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The efficacy and safety of apremilast, etanercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled trial (LIBERATE).

ABSTRACT: Apremilast, an oral, small-molecule phosphodiesterase 4 inhibitor, has demonstrated efficacy in patients with moderate-to-severe psoriasis.Evaluate efficacy and safety of apremilast vs. placebo in biologic-naive patients with moderate-to-severe plaque psoriasis and safety of switching from etanercept to apremilast in a phase IIIb, randomized, double-blind, placebo-controlled study (NCT01690299).Two hundred and fifty patients were randomized to placebo (n = 84), apremilast 30 mg BID (n = 83) or etanercept 50 mg QW (n = 83) through Week 16; thereafter, all patients continued or switched to apremilast through Week 104. The primary efficacy endpoint was achievement of PASI-75 at Week 16 with apremilast vs. placebo. Secondary endpoints included achievement of PASI-75 at Week 16 with etanercept vs. placebo and improvements in other clinical endpoints vs. placebo at Week 16. Outcomes were assessed through Week 52. This study was not designed for apremilast vs. etanercept comparisons.At Week 16, PASI-75 achievement was greater with apremilast (39.8%) vs. placebo (11.9%; P < 0.0001); 48.2% of patients achieved PASI-75 with etanercept (P < 0.0001 vs. placebo). PASI-75 response was maintained in 47.3% (apremilast/apremilast), 49.4% (etanercept/apremilast) and 47.9% (placebo/apremilast) of patients at Week 52. Most common adverse events (?5%) with apremilast, including nausea, diarrhoea, upper respiratory tract infection, nasopharyngitis, tension headache and headache, were mild or moderate in severity; diarrhoea and nausea generally resolved in the first month. No new safety or tolerability issues were observed through Week 52 with apremilast.Apremilast demonstrated significant efficacy vs. placebo at Week 16 in biologic-naive patients with psoriasis, which was sustained over 52 weeks, and demonstrated safety consistent with the known safety profile of apremilast. Switching from etanercept to apremilast did not result in any new or clinically significant safety findings, and efficacy was maintained with apremilast through Week 52.

SUBMITTER: Reich K

PROVIDER: S-EPMC5363370 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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The efficacy and safety of apremilast, etanercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled trial (LIBERATE).

Reich K K Gooderham M M Green L L Bewley A A Zhang Z Z Khanskaya I I Day R M RM Goncalves J J Shah K K Piguet V V Soung J J

Journal of the European Academy of Dermatology and Venereology : JEADV 20161219 3

<h4>Background</h4>Apremilast, an oral, small-molecule phosphodiesterase 4 inhibitor, has demonstrated efficacy in patients with moderate-to-severe psoriasis.<h4>Objective</h4>Evaluate efficacy and safety of apremilast vs. placebo in biologic-naive patients with moderate-to-severe plaque psoriasis and safety of switching from etanercept to apremilast in a phase IIIb, randomized, double-blind, placebo-controlled study (NCT01690299).<h4>Methods</h4>Two hundred and fifty patients were randomized to ...[more]

PMID: 27768242

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Project description:IntroductionCertolizumab pegol (CZP), an Fc-free, PEGylated anti-tumour necrosis factor biologic, dosed at 400 mg every 2 weeks (Q2W) and 200 mg Q2W over 16 weeks, resulted in improvements in Japanese patients with moderate to severe plaque psoriasis (PSO); no new safety signals were identified. We present 52-week efficacy and safety results.MethodsPatients ≥ 20 years with PSO ≥ 6 months [Psoriasis Area and Severity Index (PASI) ≥ 12, body surface area ≥ 10%, Physician's Global Assessment (PGA) ≥ 3] were randomised 1:2:2 to placebo Q2W, CZP 400 mg Q2W and CZP 200 mg Q2W (400 mg weeks 0/2/4) for 16 weeks. Week 16 PASI 50 responders continued through week 52; CZP 200 mg Q2W-randomised patients were re-randomised 1:1 to CZP 200 mg Q2W or CZP 400 mg Q4W; patients initially randomised to other treatment groups continued in the same group. Outcomes included PASI 75/90/100, PGA 0/1, Dermatology Life Quality Index (DLQI) 0/1, Itch Numeric Rating Scale (INRS) 0, modified Nail Psoriasis Severity Index (mNAPSI), durability of response for week 16 PASI 75/90 responders, and safety.ResultsOf 26/53/48 patients randomised to placebo, CZP 400 mg Q2W and CZP 200 mg Q2W, 2/47/39 completed week 52, respectively. PASI 75/90 responses were generally maintained from weeks 16 to 52 for all CZP doses. Most week 16 PASI 75/90 achievers maintained their response through week 52. PASI 75/90/100 responses at week 52 in the CZP 400 mg Q2W and CZP 200 mg Q2W groups were 83.0/81.1/41.5% and 72.9/60.4/18.8%, respectively; DLQI/INRS remission rates were 64.2/50.9% in CZP 400 mg Q2W and 58.3/27.1% in CZP 200 mg Q2W-treated patients. Reductions in mNAPSI observed for CZP-treated groups were maintained through week 52. No new safety signals were identified.ConclusionCZP treatment resulted in improvements in signs and symptoms of PSO, which were maintained through week 52. The 400 mg Q2W dose could provide additional clinical benefit.Trial registrationNCT03051217.

