Breakthrough Drugs in Dermatology. Mark Lebwohl, MD

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1 Breakthrough Drugs in Dermatology Mark Lebwohl, MD Sol and Clara Kest Professor And Chairman Kimberly and Eric J. Waldman Department of Dermatology Icahn School of Medicine at Mount Sinai

2 LIFE CHANGING MEDICATIONS New psoriasis therapies Dupilumab Omalizumab Vismodegib/Sonidegib JAK inhibitors New vitiligo therapies

3 Drugs for Psoriasis and Psoriatic Arthritis ETANERCEPT ADALIMUMAB INFLIXIMAB CERTOLIZUMAB GOLIMUMAB USTEKINUMAB SECUKINUMAB IXEKIZUMAB APREMILAST METHOTREXATE CYCLOSPORINE ACITRETIN BRODALUMAB GUSELKUMAB TILDRAKIZUMAB RISANKIZUMAB LY

4 Drugs for Psoriasis and Psoriatic Arthritis-ORAL ETANERCEPT ADALIMUMAB INFLIXIMAB CERTOLIZUMAB GOLIMUMAB USTEKINUMAB SECUKINUMAB IXEKIZUMAB APREMILAST METHOTREXATE CYCLOSPORINE ACITRETIN BRODALUMAB GUSELKUMAB TILDRAKIZUMAB RISANKIZUMAB LY

5 Drugs for Psoriasis and Psoriatic Arthritis- FEW INJECTIONS ETANERCEPT ADALIMUMAB INFLIXIMAB CERTOLIZUMAB GOLIMUMAB USTEKINUMAB SECUKINUMAB IXEKIZUMAB APREMILAST METHOTREXATE CYCLOSPORINE ACITRETIN BRODALUMAB GUSELKUMAB TILDRAKIZUMAB RISANKIZUMAB LY

6 Drugs for Psoriasis and Psoriatic Arthritis LONG Hx & CARDIAC DISEASE ETANERCEPT ADALIMUMAB INFLIXIMAB CERTOLIZUMAB GOLIMUMAB USTEKINUMAB SECUKINUMAB IXEKIZUMAB APREMILAST METHOTREXATE CYCLOSPORINE ACITRETIN BRODALUMAB GUSELKUMAB TILDRAKIZUMAB RISANKIZUMAB LY

7 Drugs for Psoriasis and Psoriatic Arthritis OBESITY ETANERCEPT ADALIMUMAB INFLIXIMAB CERTOLIZUMAB GOLIMUMAB USTEKINUMAB SECUKINUMAB IXEKIZUMAB APREMILAST METHOTREXATE CYCLOSPORINE BRODALUMAB GUSELKUMAB TILDRAKIZUMAB RISANKIZUMAB LY

8 Drugs for Psoriasis and Psoriatic Arthritis-PSA ETANERCEPT ADALIMUMAB INFLIXIMAB CERTOLIZUMAB GOLIMUMAB USTEKINUMAB SECUKINUMAB IXEKIZUMAB APREMILAST METHOTREXATE CYCLOSPORINE BRODALUMAB GUSELKUMAB TILDRAKIZUMAB RISANKIZUMAB LY

9 Drugs for Psoriasis and Psoriatic Arthritis- FAST ETANERCEPT ADALIMUMAB INFLIXIMAB CERTOLIZUMAB GOLIMUMAB USTEKINUMAB SECUKINUMAB IXEKIZUMAB APREMILAST METHOTREXATE CYCLOSPORINE ACITRETIN BRODALUMAB GUSELKUMAB TILDRAKIZUMAB RISANKIZUMAB LY SPEED

10 Least squares mean % change in EASI from baseline Dupilumab Phase 2b Study: Mean Percent Change In EASI at Week 16 (LOCF ) Placebo Dupilumab 100 mg q4w Dupilumab 300 mg q4w Dupilumab 200 mg q2w Dupilumab 300 mg q2w Dupilumab 300 mg weekly Week P < vs placebo, Weeks P < 0.05 vs placebo, Weeks 1 2 and P < vs placebo, Weeks 3 16 P < 0.05 vs placebo, Week 1 and P < vs placebo, Weeks 2 16 LOCF imputation method for missing data and patients who received rescue medications. EASI: Eczema and Severity Index; LOCF: last observation carried forward; q2w: every 2 weeks; q4w: every 4 weeks. Adapted from Thaci D et al. Lancet. 2016;387(10013):40 52.

11 Omalizumab treatment reduced mean weekly Itch Severity Score by Week 1 Mean change from baseline Rapid-onset, dose-response, sustained efficacy at Wk 24 compared with Wk 12 0 Placebo Omalizumab 70 mg Omalizumab 150 mg Omalizumab 300 mg Study week 4-weekly injections Maurer M, et al. EADV 2013: FC09.1. Sponsored by Genentech, Inc. and Novartis

12 Inhibition of the hedgehog pathway in advanced basal-cell carcinoma. Von Hoff DD et al. N Engl J Med. 2009;361(12): patients metastatic or advanced BCC GDC 044a 16 partial and 2 complete responses fatigue, hyponatremia, muscle spasm, afib

13 Randomized, double-blind study of sonidegib (LDE225) in patients with locally advanced or metastatic basal-cell carcinoma J Clin Oncol 32:5s, 2014 (suppl; abstr 9009a^) MR Migden, etal SONIDEGIB

14 PGA response (SE) PASI75 response (%) PASI90 response (%) Comparison of tofacitinib vs ETN or PBO in moderate to severe chronic plaque psoriasis: Phase 3 RCT % patients achieving a PASI 75 response through Week 12 (NRI) % patients achieving a PASI 90 response through Week 12 (NRI) Week Week % patients achieving a PGA response through Week 12 (NRI) Valenzuela F, et al. AAD 2014, Week PBO (N=107) Tofa 5 mg BID (N=329) Tofa 10 mg BID (N=330) ETN 50 mg BIW (N=335)

15 Oral ruxolitinib induces hair regrowth in patients with moderate-to-severe alopecia areata. Mackay-Wiggan J, et al. JCI Insight. 2016;1:e Safety and efficacy of the JAK inhibitor tofacitinib citrate in patients with alopecia areata Kennedy Crispin M, et al.jci Insight. 2016;1:e Reversal of Alopecia Areata Following Treatment With the JAK1/2 Inhibitor Baricitinib. Jabbari A, et al. EBioMedicine. 2015;2:351-5.

16 Tofacitinib Citrate for the Treatment of Vitiligo: A Pathogenesis-Directed Therapy. Craiglow BG, King BA. JAMA Dermatol. 2015;151:1110-2

17 Preliminary clinical activity of a topical JAK1/2 inhibitor in the treatment of psoriasis. Punwani N, et al. J Am Acad Dermatol. 2012;67(4):

18 The efficacy of afamelanotide and narrowband UV-B phototherapy for repigmentation of vitiligo. Grimes PE, Hamzavi I, Lebwohl M, Ortonne JP, Lim HW. JAMA Dermatol. 2013;149:68-73.

19 AAD Practice Management Center Office of Access to Care and Treatment Rachna Chaudhari

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