33354 Efficacy of apremilast in patients with mild to moderate psoriasis assessed by the physician global assessment and body surface area composite tool: Post hoc analysis from ADVANCE

Background: In ADVANCE (NCT03721172), apremilast 30 mg BID (APR) demonstrated significantly greater sPGA response vs. PBO at Week 16 (22% vs. 4%; P \u3c.0001) in patients with mild-to-moderate psoriasis. The Physician Global Assessment and Body Surface Area Composite Tool (PGA × BSA) is a simple, sensitive measure of psoriasis severity for patients with BSA\u3c10%. We performed a post hoc analysis of the efficacy results from ADVANCE using the PGA×BSA. Methods: This current post hoc analysis included all randomized patients. Missing data were imputed by multiple imputation. PGAxBSA-50/75/90 was 50%, 75% and 90% improvement in PGAxBSA from baseline. Results: Of 595 randomized patients (APR: 297; PBO: 298), baseline characteristics were similar for mean BSA (APR: 6.4; PBO: 6.3), sPGA score 2 (APR 31%; PBO: 31%), sPGA score 3 (APR: 69%; PBO: 70%), and mean PGA×BSA (APR: 17.6; PBO: 17.5). At Week 16, significantly more patients achieved PGAxBSA-50/75/90 response with APR vs. PBO: PGA×BSA-50, 67% vs. 26% (P \u3c.0001), difference 41%, 95%CI (32.7,48.5) PGA×BSA-75, 46% vs. 13% (P \u3c.0001), difference 33%, 95%CI (25.8,40.2) PGA×BSA-90, 27% vs. 3% (P \u3c.0001), difference 24%, 95%CI (18.3,29.6) A significant improvement from baseline at Week 16 in PGA×BSA was observed with APR vs PBO: Mean % change (SE) in PGA×BSA, -51.8 (4.2) vs. 1.97 (4.3); difference (95%CI): -53.8 (-65.4, -42.2), P \u3c.0001. Conclusions: The PGA×BSA Composite Tool appeared to be a sensitive and a relevant measure for mild-to-moderate psoriasis that showed significantly greater treatment differences at 50%, 75%, and 90% response thresholds at Week 16 with APR compared with PBO in ADVANCE

26085 Key efficacy and safety of apremilast in patients with mild to moderate plaque psoriasis in the phase 3 ADVANCE trial

Background: In ADVANCE, apremilast 30 mg BID (APR) demonstrated efficacy in mild-to-moderate psoriasis vs placebo (PBO). We report subgroup analyses by baseline psoriasis-involved BSA (≤5%, \u3e5%). Methods: Biologic-naive adults with mild-to-moderate psoriasis (sPGA 2-3, BSA 2%-15%, PASI 2-15) inadequately controlled with or intolerant to ≥1 topical were randomized to APR or PBO for 16 weeks. At Week 16, endpoints were compared between treatment groups and by baseline BSA. Results: At baseline, 284 patients had BSA ≤5% (APR: 143; PBO: 141); 311 had BSA \u3e5% (APR: 154; PBO: 157). Overall, a greater proportion of APR patients achieved the primary endpoint, sPGA response (score 0/1 [clear/almost clear] with ≥2-point reduction at Week 16) vs PBO (21.6% vs 4.1%, P 5%: 54.6% vs 14.9%, P 5%: 45.4% vs 17.6%, P 5%: 50.6% vs 19.2%, P 5%: 11.0 vs 10.0 DLQI 5-point improvement (baseline DLQI \u3e5): - BSA≤5%: 56.6% vs 31.2%, P =.0002 - BSA\u3e5%: 64.4% vs 36.4%, P ˂.0001. Conclusions: Greater proportions of patients achieved efficacy outcomes and greater improvements in QOL with APR vs PBO. Comparable improvements were observed between mild and moderate subgroups

Erratum to : Secukinumab is Efficacious and Safe in Hispanic Patients with Moderate-to-Severe Plaque Psoriasis: Pooled Analysis of Four Phase 3 Trials

Introduction: There is little evidence available on the efficacy and safety of biologic therapies for the treatment of psoriasis in Hispanic patients. Secukinumab is demonstrated to be highly effective for clearing psoriasis. The aim of this study was to compare the efficacy and safety of secukinumab in Hispanic and non-Hispanic patients. Methods: Data were pooled from four phase 3 studies of secukinumab in patients with moderate-to-severe plaque psoriasis. Patients who self-identified as Hispanic were included in the Hispanic subgroup.Results: Efficacy responses (Psoriasis Area and Severity Index [PASI] 75/90/100 and Investigator's Global Assessment 2011 modified version 0/1) for secukinumab 300 mg were greater than for etanercept at week 12 in the Hispanic and non-Hispanic patient subgroups. At week 12 with secukinumab 300 mg, PASI 90/100 responses were achieved by 70.6%/35.9% of Hispanic patients and 58.0%/28.1% of non-Hispanic patients. At week 12 with secukinumab 150 mg, PASI 90/100 responses were achieved by 59.5%/25.1% of Hispanic patients and 41.2%/13.4% of non-Hispanic patients. In both subgroups, peak efficacy responses with secukinumab were observed at week 16 and were maintained to week 52.Conclusions: Secukinumab is highly effective for clearing psoriasis in both Hispanic and non-Hispanic patients.Funding: Novartis Pharmaceutical Corporation

