Secukinumab efficacy in moderate to severe psoriasis appears not to be affected by previous biologic...
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P6400 Secukinumab efficacy in moderate to severe psoriasis appears not to be affected by previous biologic use: Results of a phase II, regimen-finding trial Mark Lebwohl, Mount Sinai School of Medicine, New York, NY, United States; Boni Elewski, University of Alabama, Birmingham, AL, United States; Charis Papavassilis, Novartis Pharma AG, Basel, Switzerland; Helen Jane Thurston, Novartis Pharma AG, Basel, Switzerland Background: Psoriasis is associated with increased levels of interleukin (IL)-17A. Herein, we report the relationship between response to treatment with secukinu- mab (anti-IL-17A monoclonal antibody) and previous biologic exposure in patients with moderate to severe plaque psoriasis. Methods: Patients (N ¼ 404) were randomized (1:2:2:1) to receive either placebo (n ¼ 67) or one of the 3 secukinumab 150 mg induction regimens subcutaneously: single (week 0; n ¼ 66), Early (weeks 0, 1, 2, 4; n ¼ 133), and monthly (weeks 0, 4, 8; n ¼ 138). Primary efficacy endpoint was achievement of PASI 75 response at week 12. The relationship between response to secukinumab treatment and prior biologic exposure was assessed as an exploratory endpoint. Results: 119 (29.5%) patients included in the study were previously exposed to biologics (TNF alpha antagonists, T-cell blockers, and IL-12/23 inhibitors). In the overall population, secukinumab early and monthly regimens achieved the primary endpoint at week 12. At week 12, PASI 75 response in patients with no previous exposure to biologics in the early and monthly induction regimens was (55.4%, 51/92) and (42.3%, 41/97) respectively, which was comparable with PASI 75 response in patients with (early: 52.4%, 11/21; monthly: 55.6%, 10/18) or without response to previously used biologics (early: 52.6%, 10/19; monthly: 30.4%, 7/23). In the single regimen, PASI 75 response was 11.1% (5/45), 10% (1/10), and 9.1% (1/11) in patients with no previous biologic exposure and in patients with or without previous biologic response, respectively. The placebo regimen did not show any response in patients without previous biologic therapy and in patients who did not respond to previous biologic therapy; 10% response was observed in patients who responded to previous biologic therapy. Serious adverse events and adverse events, including infections, were comparable between the secukinumab regimens and placebo during the induction period. Conclusion: These results suggest that secukinumab is beneficial for patients with moderate to severe plaque psoriasis irrespective of previous biologic use or previous biologic response. This study was sponsored by Novartis Pharma AG, Basel, Switzerland. P6394 Secukinumab efficacy in patients with moderate to severe plaque psoriasis and psoriatic arthritis: A phase II, double-blind, randomized trial Alice B. Gottlieb, Tufts Medical Center, Boston, MA, United States; Achim Guettner, Novartis Pharma AG, Basel, Switzerland; Charis Papavassilis, MD, PhD, Novartis Pharma AG, Basel, Switzerland; Philip Helliwell, University of Leeds, Leeds, United Kingdom Background: Psoriasis is accompanied by psoriatic arthritis (PsA) in 6% to 42% of patients, which makes treatment of these patients more challenging. Herein, we report the impact of presence or absence of PsA in patients with moderate to severe plaque psoriasis on treatment with secukinumab (fully human monoclonal antibody targeting interleukin [IL]-17A). The primary efficacy and safety data of this phase II study were presented earlier. Methods: Patients (N ¼ 404) were randomized (1:2:2:1) to either 1 of the 3 subcutaneous secukinumab 150-mg induction regimens: single (at week 0; n ¼ 66), early (at weeks 0, 1, 2, 4; n ¼ 133) and monthly (at weeks 0, 4, 8; n ¼ 138) or placebo (n ¼ 67). PASI 75 response at week 12 was the primary efficacy endpoint. PASI 75 response in moderate to severe plaque psoriasis patients with and without PsA at week 12 was