Journal of Clinical and Aesthetic Dermatology

Psoriasis and Cutaneous Supplement 2016

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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S 1 4 S U P P L E M E N T T O T H E J O U R N A L O F C L I N I C A L A N D A E S T H E T I C D E R M AT O L O G Y [ S E P T E M B E R 2 0 1 6 • V O L U M E 9 • N U M B E R 9 ] TABLE 6. Eight selected clinical trials published in 2015 with important findings for psoriasis* STUDY AGENT/DOSE EFFICACY SAFETY OF NOTE Kopp 95 P hase 1 rising multiple-dose, three-part study Tildrakizumab 3 or 10mg/kg PASI 75 achieved by 100% in parts 1 and 3 of this study by Day 196 Well tolerated This study shows I L-23 is crucial in the pathogenesis of psoriasis Krueger 28 Phase 1, single- rising dose Single IV dose of BI-655066 or same agent subcutaneously PASI 75, 90, and 100 were achieved by 87%, 58%, and 16% of active treatment patients at 12 weeks vs. none in placebo AEs with BI-655066 similar to placebo Results durable for 66 wk after single IV dose Papp 96 Phase 2a, three part Subcutaneous tildrakizumab, 5, 25, 100, or 200mg or placebo on Weeks 0 and 4 (part 1), then every 12 weeks thereafter until Week 52 (part 2), at which point the drug was discontinued and patients observed through Week 72 (part 3) PASI 75 was achieved by 33.3% (5mg), 64.4% (25mg), 66.3% (100mg), and 74.4% (200mg) and 4.4% (placebo) at 16 weeks (p<0.001 for all groups vs. placebo) Generally well tolerated but possible drug- related SAEs were observed (bacterial arthritis, lymphedema, melanoma, stroke, epiglottis and knee infection) Most PASI 75 patients could maintain this response through Week 52; only 8/222 participants who reached 72 wk relapsed Gordon 26 Phase 2 dose-ranging active-comparator study (adalimumab) Guselkumab in 4 dose groups: (1) 5mg at Weeks 0 and 4, then every 12 wk thereafter; (2) 50mg at Weeks 0 and 4 and every 12 wk thereafter; (3) 100mg every 8 wk; or (4) 200mg at Weeks 0 and 4 and every 12 wk thereafter. Adalimumab group doses at standard therapeutic levels, also placebo group PGA scores of 0–1 were achieved by significantly more guselkumab patients than placebo (34% for 5mg, 61% for 15mg, 79% for 50mg, 86% for 100mg, 83% for 200mg) vs. 7% placebo (p≤0.05 for all comparisons). More guselkumab patients achieved PASI 75 scores or better at 16 wk (p<0.001 for all comparisons) and at Week 40, significantly more patients had PGA 0–1 in the 50, 100, and 200mg guselkumab groups than in the adalimumab groups (71%, 77%, 81%, respectively, vs. 49%, p<0.05 for all comparisons) From Weeks 0 to 16, infections occurred at a rate of 20% in all guselkumab groups, 12% in the adalimumab group, and 14% in the placebo patients Griffiths 31 Results reported from two Phase 3 double- blind studies (UNCOVER-2 and -3) Subcutaneous placebo, etanercept (50mg twice weekly) or one injection of 80mg ixekizumab every 2 wk or every 4 wk following a 160mg starting dose Both ixekizumab dose regimens were more effective than placebo and etanercept in 2 studies for proportion of patients achieving PASI 75 SAEs were reported in about 2% of all patients (all groups, ixekizumab, etanercept, placebo) Lebwohl 94 Results from two Phase 3 studies (AMAGINE-2 and -3) Brodalumab (210 or 140mg every 2 wk) or ustekinumab (45mg or 90mg, based on weight), or placebo for 12 wk; at Week 12 brodalumab patients were randomly assigned to 210 or 150mg maintenance doses every 2, 4, or 8 wk; placebo patients were changed to 210mg brodalumab every 2 wk PASI 75 response rates were higher with brodalumab 210 (86%–85%) and 140 (67%–69%) mg doses (AMAGINE 2- and 3 results, respectively) compared to placebo (6%), p<0.001. PASI 100 response rates were significantly higher with 210mg brodalumab than ustekinumab (44% vs. 22% or 37% vs. 19%) Mild or moderate candida infections occurred more often with brodalumab than ustekinumab or placebo, serious infection rates through 52 wk were around 1% with brodalumab *Note that studies are named after the first author. Griffiths and Lebwohl each report on two studies in their papers. All studies were randomized, placebo- controlled trials. AE=adverse event; IV=intravenous; kg=kilogram; mg=milligram; PGA=Physician's Global Assessment; SAE=serious adverse event; wk=week

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