wk 8 5 138 68 19 8 0 0 0 0
Strober et al (2011)42 45 64 12 No 200 SC wk 0, 4; 100 SC wk 8 5 139 72 20 6 0 0 0 0
Kimball et al (2008)43 46 75 12 No 200 SC (s); 100 SC q2wks for 12 wk; 200 SC q1wk for 4 wk; 200 SC q2wks or q1wk for 12 wk 5 150 30 38 3 0 0 0 0
CD Panaccione et al (2015)2 36 51 12 Yes 200, 400, 700 IV at wk 0, 4, 8 5 200 46 0 0 0 0 0 0
Mannon et al (2004)44 43 25 28 Yes 1, 3 mg/kg SC at wk 0; q1wk from wk 4 to 10 5 32 8 2 0 0 0 0 0
Mannon et al (2004)44 40 20 25 Yes 1, 3 mg/kg SC q1wk for 7 wk 5 31 8 2 0 0 0 0 0
MS Vollmer et al (2011)45 47 25 24 No 200 SC q2wk; 200 SC q1wk 5 146 69 51 29 0 0 0 0
Ustekinumab IL-12
IL-23		 Psoriasis Gordon et al (2018)7 48 71 16 No 45 SC (wt ≤ 100 kg); 90 SC (wt > 100 kg) at wk 0, 4 5 100 102 12 8 0 0 0 0
Gordon et al (2018)7 47 68 16 No 45 SC (wt ≤ 100 kg), 90 SC (wt > 100 kg) at wk 0, 4 5 99 98 9 4 0 0 0 0
Landells et al (2015)46 15 49 12 No 0.75 mg/kg SC (wt ≤ 60 kg); 45 SC (60 < wt ≤ 100 kg); 90 SC (wt > 100 kg); 0.375 mg/kg SC (wt ≤ 60 kg); 22.5 SC (60 < wt ≤ 100 kg); 45 SC (>100 kg) at wk 0, 4 5 73 37 16 13 0 0 0 0
Lebwohl et al (2015)47 45 69 12 No 45 SC (wt ≤ 100 kg); 90 SC (wt > 100 kg) at wk 0, 4 5 300 309 38 37 0 0 0 0
Lebwohl et al (2015)47 45 68 12 No 45 SC (wt ≤ 100 kg), 90 SC (wt > 100 kg) at wk 0, 4 5 313 313 32 39 0 0 0 0
Zhu et al (2013)48 40 77 12 No 45 SC at wk 0, 4 5 160 161 28 21 0 0 0 0
Igarashi et al (2012)61 46 80 12 No 45, 90 SC at wk 0, 4 5 126 32 21 4 0 0 1 0
Tsai et al (2011)49 40 85 12 No 45 SC at wk 0, 4 5 61 60 12 10 0 0 0 0
Papp et al (2008)3 45 69 12 No 45, 90 SC at wk 0, 4 5 820 410 119 59 1 1 0 0
Leonardi et al (2008)50 45 69 12 No 45, 90 SC at wk 0, 4 5 510 255 109 52 0 1 0 0
Krueger et al (2007)51 46 59 20 No 45, 90 SC at wk 0, q4wk 5 252 67 95 24 1 0 0 0
PsA Ritchlin et al (2014)62 49 47 16 Yes 45, 90 SC at wk 0, 4, 16 5 207 104 31 15 0 0 0 1
Mclnnes et al (2013)52 48 52 16 Yes 45, 90 SC at wk 0, 4, 16 5 409 205 33 18 0 0 0 0
Gottlieb et al (2009)53 50 59 12 Yes 90 SC q1wk for 4 wk 5 76 70 20 12 0 0 0 0
CD Feagan et al (2016)54 37 40 8 Yes 130 mg, 6 mg/kg IV (s) 5 495 245 23 13 0 0 0 0
Feagan et al (2016)54 39 50 8 Yes 130 mg, 6 mg/kg IV (s) 5 419 208 24 10 0 0 0 0
Sandborn et al (2012)4 39 41 8 Yes 1, 3, 6 mg/kg IV (s) 5 394 132 41 8 0 0 0 0
Sandborn et al (2008)55 40 55 8 Yes 90 SC at wk 0, 1, 2, 3; 4.5 mg/kg IV at wk 0 5 52 52 6 3 0 0 0 0
Atopic dermatitis Khattri et al (2017)56 37 63 16 No 45 SC (wt ≤ 100 kg), 90 SC (wt > 100 kg) at wk 0, 4, 16 5 16 16 2 1 0 0 0 0
Saeki et al (2017)51 39 71 24 No 45, 90 SC at wk 0, 4 5 52 27 15 7 0 0 0 0
GVHD †NCT0171340021 53 63 52 Yes 45 SC (wt ≤ 100 kg), 90 SC (wt > 100 kg) at day -1 and day 20 after transplantation 5 15 15 1 3 0 0 0 0
SLE van Vollenhoven et al (2018)58 40 3 24 Yes 260 (wt 35-55 kg), 390 (55 < wt ≤ 85), 520 (wt > 85 kg) IV wk 0; 90 SC q8wk 5 60 42 21 12 1 0 0 0
Sarcoidosis Judson et al (2014)63 50 51 44 Yes 180 SC wk 0; 90 SC wk 8, 16, 24 5 60 58 40 35 3 0 1 0
MS Segal et al (2008)59 37 36 37 No 27, 90, 180 SC wk 0, 1, 2, 3, 7, 11, 15, 1990 SC q8wks 5 200 49 73 17 0 0 0 0
PPPP Bissonnette et al (2014)60 55 10 16 No 45 SC (wt < 100 kg), 90 SC (wt ≥ 100 kg) at wk 0, 4, 16 5 10 10 0 0 0 0 0 0
PPP Bissonnette et al (2014)60 50 0 16 No 45 SC (wt < 100 kg); 90 SC (wt ≥ 100 kg) at wk 0, 4, 16 5 5 8 0 1 0 1 0 0

CD, Crohn's disease; GVHD, graft-versus-host disease; IL, interleukin; ILD, interstitial lung disease; IV, intravenous; MS, multiple sclerosis; NA, not available; PPP, palmoplantar pustulosis; PPPP, palmoplantar pustular psoriasis; PsA, psoriatic arthritis; q, every; RTI, respiratory tract infection; (s), single dose; SC, subcutaneous; SLE, systemic lupus erythematosus; wt, weight.

∗

Regarding age and sex, data from overall patients in each trials or patients treated IL-12/23 or IL-23 antagonists were used.

†

This study was registered in ClinicalTrails.gov but later became available as an article.