Project description:BackgroundThe efficacy and safety of biologic treatments for children and adolescents with moderate to severe psoriasis should be examined over a considerable time period and in different subgroups.ObjectiveWe report the efficacy and safety of secukinumab low dose (LD) and high dose (HD) regimens in pediatric patients with moderate to severe psoriasis for up to Week 52.MethodsThis was a randomized, open-label, parallel-group, multicenter study in patients aged 6 to < 18 years. Patients were randomized in a 1:1 ratio to receive LD (75/75/150 mg; N = 42) or HD (75/150/300 mg; N = 42) subcutaneous secukinumab. At randomization, patients were stratified by weight (< 25, 25 to < 50, ≥ 50 kg) and disease severity (moderate/severe). The study is ongoing; the present analysis included data up to Week 52 collected from August 29, 2018 (first patient first visit) to May 28, 2020 (last patient last visit for Week 52). Efficacy was measured using Investigator's Global Assessment modified 2011 0/1 (IGA 0/1) and Psoriasis Area Severity Index (PASI) 75/90/100 response. Safety outcomes included assessment of adverse events.ResultsOf the 84 enrolled patients, 78 (92.9%) completed 52 weeks of treatment. Overall, response rates for PASI 75 and IGA 0/1 were similar between the LD (92.8/88.9%) and HD (93.3/84.7%) groups at Week 52. In the LD and HD groups, PASI 90/100 responses at Week 52 were 78.7/53.5% and 84.7/70.0%, respectively. The proportions of IGA 0/1 and PASI 75/90 responders were comparable for the age, body weight, and disease severity subgroups in the secukinumab LD and HD groups. Mean absolute PASI change from baseline at week 52 was - 17.3 ± standard deviation 5.0 and - 18.2 ± 7.0, a percentage change of - 94.3 and - 94.5% for the LD and HD groups, respectively. More than 70% of evaluable patients achieved Children's Dermatology Life Quality Index 0/1 at Week 52 (LD 70.7%; HD 70.3%). The safety profile was consistent with that in adults, with no new safety signals for either secukinumab dosing regimen.ConclusionA high proportion of pediatric patients with psoriasis responded to both dosing regimens of secukinumab and maintained clinical responses through 52 weeks of treatment. No clinical difference was observed in the efficacy of secukinumab across the pediatric subgroups. Safety events were consistent with the established safety profile of secukinumab.Trial registrationClinicalTrials.gov: NCT03668613.

Project description:IntroductionAlthough dimethyl fumarate (DMF) has been approved since 2017 for treatment of moderate-to-severe plaque psoriasis, limited data on its safety and efficacy are available in clinical practice. The objective was to assess the efficacy and safety of DMF in patients with moderate-to-severe plaque psoriasis through 52 weeks in conditions close to real clinical practice.MethodsDIMESKIN 1 was a 52-week, open-label, phase IV clinical trial conducted at 36 Spanish sites. Adults with diagnosis of moderate-to-severe plaque psoriasis, treated with DMF as per its summary of product characteristics and with ≥ 1 post-baseline Psoriasis Area and Severity Index (PASI) value were included [intention-to-treat (ITT) population]. Efficacy analyses were performed for ITT population and are based on multiple imputation.ResultsOverall, 282 and 274 patients were included in the safety and ITT populations, respectively. At week 24, 46.0%/24.8%/10.9% of patients achieved PASI 75/90/100 response, respectively. At week 52, these percentages were 46.0%/21.9%/10.9%, respectively. Mean body surface area affected decreased from 17.4% to 6.9%/7.3% after 24/52 weeks (p < 0.001, both). A total of 42.9%/49.4% of patients had a Physician's Global Assessment 0-1 at week 24/52, respectively. Mean pruritus visual analogue scale (VAS) significantly decreased after 24 and 52 weeks (p < 0.001, both), with 56.5% and 67.6% of patients, respectively, rating a pruritus VAS < 3. At week 24/52, 61.3%/73.4% patients had a Dermatology Life Quality Index (DLQI) ≤ 5 and 34.7%/32.1% had a DLQI 0-1. The most frequent adverse events were gastrointestinal disorders (mainly diarrhea/abdominal pain in 50.0%/35.1% of patients, respectively), flushing (28.0%), and lymphopenia (31.2%), mostly mild/moderate.ConclusionsDMF significantly improves main severity and extension indexes and rates, as well as patient-reported outcomes such as pruritus and quality of life in patients with moderate-to-severe psoriasis after 24 weeks of treatment. These improvements are sustained through 52 weeks. The safety profile of DMF is similar to that previously described for fumarates.Eudract number2017-00136840.

Dataset Information

The efficacy and safety of apremilast, etanercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled trial (LIBERATE).

Publications

The efficacy and safety of apremilast, etanercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled trial (LIBERATE).

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