30 5 th World Psoriasis & Psoriatic Arthritis Conference 2018
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Department of Dermatology, University of Texas, Houston, TX, 6 Department of Medicine( Dermatology) UCLA, Los Angeles, CA, 7 Sun Pharmaceutical Industries, Inc., Princeton, NJ, 8 Merck & Co., Inc., Kenilworth, NJ, USA
Introduction: Tildrakizumab( TIL) is a high-affinity, anti – interleukin-23p19 monoclonal antibody for the treatment of chronic plaque psoriasis. Objectives: We assessed a subgroup of patients with chronic plaque psoriasis who reported prior treatment with apremilast( APT), a phosphodiesterase 4 inhibitor, to evaluate its potential influence on efficacy in 2 large phase 3 clinical studies of tildrakizumab. Methods: The reSURFACE studies were 3-part, double-blind, randomized controlled studies in patients( ≥18 years of age) with moderate to severe chronic plaque psoriasis [ 1 ]. TIL 100 and 200 mg were evaluated for 64 weeks( reSURFACE 1; NCT01722331) and 52 weeks( reSURFACE 2; NCT01729754). Part 1( 0 – 12 weeks) was placebo( PBO)-controlled, whereas Part 2( 12 – 28 weeks) rerandomized PBO patients to TIL. The washout period for discontinuation of APT before randomization in these studies was 4 weeks. In this post hoc analysis, we analyzed the efficacy responses to TIL in patients who reported prior exposure to APT. Physicians’ Global Assessment( PGA)( 0 or 1) and Psoriasis Area and Severity Index( PASI) 75, 90, and 100 responses were assessed at Weeks 12 and 28 in this cohort. One patient with missing data at Weeks 12 and 28 was considered to be a nonresponder at these visits. The TIL groups were pooled owing to the small numbers reporting prior APT exposure. Results: The pooled reSURFACE 1 and 2 dataset includes 1238 patients randomized to TIL; of these, prior APT exposure was reported by 35 patients( n = 21 for 100 mg and n = 14 for 200 mg). In the overall pooled population of TIL-treated patients, PASI 75, PASI 90, PASI 100, and PGA( 0.1) responses were achieved by 783( 63 %), 450( 36 %), 161( 13 %), and 715( 58 %) at Week 12 and 898( 73 %), 647( 52 %), 303( 25 %), and 784( 63 %) at Week 28, respectively. In the population of TIL-treated patients with prior APT exposure, PASI 75, PASI 90, PASI 100, and PGA( 0.1) responses were achieved by 21( 60 %), 9( 26 %), 5( 14 %), and 22( 63 %) at Week 12 and 27( 77 %), 16( 46 %), 7( 20 %), and 22( 63 %) at Week 28, respectively. There were no discontinuations due to adverse events( AEs) among patients with prior APT exposure. Conclusions: Efficacy responses with TIL were similar for the small sample of patients with prior exposure to APT and the overall pooled population from reSURFACE 1 and reSURFACE 2. These results were consistent with the notion that no adverse effect on efficacy or discontinuations due to AEs are expected when initiating treatment with TIL among patients with prior exposure to APT. Reference: 1. Reich K, et al. Lancet. 2017; 390:276 – 288. Acknowledgements: The studies were funded by Merck Sharp & Dohme, Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Analyses were presented at the American Academy of Dermatology Annual Meeting, February 16 – 20, 2018, San Diego, CA, USA.