Secukinumab is Efficacious and Safe in Hispanic Patients with Moderate-to-Severe Plaque Psoriasis : Pooled Analysis of Four Phase 3 Trials

Altres ajuts: This study was funded by Novartis Pharmaceutical Corporation. Article processing charges and the fee for open access were funded by Novartis Pharmaceutical Corporation. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. Technical assistance with editing and styling of the manuscript for submission was provided by Scott Forbes, Ph.D., of Oxford PharmaGenesis Inc. and was funded by Novartis Pharmaceuticals Corporation.There is little evidence available on the efficacy and safety of biologic therapies for the treatment of psoriasis in Hispanic patients. Secukinumab is demonstrated to be highly effective for clearing psoriasis. The aim of this study was to compare the efficacy and safety of secukinumab in Hispanic and non-Hispanic patients. Data were pooled from four phase 3 studies of secukinumab in patients with moderate-to-severe plaque psoriasis. Patients who self-identified as Hispanic were included in the Hispanic subgroup. Efficacy responses (Psoriasis Area and Severity Index [PASI] 75/90/100 and Investigator's Global Assessment 2011 modified version 0/1) for secukinumab 300 mg were greater than for etanercept at week 12 in the Hispanic and non-Hispanic patient subgroups. At week 12 with secukinumab 300 mg, PASI 90/100 responses were achieved by 70.6%/35.9% of Hispanic patients and 58.0%/28.1% of non-Hispanic patients. At week 12 with secukinumab 150 mg, PASI 90/100 responses were achieved by 59.5%/25.1% of Hispanic patients and 41.2%/13.4% of non-Hispanic patients. In both subgroups, peak efficacy responses with secukinumab were observed at week 16 and were maintained to week 52. Secukinumab is highly effective for clearing psoriasis in both Hispanic and non-Hispanic patients. Novartis Pharmaceutical Corporation. The online version of this article (doi:10.1007/s12325-017-0521-z) contains supplementary material, which is available to authorized users

Certolizumab Pegol for the treatment of chronic plaque psoriasis: results through 48 weeks of a phase 3, multicenter, andomized, double-blinded, etanercept- and placebo-controlled study (CIMPACT)

Background Phase 2 psoriasis studies with the Fc-free, PEGylated, anti-tumor necrosis factor biologic certolizumab pegol demonstrated meaningful clinical activity. Objective Assess safety and efficacy of certolizumab in adults with moderate-to-severe chronic plaque psoriasis. Methods Patients were randomized 3:3:1:3 to certolizumab 400 mg, 200 mg, or placebo every 2 weeks for 16 weeks or etanercept 50 mg twice-weekly for 12 weeks. Certolizumab-treated patients achieving ≥75% reduction in psoriasis area and severity index at Week 16 were re-randomized to certolizumab or placebo for 32 weeks. The primary endpoint was responder rate (≥75% reduction in psoriasis area and severity index) versus placebo (primary analysis) and etanercept (secondary analysis) at Week 12; secondary endpoints included responder rates on various measures versus placebo at Weeks 12, 16, and 48. Safety was assessed by treatment-emergent adverse events. Results All endpoints were significantly greater for certolizumab versus placebo with the greatest response seen with 400 mg. Certolizumab 400 mg was superior to and 200 mg was noninferior to etanercept. Adverse events were consistent with the anti-tumor necrosis factor class. Limitations Single-blind etanercept. Conclusion Both certolizumab regimens improved psoriasis symptoms with greater response at the higher dose. No new safety signals were observed

Efficacy and safety of lebrikizumab (an anti-IL-13 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical corticosteroids:A randomized, placebo-controlled phase II trial (TREBLE)

Documentos apresentados no âmbito do reconhecimento de graus e diplomas estrangeiro

Secukinumab provides better relief from the impact of psoriasis on daily activities and personal relationships than etanercept: results of two phase 3 placebo-controlled randomized clinical trials in moderate-to-severe psoriasis

Background: Psoriasis can greatly impact patients’ lives, influencing what clothing they wear and impairing their sexual functioning. Objective: To provide a detailed comparison of the impact of secukinumab vs. etanercept on enabling patients with psoriasis to have more normal lives with respect to daily activities (DA) (e.g. choosing clothing) and personal relationships (PR) (e.g. sexual functioning). Methods: Baseline to Week 52 ERASURE and FIXTURE data for secukinumab 300 mg and etanercept were analyzed. Treatment differences in mean scores on the DA and PR subscales and items from the Dermatology Life Quality Index were compared. The proportions of subscale and item responders (score = 0) were compared. Results: Subjects receiving secukinumab (n = 572) achieved greater mean improvement in DA and items (q3 and q4) than subjects receiving etanercept (n = 326; all p < .01 through Week 52). Subjects receiving secukinumab achieved greater mean improvement in PR and items (q8 and q9) than subjects receiving etanercept (subscale: p < .05 at Weeks 8 and 12). Response rates were significantly higher for secukinumab than for etanercept for DA (all p < .0001) and PR (all p < .05 except Weeks 4 and 36). Conclusions: Secukinumab 300 mg provides greater improvements and more effective relief from psoriasis impact on DA and PR than etanercept