assessed as an exploratory endpoint. Results: Baseline disease characteristics were comparable across treatment regi- mens. At baseline, mean PASI score was 20.3 6 7.99; 27.5% (n ¼ 111) patients suffered from PsA. At week 12, PASI 75 responses were statistically higher in early and monthly induction regimens versus placebo (54.5% and 42.0% vs 1.5%; P \.001 for both) in overall population. PASI 75 responses in psoriasis patients with and without PsA were higher in early and monthly induction regimens versus placebo (50.0% and 44.4% vs 0% for psoriasis patients with PsA and 56.4% and 40.9% vs 1.9% for psoriasis patients without PsA). Serious adverse events and adverse event rates (including infections) were comparable among all treatment arms during induction period. Conclusion: Clinically relevant improvement in subjects with moderate to severe plaque psoriasis was seen in patients with and without PsA. This study was sponsored by Novartis Pharma AG, Basel, Switzerland. P6395 Secukinumab reduces C-reactive protein levels in patients with moderate to severe plaque psoriasis: Result of a regimen-finding study Bruce Strober, University of Connecticut School of Medicine, Farmington, CT, United States; Achim Guettner, Novartis Pharma AG, Basel, Switzerland; Bardur Sigurgeirrson, University of Iceland, Reykjavik, Iceland; Charis Papavassilis, Novartis Pharma AG, Basel, Switzerland Background: Patients with psoriasis have high CRP levels, an inflammatory biomarker which indicates cardiovascular risk. Here we evaluated the effect of secukinumab, a fully human antieinterleukin-17A monoclonal antibody, on CRP levels in patients with moderate to severe plaque psoriasis. Efficacy and safety results of this study have been presented. Methods: 404 patients were randomized (1:2:2:1) to receive subcutaneous admin- istration of either placebo (n ¼ 67) or 1 of the 3 secukinumab 150-mg induction regimens: single (at week 0; n ¼ 66), early (at weeks 0, 1, 2, 4; n ¼ 133), and monthly (at weeks 0, 4, 8; n ¼ 138). The primary efficacy endpoint was the PASI 75 response at week 12. Inflammatory marker high sensitivity (hs) CRP was assessed as exploratory post-hoc analysis at week 0 and week 12. Results: At week 12, the median CRP levels reduced from 3.70 to 2.50 mg/L in the monthly regimen (P ¼ .026 vs placebo). Numerically greater reduction in median CRP levels was observed in the early regimen (3.00 to 2.00 mg/L, P ¼ .124 vs placebo). No significant change was observed in the single regimen (2.60 to 2.80 mg/L; P ¼.773 vs placebo) and placebo (3.00 to 3.05 mg/L). Conclusion: In this study, some doses of secukinumab led to more pronounced reductions in the CRP levels versus placebo, an indication that the inflammatory burden in patients with moderate to severe plaque psoriasis may be lowered during therapy. This study was sponsored by Novartis Pharma AG, Basel, Switzerland. P6871 Secukinumab treatment shows a neutral effect on the lipid profile of patients with moderate to severe plaque psoriasis: Results from a ran- domized, double-blind, placebo-controlled, phase II study Ulrich Mrowietz, Universit€ atsklinikum Schleswig-Holstein, Kiel, Germany; Abrar Qureshi, Harvard Medical School Brigham and Women’s Hospital, Boston, MA, United States; Cesar Escrig, Novartis Pharma AG, Basel, Switzerland; Hanno Richards, Novartis Pharma AG, Basel, Switzerland; Helen Thurston, Novartis Pharma AG, Basel, Switzerland Background: Plaque psoriasis is a chronic, relapsing, systemic immune-mediated disease associated with increased interleukin (IL)-17A levels. Secukinumab, a fully human antieIL-17A monoclonal antibody, has shown efficacy in the treatment of psoriasis. Herein, we report the effect of secukinumab on the lipid profile of patients with moderate to severe plaque psoriasis. Methods: In this phase II, double-blind, placebo-controlled trial, patients (N ¼ 125) with moderate to severe plaque psoriasis were randomized (1:1:1:1:1) to receive monthly subcutaneous doses of either placebo (n ¼ 22) or secukinumab (1 3 25 mg [n ¼ 29], 3 3 25 mg [n ¼ 