P066 RISANKIZUMAB EFFICACY / SAFETY IN MODERATE- TO-SEVERE PLAQUE PSORIASIS: 16-WEEK RESULTS
FROM IMMHANCE Andrew Blauvelt 1, Kim A. Papp 2, Melinda Gooderham 3, Richard G. Langley 4, Craig Leonardi 5, Jean-Philippe Lacour 6, Sandra Philipp 7, Stephen Tyring 8, Michael Bukhalo 9, Jashin J. Wu 10, Jerry Bagel 11, Ellen H. Frankel 12, David Pariser 13, Mary Flack 14, Joseph Scherer 14, Ziqian Geng 15, Yihua Gu 15, Anne Camez 16, Elizabeth H. Z. Thompson 17
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Oregon Medical Research Center, Portland, OR, 2 K Papp Clinical Research and Probity Medical Research, Waterloo, 3 School of Medicine, Queen’ s University, Kingston, and Centre for Dermatology and Probity Medical Research, Peterborough, ON, 4 Dalhousie University, Halifax, NS, Canada, 5 St. Louis University, St. Louis, MO, USA, 6 Hôpital de l’ Archet,
University of Nice – Sophia Antipolis, Nice, France, 7 Charité Universitätsmedizin Berlin, Berlin, Germany, 8 University of Texas Health Science Center and Center for Clinical Studies, Houston, TX, 9 Altman Dermatology Associates, Arlington Heights, IL, 10 Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA, 11 Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ, 12 RISkinDoc, Cranston, RI, 13 Eastern Virginia Medical School and Virginia Clinical Research Inc, Norfolk, VA, 14 Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, 15 AbbVie Inc., North Chicago, IL, USA, 16 AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany, 17 AbbVie Inc., Redwood City, CA, USA
Introduction: Interleukin-23( IL-23), a key regulator of multiple effector cytokines( including IL-17, IL-22, and TNF), is thought to drive the development and maintenance of psoriatic lesions. Risankizumab is a potent humanized IgG1 monoclonal antibody that inhibits IL-23 by specifically binding its p19 subunit. Objectives: To report efficacy and safety results of risankizumab from initial 16-week( wk) placebo( PBO)-controlled period of IMMhance trial in patients( pts) with moderate-to-severe chronic plaque psoriasis( PsO). Methods: IMMhance( NCT02672852) is a phase 3 multicenter, randomized, double-blind, PBO-controlled trial, evaluating the efficacy and safety of risankizumab versus PBO in pts with moderate-to-severe chronic plaque PsO. The initial 16-wk PBOcontrolled period( 507 pts, stratified by weight and prior TNFiexposure, randomized 4:1 to receive either risankizumab [ 150 mg at wks 0 and 4 ] or PBO) was followed by randomized withdrawal and subsequent re-treatment with risankizumab. Co-primary endpoints were PASI 90 and sPGA 0 / 1 responses at wk 16; missing data were imputed as non-responders. Results: At baseline, the mean age and weight were 49.2 years and 92.0 kg, respectively; 70.2 % of pts were male. A history of diagnosed or suspected psoriatic arthritis was reported in 34.7 % of pts and prior TNFi therapy was reported in 36.5 % of pts. Mean baseline PASI and BSA were 20.2 and 26.1 %, respectively. At wk 16, all primary and ranked secondary endpoints were met( p < 0.001). At Wk 16, risankizumab-treated pts achieved significantly higher PASI 90( 73.2 %) and sPGA 0 / 1( 83.5 %) response rates versus PBO-treated pts( 2.0 %; 7.0 %). Treatment-emergent adverse events( TEAEs) and serious AEs were reported in 45.5 % and 2.0 % of risankizumab-treated pts, respectively. Through 16 wks, there were no deaths, major adverse cardiovascular events, or cases of tuberculosis in risankizumab-treated pts. Conclusions: Risankizumab was superior to PBO in the treatment of adult pts with moderate-to-severe plaque PsO. The safety profile was consistent with previously reported risankizumab trials with no new or unexpected safety findings.
P067 DISEASE SEVERITY AND EFFICACY INSIGHTS: PATIENT-LEVEL PASI SCORES IN TILDRAKIZU MAB
PSORIASIS TRIALS Kenneth Gordon 1, Jeffrey Crowley 3, Yves Poulin 3, Alan Mendelsohn 4, Jeff Parno 4, Stephen Rozzo 4, Charles Ellis 5
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Medical College of Wisconsin, Milwaukee, WI, 2 Bakersfield Dermatology & Skin Cancer Medical Group, Bakersfield, USA, 3 Centre hospitalier de l’ université Laval, Hôpital Hôtel-Dieu de Québec, Québec City, Canada,
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Sun Pharmaceutical Industries, Inc., Princeton, 5 Department of Dermatology, University of Michigan Medical School, Ann Arbor, USA
Introduction: Tildrakizumab( TIL) is a high-affinity anti – IL-23p19 antibody that showed efficacy in 2 phase 3 chronic plaque psoriasis studies( reSURFACE 1 [ NCT01722331 ] and 2 [ NCT01729754 ]) [ 1 ]. Some dichotomous efficacy measures, eg, proportions of patients achieving a 75 % Psoriasis Area and Severity Index( PASI) response, provide limited efficacy and disease severity information at a patient level. Analysis of patient-level PASI data could address these limitations. Objective: To identify potential insights into efficacy assessment www. medicaljournals. se / acta