Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator–controlled VOYAGE 1 trial

Blauvelt, Andrew; Papp, Kim; Griffiths, C.E.M.; Randazzo, B.; Wasfi, Y.; Shen, Yaung‐Kaung; Li, Shu; Kimball, Alexa B.

doi:10.1016/j.jaad.2016.11.041

Cited by 727 publications

(918 citation statements)

References 39 publications

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“…77, 78 Both VOYAGE trials were 48-week studies that compared guselkumab to placebo and adalimumab, though the VOYAGE 2 trial also evaluated the clinical response in psoriasis patients with interrupted treatment (randomized withdrawal and retreatment). Results from the VOYAGE 1 and 2 trials were highly similar and reported a PASI90 response in 73% and 70% of patients, respectively, at week 16 compared to approximately 50% of patients treated with adalimumab.…”

Section: Recently Approved and Novel Therapeutic Agents For Psoriasismentioning

confidence: 99%

Psoriasis pathogenesis and the development of novel targeted immune therapies

Hawkes

Chan

Krueger

2017

Journal of Allergy and Clinical Immunology

740

605

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Psoriasis is caused by a complex interplay between the immune system, psoriasis-associated susceptibility loci, psoriasis autoantigens, and multiple environmental factors. Over the last two decades, research has unequivocally shown that psoriasis represents a bona fide T-cell mediated disease primarily driven by pathogenic T-cells that produce high levels of IL-17 in response to IL-23. The discovery of the central role for the IL-23/T17 cell axis in the development of psoriasis has led to a major paradigm shift in the pathogenic model for this condition. The activation and upregulation of IL-17 in pre-psoriatic skin produces a “feed forward” inflammatory response in keratinocytes that is self-amplifying and drives the development of mature psoriatic plaques by inducing epidermal hyperplasia, epidermal cell proliferation, and the recruitment of leukocyte subsets into the skin. Clinical trial data for monoclonal antibodies against IL-17 signaling (secukinumab, ixekizumab, and brodalumab) and newer IL-23p19 antagonists (tildrakizumab, guselkumab, and risankizumab) underscore the central role of these cytokines as predominant drivers of psoriatic disease. We are currently witnessing a translational revolution in the treatment and management of psoriasis. Emerging bispecific antibodies offer the potential for even better disease control, while small molecule drugs may offer future alternatives to the use of biologics and less costly long-term disease management.

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Section: Recently Approved and Novel Therapeutic Agents For Psoriasismentioning

confidence: 99%

Psoriasis pathogenesis and the development of novel targeted immune therapies

Hawkes

Chan

Krueger

2017

Journal of Allergy and Clinical Immunology

740

605

View full text Add to dashboard Cite

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“…For example, both IL-17A blockade with ixekizumab9 and IL-23 blockade with guselkumab36 are superior to TNF-α blockade (with etanercept and adalimumab, respectively). In other trials, IL-17A blockade with secukinumab,34 IL-17R blockade with brodalumab37 and IL-23p19 blockade with risankizumab38 all appear superior to IL-12/23p40 blockade with ustekinumab.…”

Section: The Th17 Axismentioning

confidence: 99%

Novel therapies for immune-mediated inflammatory diseases: What can we learn from their use in rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus, psoriasis, Crohn’s disease and ulcerative colitis?

2017

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The past three decades have witnessed remarkable advances in our ability to target specific elements of the immune and inflammatory response, fuelled by advances in both biotechnology and disease knowledge. As well as providing superior treatments for immune-mediated inflammatory diseases (IMIDs), such therapies also offer unrivalled opportunities to study the underlying immunopathological basis of these conditions.In this review, we explore recent approaches to the treatment of IMIDs and the insights to pathobiology that they provide. We review novel biologic agents targeting the T-helper 17 axis, including therapies directed towards interleukin (IL)-17 (secukinumab, ixekizumab, bimekizumab), IL-17R (brodalumab), IL-12/23p40 (ustekinumab, briakinumab) and IL-23p19 (guselkumab, tildrakizumab, brazikumab, risankizumab, mirikizumab). We also present an overview of biologics active against type I and II interferons, including sifalumumab, rontalizumab, anifrolumab and fontolizumab. Emerging strategies to interfere with cellular adhesion processes involved in lymphocyte recruitment are discussed, including both integrin blockade (natalizumab, vedolizumab, etrolizumab) and sphingosine-1-phosphate receptor inhibition (fingolimod, ozanimod). We summarise the development and recent application of Janus kinase (JAK) inhibitors in the treatment of IMIDs, including first-generation pan-JAK inhibitors (tofacitinib, baricitinib, ruxolitinib, peficitinib) and second-generation selective JAK inhibitors (decernotinib, filgotinib, upadacitinib). New biologics targeting B-cells (including ocrelizumab, veltuzumab, tabalumab and atacicept) and the development of novel strategies for regulatory T-cell modulation (including low-dose IL-2 therapy and Tregitopes) are also discussed. Finally, we explore recent biotechnological advances such as the development of bispecific antibodies (ABT-122, COVA322), and their application to the treatment of IMIDs.