26], 3 3 75 mg [n ¼ 21], 3 3 150 mg [n ¼ 27]) at weeks 0, 4, and 8; results of the 25-mg groups are not shown in this abstract. After 12 weeks of treatment, patients entered a follow-up period of 24 weeks. Secondary endpoints assessment included change in the lipid parameters (total cholesterol [TC], high- density lipoprotein cholesterol [HDLc], low-DLc [LDLc], and triglycerides [TG]) from baseline to week 36. Results: Demographics and baseline characteristics including body weight and lipid parameters were comparable across all treatment arms. Following 12 weeks of therapy, there was no effect of secukinumab on the lipid profile of patients compared with placebo and this was maintained throughout the study period (0-36 weeks). Mean change 6 SD (mmol/L) for secukinumab 3 3 75 mg and 3 3 150 mg groups from baseline to week 36 in TC (-0.006 6 0.66, 0.239 6 0.69), HDLc (-0.007 6 0.22, 0.120 6 0.16), LDLc (0.070 6 0.53, 0.149 6 0.57), and TG (-0.160 6 0.57, -0.227 6 1.22) showed no change compared with placebo (0.102 6 0.62, 0.091 6 0.32, 0.025 6 0.44, -0.025 6 0.74). Out of 5 SAEs, 3 cardiac SAEs (1 in 3 3 75 mg arm; 2 in placebo arm) and 1 death due to myocardial infarction in the placebo group were reported during week 0-36. Conclusion: In this study, secukinumab treatment was associated with a neutral lipid profile and appeared not to be associated with any changes in the TC, HDLc, LDLc, and TG lipid profile of patients with moderate to severe plaque psoriasis. This study was sponsored by Novartis Pharma AG, Basel, Switzerland. AB212 JAM ACAD DERMATOL APRIL 2013
Transcript of Secukinumab efficacy in moderate to severe psoriasis appears not to be affected by previous biologic...
P6400Secukinumab efficacy in moderate to severe psoriasis appears not to beaffected by previous biologic use: Results of a phase II, regimen-findingtrial
Mark Lebwohl, Mount Sinai School of Medicine, New York, NY, United States;Boni Elewski, University of Alabama, Birmingham, AL, United States; CharisPapavassilis, Novartis Pharma AG, Basel, Switzerland; Helen Jane Thurston,Novartis Pharma AG, Basel, Switzerland
Background: Psoriasis is associated with increased levels of interleukin (IL)-17A.Herein, we report the relationship between response to treatment with secukinu-mab (anti-IL-17A monoclonal antibody) and previous biologic exposure in patientswith moderate to severe plaque psoriasis.
Methods: Patients (N¼ 404) were randomized (1:2:2:1) to receive either placebo (n¼ 67) or one of the 3 secukinumab 150 mg induction regimens subcutaneously:single (week 0; n¼ 66), Early (weeks 0, 1, 2, 4; n¼ 133), andmonthly (weeks 0, 4, 8;n ¼ 138). Primary efficacy endpoint was achievement of PASI 75 response at week12. The relationship between response to secukinumab treatment and prior biologicexposure was assessed as an exploratory endpoint.
Results: 119 (29.5%) patients included in the study were previously exposed tobiologics (TNF alpha antagonists, T-cell blockers, and IL-12/23 inhibitors). In theoverall population, secukinumab early and monthly regimens achieved the primaryendpoint at week 12. At week 12, PASI 75 response in patients with no previousexposure to biologics in the early and monthly induction regimens was (55.4%,51/92) and (42.3%, 41/97) respectively, which was comparable with PASI 75response in patients with (early: 52.4%, 11/21; monthly: 55.6%, 10/18) or withoutresponse to previously used biologics (early: 52.6%, 10/19; monthly: 30.4%, 7/23).In the single regimen, PASI 75 response was 11.1% (5/45), 10% (1/10), and 9.1%(1/11) in patients with no previous biologic exposure and in patients with orwithout previous biologic response, respectively. The placebo regimen did notshow any response in patients without previous biologic therapy and in patientswho did not respond to previous biologic therapy; 10% response was observed inpatients who responded to previous biologic therapy. Serious adverse events andadverse events, including infections, were comparable between the secukinumabregimens and placebo during the induction period.
