Improvement of scalp and nail lesions with ixekizumab in a phase 2 trial in patients with chronic plaque psoriasis

Langley, Richard; Rich, Phoebe; Menter, Alan; Krueger, Gerald G.; Goldblum, Orin; Dutronc, Yves; Zhu, Baojin; Wei, Hong; Cameron, Greg; Heffernan, Michael

doi:10.1111/jdv.12996

Cited by 70 publications

(53 citation statements)

References 31 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…A modified NAPSI was used in 22% of studies with assessment on scales of 0–24 (degree of severity for nail matrix and nail bed features), 0–96 (degree of severity for each nail matrix and bed feature assessed separately in each quadrant), 0–14 (degree of severity for crumbling, onycholysis and pitting only) or on a scale that was not defined . A NAPSI of multiple nails was used in 20% of studies, with assessment of all fingernails and/or toenails, a single‐hand or all fingernails excluding the thumbnails . The majority of (mostly ongoing) studies (46%) did not adequately report the characteristics of NAPSI (to be) used.…”

Section: Resultsmentioning

confidence: 99%

Reporting of outcomes in randomized controlled trials on nail psoriasis: a systematic review

et al. 2018

View full text Add to dashboard Cite

show abstract

Section: Resultsmentioning

confidence: 99%

Reporting of outcomes in randomized controlled trials on nail psoriasis: a systematic review

et al. 2018

View full text Add to dashboard Cite

show abstract

“…The efficacy findings for patients with plaque psoriasis, including PASI, sPGA, percentage BSA, NAPSI, PSSI, DLQI and Itch NRS, were consistent with 12-week phase 3 studies, 5 the short-term results in Japanese patients, 6 the long-term, 52-week global study, 4 and a post-hoc analysis of scalp and nail psoriasis from a phase 2 psoriasis study. 13 In mostly Caucasian patients, ixekizumab treatment for 52 weeks resulted in 77% of patients with a PASI 75 at the 52-week end-point. 4 In our study in Japanese patients, ixekizumab treatment for 52 weeks resulted in 92.3% of patients with a PASI 75 at the 52-week end-point.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of ixekizumab treatment for Japanese patients with moderate to severe plaque psoriasis, erythrodermic psoriasis and generalized pustular psoriasis: Results from a 52‐week, open‐label, phase 3 study (UNCOVER‐J)

Saeki

Nakagawa

Nakajo

et al. 2016

The Journal of Dermatology

177

186

View full text Add to dashboard Cite

Psoriasis, a chronic, immune‐mediated skin disease characterized by red, scaly plaques, affects approximately 0.3% of the population in Japan. The aim of this open‐label study was to evaluate the long‐term efficacy and safety of ixekizumab, a humanized, anti‐interleukin‐17A monoclonal antibody, in Japanese patients with plaque psoriasis (n = 78, including 11 psoriatic arthritis), erythrodermic psoriasis (n = 8) and generalized pustular psoriasis (n = 5). Ixekizumab was administrated s.c. at baseline (week 0, 160 mg), from weeks 2 to 12 (80 mg every 2 weeks), and from weeks 16 to 52 (80 mg every 4 weeks). At week 52, 92.3% of patients with plaque psoriasis achieved Psoriasis Area and Severity Index (PASI) 75, 80.8% achieved PASI 90, 48.7% achieved PASI 100, and 52.6% had remission of plaques (by static Physician Global Assessment, sPGA [0]). Difficult to treat areas of psoriasis (nail or scalp) also responded to ixekizumab. All patients with psoriatic arthritis who were assessed (5/5) achieved an American College of Rheumatology 20 response. Most patients with erythrodermic psoriasis or generalized pustular psoriasis responded to ixekizumab and the clinical outcome was maintained over 52 weeks (75% and 60% of patients achieved sPGA [0, 1] at week 52, respectively). Mostly mild or moderate treatment‐emergent adverse events were reported by 79 of 91 patients; the most common were nasopharyngitis, eczema, seborrheic dermatitis, urticaria and injection site reactions. In conclusion, 52‐week ixekizumab treatment was efficacious and well tolerated in Japanese patients with plaque psoriasis. Efficacy was also observed in patients with erythrodermic psoriasis, generalized pustular psoriasis and psoriatic arthritis.

show abstract

“…Papp et al, 15 Lebwohl et al, 16 Papp et al, 28 Nakagawa et al, 29 Papp et al, 30 Mease et al 31 Ixekizumab Leonardi et al, 32 Gordon et al, 34 Saeki et al, 35 Langley et al, 36 Griffiths et al, 45 Yamasaki et al 46 Etanercept 1065 4 (0Á4)…”

Section: Incidence Of Candida Infection During Secukinumab Treatmentmentioning

confidence: 99%

“…33 Four of the selected ixekizumab studies reported no incidences of Candida infection over their duration (Table 2). 32,[34][35][36]…”

Section: Treatment With Brodalumab and The Prevalence Of Candida Infementioning

confidence: 99%

Candida infections in patients with psoriasis and psoriatic arthritis treated with interleukin-17 inhibitors and their practical management

et al. 2017

View full text Add to dashboard Cite

The recognition of the central role of interleukin (IL)-17A in the pathogenesis of psoriasis has led to the development of several monoclonal antibodies targeting this cytokine or its receptors for therapeutic purposes. IL-17A also plays an important role in immunological protection against infections, especially those due to Candida spp., as evidenced by findings in patients with genetic defects in IL-17-related immune responses. To assess the potential of anti-IL-17 treatment to promote Candida infections, here we have systematically reviewed published clinical trials of patients with psoriasis or psoriatic arthritis. Candida infections were reported in 4·0% of patients treated with brodalumab, 1·7% with secukinumab and 3·3% with ixekizumab vs. 0·3%, 2·3% and 0·8% of those assigned to placebo, ustekinumab or etanercept, respectively. Although the incidence of Candida infection was found to be increased by only a small degree during anti-IL-17 therapy, patients undergoing such treatment should be monitored for fungal infection and treated as necessary. We propose adoption of the recently updated recommendations for the practical management of Candida infection in patients administered IL-17 inhibitors.

show abstract

Improvement of scalp and nail lesions with ixekizumab in a phase 2 trial in patients with chronic plaque psoriasis

Abstract: Ixekizumab monotherapy improved scalp psoriasis quickly with maintenance of clinical response and complete resolution of plaques in the majority of patients. Additionally, over 50.0% of patients with nail psoriasis experienced complete resolution of nail lesions by OLE week 48.

Cited by 70 publications

References 31 publications

Reporting of outcomes in randomized controlled trials on nail psoriasis: a systematic review

Reporting of outcomes in randomized controlled trials on nail psoriasis: a systematic review

Efficacy and safety of ixekizumab treatment for Japanese patients with moderate to severe plaque psoriasis, erythrodermic psoriasis and generalized pustular psoriasis: Results from a 52‐week, open‐label, phase 3 study (UNCOVER‐J)

Candida infections in patients with psoriasis and psoriatic arthritis treated with interleukin-17 inhibitors and their practical management

Contact Info

Product

Resources

About