Ixekizumab treatment improves fingernail psoriasis in patients with moderate‐to‐severe psoriasis: results from the randomized, controlled and open‐label phases of <scp>UNCOVER</scp>‐3

Nail psoriasis (PsO) is a disorder with profound impact on patients’ quality of life. Several challenges and unmet needs remain in the treatment of nail PsO. Introduction of biologics and small molecules in the treatment of nail PsO has allowed for rapid control of the disease and high efficacy. The aim of this review was to present the published studies on nail PsO therapy with biologics and small molecules and illuminate the results in the studies where the design and outcome evaluation had nail PsO in the forefront.

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“…At week 12, ixekizumab patients presented great improvement. By week 60, more than half the patients achieved complete resolution [53].…”

Section: Ixekizumabmentioning

confidence: 98%

Small Molecules and Biologics in the Treatment of Nail Psoriasis

Rigopoulos

Stathopoulou

Gregoriou³

2020

Skin Appendage Disord

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“…Furthermore, its efficacy has been confirmed also in difficult-to-treat areas (ie, scalp and nails)44–46 and severe clinical variants of psoriasis (ie, erythrodemic psoriasis) 41–43,45. Besides, ixekizumab has shown significant improvements in the activity of skin disease and in inhibiting radiographic progression in patients with concomitant iarthritis 46…”

Section: Introductionmentioning

confidence: 96%

“…In week 12, ixekizumab Q2W or Q4W resulted in a greater improvement in nail psoriasis than placebo or etanercept, as measured by NAPSI reduction percentage (ixekizumab Q2W 39% improvement, ixekizumab Q4W 40%, etanercept 28%, placebo −4.7%). In week 24, a lot more patients receiving ixekizumab showed no signs of nail involvement (34% and 30% in ixekizumab Q2W for 12 weeks then Q4W and ixekizumab Q4W, respectively) 42,43…”

Section: Introductionmentioning

confidence: 99%

Spotlight on ixekizumab for the treatment of moderate-to-severe plaque psoriasis: design, development, and use in therapy

Giunta¹,

Ventura²,

Chimenti

et al. 2017

DDDT

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Psoriasis is a chronic inflammatory disease affecting up to 3% of the general population, associated with discomfort and impaired quality of life. In recent years, the pathogenic cytokine network of psoriasis has been extensively studied leading to the development of new treatments that provide greater efficacy. Interleukin 17A (IL-17A) has been recognized as a crucial cytokine that mediates immunopathogenesis of psoriasis. Ixekizumab – indicated for the treatment of adults with moderate-to-severe plaque psoriasis – is a subcutaneously administered humanized monoclonal antibody that targets IL-17A. A large percentage of patients affected by psoriasis achieved consistent benefits in terms of disease control and rapid onset of action during clinical trials. Overall, ixekizumab brought clinical improvement and a favorable safety profile in phase III trials. Ixekizumab is characterized by consistent efficacy and rapid onset of response; it is not influenced by previous exposure to biologics and has shown good results in areas that are difficult to treat and in severe clinical variants of psoriasis. Ixekizumab has shown significant improvements in the activity of the disease and in those physical functions that inhibit radiographic progression in patients with concomitant involvement of joints. Our data support ixekizumab as a successful therapeutic option for patients affected by moderate-to-severe plaque-type psoriasis.

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“…Several clinical trials have evaluated long-term treatment and effectiveness of biologic agents for nail psoriasis. Most have evaluated subpopulations of psoriasis patients who had concomitant moderate-to-severe nail psoriasis [tumour necrosis factor alpha (TNF-a) inhibitors etanercept 15 and infliximab 16,17 ; IL 12/23 inhibitor ustekinumab, 18 IL-17A inhibitor ixekizumab 19,20 and JAK inhibitor tofacitinib 21 ]; however, none evaluated long-term safety in their respective nail psoriasis populations. Two trials prospectively evaluated patients with moderate-to-severe nail disease: one in patients treated with secukinumab 22,23 and the other in the current phase-3 trial described below.…”

Section: Introductionmentioning

confidence: 99%

Adalimumab for nail psoriasis: efficacy and safety over 52 weeks from a phase‐3, randomized, placebo‐controlled trial

Elewski

Baker

Crowley

et al. 2019

Acad Dermatol Venereol

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BackgroundFew clinical trials have evaluated long‐term treatment of nail psoriasis with biologics.ObjectiveSafety and efficacy of adalimumab [ADA; Humira AbbVie Inc, North Chicago, IL, USA)] long‐term treatment (52 weeks) was evaluated in a phase‐3, randomized trial in patients with moderate‐to‐severe plaque psoriasis and concomitant moderate‐to‐severe fingernail psoriasis. Results from the first 26 weeks (Period A) have been reported.MethodsPatients receiving 40 mg ADA every other week or placebo in Period A, continued with or switched to 40 mg ADA every‐other‐week treatment in the subsequent 26‐week open‐label extension (OLE) period. Main efficacy evaluations were ≥75% improvement in total‐fingernail modified Nail Psoriasis Severity Index (mNAPSI 75) and achievement of Physician's Global Assessment for Fingernail Psoriasis of clear or minimal disease (PGA‐F 0/1) with a ≥2‐grade improvement from baseline, across the trial for patients who continued ADA from Period A through the OLE (Continuous‐ADA Population). Safety was evaluated during the OLE and for patients receiving ADA at any time during the study (All‐ADA Population).ResultsOf the 217 patients initially randomized in Period A, 188 (86.6%; 94 in each treatment group) entered the OLE after completion of or early escape from Period A. For the Continuous‐ADA Population (N = 109), endpoint achievement rates improved from OLE entry (Week 26) to Week 52, including total‐fingernail mNAPSI 75 (47.4–54.5%); PGA‐F 0/1 (51.1–55.6%) and total‐fingernail mNAPSI = 0 (6.6–17.9%). Serious adverse event and serious infection rates for the All‐ADA Population (N = 203) were 6.9% and 3.4%, respectively.ConclusionsIn this population of psoriasis patients with concomitant, moderate‐to‐severe nail psoriasis, long‐term efficacy and improvement in signs and symptoms of nail disease were demonstrated after every‐other‐week ADA treatment, including incremental improvements in rate of total clearance of nail disease. No new safety risks were identified for patients receiving at least one ADA dose across 52 weeks.

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Ixekizumab treatment improves fingernail psoriasis in patients with moderate‐to‐severe psoriasis: results from the randomized, controlled and open‐label phases of UNCOVER‐3

Abstract: At Week 12, significant improvements in fingernail psoriasis were achieved with ixekizumab therapy. With IXE Q4W maintenance dosing, additional improvement was demonstrated through 60 weeks, and >50% of patients achieved complete resolution. Registered at clinicaltrials.gov: NCT01646177.

Cited by 77 publications

References 17 publications

Small Molecules and Biologics in the Treatment of Nail Psoriasis

Small Molecules and Biologics in the Treatment of Nail Psoriasis

Spotlight on ixekizumab for the treatment of moderate-to-severe plaque psoriasis: design, development, and use in therapy

Adalimumab for nail psoriasis: efficacy and safety over 52 weeks from a phase‐3, randomized, placebo‐controlled trial

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