Conclusion: These results suggest that secukinumab is beneficial for patients withmoderate to severe plaque psoriasis irrespective of previous biologic use or previousbiologic response.
AB212
y was sponsored by Novartis Pharma AG, Basel, Switzerland.
This studP6394Secukinumab efficacy in patients with moderate to severe plaque psoriasisand psoriatic arthritis: A phase II, double-blind, randomized trial
Alice B. Gottlieb, Tufts Medical Center, Boston, MA, United States; AchimGuettner, Novartis Pharma AG, Basel, Switzerland; Charis Papavassilis, MD, PhD,Novartis Pharma AG, Basel, Switzerland; Philip Helliwell, University of Leeds,Leeds, United Kingdom
Background: Psoriasis is accompanied by psoriatic arthritis (PsA) in 6% to 42% ofpatients, which makes treatment of these patients more challenging. Herein, wereport the impact of presence or absence of PsA in patients with moderate to severeplaque psoriasis on treatment with secukinumab (fully human monoclonal antibodytargeting interleukin [IL]-17A). The primary efficacy and safety data of this phase IIstudy were presented earlier.
Methods: Patients (N ¼ 404) were randomized (1:2:2:1) to either 1 of the 3subcutaneous secukinumab 150-mg induction regimens: single (at week 0; n¼ 66),early (at weeks 0, 1, 2, 4; n¼ 133) andmonthly (at weeks 0, 4, 8; n¼ 138) or placebo(n ¼ 67). PASI 75 response at week 12 was the primary efficacy endpoint. PASI 75response in moderate to severe plaque psoriasis patients with and without PsA atweek 12 was assessed as an exploratory endpoint.
Results: Baseline disease characteristics were comparable across treatment regi-mens. At baseline, mean PASI score was 20.3 6 7.99; 27.5% (n ¼ 111) patientssuffered from PsA. At week 12, PASI 75 responses were statistically higher in earlyand monthly induction regimens versus placebo (54.5% and 42.0% vs 1.5%; P\.001for both) in overall population. PASI 75 responses in psoriasis patients with andwithout PsA were higher in early and monthly induction regimens versus placebo(50.0% and 44.4% vs 0% for psoriasis patients with PsA and 56.4% and 40.9% vs 1.9%for psoriasis patients without PsA). Serious adverse events and adverse event rates(including infections) were comparable among all treatment arms during inductionperiod.
Conclusion: Clinically relevant improvement in subjects with moderate to severeplaque psoriasis was seen in patients with and without PsA.
y was sponsored by Novartis Pharma AG, Basel, Switzerland.
This studJ AM ACAD DERMATOL
P6395Secukinumab reduces C-reactive protein levels in patients with moderateto severe plaque psoriasis: Result of a regimen-finding study
Bruce Strober, University of Connecticut School of Medicine, Farmington, CT,United States; Achim Guettner, Novartis Pharma AG, Basel, Switzerland; BardurSigurgeirrson, University of Iceland, Reykjavik, Iceland; Charis Papavassilis,Novartis Pharma AG, Basel, Switzerland
Background: Patients with psoriasis have high CRP levels, an inflammatorybiomarker which indicates cardiovascular risk. Here we evaluated the effect ofsecukinumab, a fully human antieinterleukin-17A monoclonal antibody, on CRPlevels in patients with moderate to severe plaque psoriasis. Efficacy and safetyresults of this study have been presented.
Methods: 404 patients were randomized (1:2:2:1) to receive subcutaneous admin-istration of either placebo (n ¼ 67) or 1 of the 3 secukinumab 150-mg inductionregimens: single (at week 0; n¼ 66), early (at weeks 0, 1, 2, 4; n¼ 133), andmonthly(at weeks 0, 4, 8; n¼ 138). The primary efficacy endpoint was the PASI 75 responseat week 12. Inflammatory marker high sensitivity (hs) CRP was assessed asexploratory post-hoc analysis at week 0 and week 12.