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“…The efficacy and safety of guselkumab were confirmed in three phase III trials in psoriasis: VOYAGE 1, VOYAGE 2 and NAVIGATE 14, 15, 16. Limited PSSD results from these studies have been reported previously.…”

Section: Introductionmentioning

confidence: 59%

“…3). 14 Greater proportions of patients in the guselkumab group achieved a score of 0 on each of the individual item scales for both the symptom and sign summary scores compared with placebo at week 16 (all P < 0.001) (Table 3). Similarly, greater proportions of patients in the guselkumab group achieved a score of 0 on each individual item scale for both symptoms and signs compared with adalimumab at weeks 24 and 48 (all P < 0.01) (Table 3).…”

Section: Resultsmentioning

confidence: 96%

Patient‐reported symptoms and signs of moderate‐to‐severe psoriasis treated with guselkumab or adalimumab: results from the randomized VOYAGE 1 trial

Papp

Blauvelt

Kimball

et al. 2018

Acad Dermatol Venereol

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BackgroundHow patients experience the symptoms/signs of psoriasis is highly relevant for assessing treatment response.ObjectivesCompare outcomes with guselkumab, placebo and adalimumab utilizing the novel, validated Psoriasis Symptoms and Signs Diary (PSSD).Methods VOYAGE 1 is an ongoing, phase III, double‐blinded, controlled trial of patients with moderate‐to‐severe psoriasis. Patients were randomized to guselkumab 100 mg every 8 weeks; placebo‐to‐guselkumab 100 mg every 8 weeks; or adalimumab 40 mg every 2 weeks. The PSSD was self‐administered to assess symptoms (i.e. itch, skin tightness, burning, stinging and pain) and signs (i.e. dryness, cracking, scaling, shedding/flaking, redness and bleeding) of psoriasis (0–10 [absent‐to‐worst‐imaginable]) every 24 h. Symptom and sign summary scores were derived (0–100) based on average scores of the individual symptoms and signs. Proportions of patients with clinically meaningful improvements and symptom‐ and sign‐free scores of 0 were evaluated across treatment groups at weeks 16, 24 and 48.ResultsAt baseline, 652 of 837 randomized patients had PSSD scores. The proportion of patients achieving clinically meaningful improvements in PSSD summary scores was significantly higher in the guselkumab group compared with the placebo group at week 16 (P < 0.001) and compared with the adalimumab group at weeks 24 (P = 0.002) and 48 (P < 0.001). The proportions of patients achieving PSSD symptom and sign summary scores of 0 (i.e. symptom‐ and sign‐free) were significantly higher for guselkumab vs. placebo at week 16 and vs. adalimumab at weeks 24 and 48 (all P < 0.001).ConclusionsBased on PSSD scores, greater improvements in symptoms and signs of psoriasis were reported by patients treated with guselkumab compared with placebo at week 16 or adalimumab through 48 weeks.

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Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator–controlled VOYAGE 1 trial

Abstract: Guselkumab demonstrated superior efficacy compared with adalimumab and was well tolerated in patients with psoriasis through 1 year.

Cited by 727 publications

References 39 publications

Psoriasis pathogenesis and the development of novel targeted immune therapies

Psoriasis pathogenesis and the development of novel targeted immune therapies

Novel therapies for immune-mediated inflammatory diseases: What can we learn from their use in rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus, psoriasis, Crohn’s disease and ulcerative colitis?

Patient‐reported symptoms and signs of moderate‐to‐severe psoriasis treated with guselkumab or adalimumab: results from the randomized VOYAGE 1 trial

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