Results: At week 12, the median CRP levels reduced from 3.70 to 2.50 mg/L in themonthly regimen (P ¼ .026 vs placebo). Numerically greater reduction in medianCRP levels was observed in the early regimen (3.00 to 2.00 mg/L, P ¼ .124 vsplacebo). No significant change was observed in the single regimen (2.60 to 2.80mg/L; P ¼ .773 vs placebo) and placebo (3.00 to 3.05 mg/L).
Conclusion: In this study, some doses of secukinumab led to more pronouncedreductions in the CRP levels versus placebo, an indication that the inflammatoryburden in patients with moderate to severe plaque psoriasis may be lowered duringtherapy.
y was sponsored by Novartis Pharma AG, Basel, Switzerland.
This studP6871Secukinumab treatment shows a neutral effect on the lipid profile ofpatients with moderate to severe plaque psoriasis: Results from a ran-domized, double-blind, placebo-controlled, phase II study
Ulrich Mrowietz, Universit€atsklinikum Schleswig-Holstein, Kiel, Germany; AbrarQureshi, Harvard Medical School Brigham and Women’s Hospital, Boston, MA,United States; Cesar Escrig, Novartis Pharma AG, Basel, Switzerland; HannoRichards, Novartis Pharma AG, Basel, Switzerland; Helen Thurston, NovartisPharma AG, Basel, Switzerland
Background: Plaque psoriasis is a chronic, relapsing, systemic immune-mediateddisease associated with increased interleukin (IL)-17A levels. Secukinumab, a fullyhuman antieIL-17A monoclonal antibody, has shown efficacy in the treatment ofpsoriasis. Herein, we report the effect of secukinumab on the lipid profile of patientswith moderate to severe plaque psoriasis.
Methods: In this phase II, double-blind, placebo-controlled trial, patients (N ¼ 125)with moderate to severe plaque psoriasis were randomized (1:1:1:1:1) to receivemonthly subcutaneous doses of either placebo (n¼ 22) or secukinumab (13 25 mg[n¼ 29], 33 25 mg [n¼ 26], 33 75 mg [n¼ 21], 33 150 mg [n¼ 27]) at weeks 0,4, and 8; results of the 25-mg groups are not shown in this abstract. After 12weeks oftreatment, patients entered a follow-up period of 24 weeks. Secondary endpointsassessment included change in the lipid parameters (total cholesterol [TC], high-density lipoprotein cholesterol [HDLc], low-DLc [LDLc], and triglycerides [TG])from baseline to week 36.
Results: Demographics and baseline characteristics including body weight and lipidparameters were comparable across all treatment arms. Following 12 weeks oftherapy, there was no effect of secukinumab on the lipid profile of patientscompared with placebo and this was maintained throughout the study period (0-36weeks). Mean change 6 SD (mmol/L) for secukinumab 33 75 mg and 33 150 mggroups from baseline to week 36 in TC (-0.0066 0.66, 0.2396 0.69), HDLc (-0.0076 0.22, 0.120 6 0.16), LDLc (0.070 6 0.53, 0.149 6 0.57), and TG (-0.160 6 0.57,-0.227 6 1.22) showed no change compared with placebo (0.102 6 0.62, 0.091 60.32, 0.025 6 0.44, -0.025 6 0.74). Out of 5 SAEs, 3 cardiac SAEs (1 in 3 3 75 mgarm; 2 in placebo arm) and 1 death due tomyocardial infarction in the placebo groupwere reported during week 0-36.
Conclusion: In this study, secukinumab treatment was associated with a neutral lipidprofile and appeared not to be associated with any changes in the TC, HDLc, LDLc,and TG lipid profile of patients with moderate to severe plaque psoriasis.
y was sponsored by Novartis Pharma AG, Basel, Switzerland.
This studAPRIL 2013
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