Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial

Nash, Peter; Kirkham, Bruce; Okada, Masato; Rahman, Proton; Combe, B.; Burmester, Gerd R.; Adams, David H.; Kerr, Lisa; Lee, Chin; Shuler, Catherine L; Genovese, Mark C.; Ahmed, Khalid; Alper, Jeffrey; Barkham, N.; Bennett, Ralph E.; Garcı́a, Francisco; Alonso, Ricardo Blanco; Blumstein, Howard B.; Brooks, M. S. S.; Cagnoli, Patricia; Caldron, Paul H.; Cantagrel, Alain; Chen, Der Yuan; Churchill, Melvin; Codding, C.; Deane, Peter M. G.; Giudice, José Del; Deodhar, Atul; Dhar, Rajat K.; Dokoupilová, Eva; Egan, Rita M.; Everding, Andrea; Galíndez, E.; Goddard, David H.; Gottlieb, Alice B.; Goupille, Philippe; Griffin, Robert; Gupta, Ramesh C.; Hall, Stephen; Hatti, Kalpita; Howell, Mary P.; Huang, Yu Huei; Jajoo, Ramina; Janssen, Namieta M.; Kiltz, Uta; Kivitz, Alan; Klein, Steven J.; Korkosz, Mariusz; Kotha, Roshan; Kremer, Joel M.; Lue, Cummins; Fuente, José Luís Marenco de la; Marzo‐Ortega, Helena; Masmitjá, Jordi Gratacós; Mease, Philip J.; Meroni, Pier Luigi; Mueller, Eric C.; Nandagudi, Anupama; Fernández‐Nebro, Antonio; Neuwelt, C. Michael; Orbai, Ana‐Maria; Oza, Meera; Parks, Deborah L.; Pattanaik, Debendra; Rell‐Bakalarska, Maria; Rosmarin, David; Roussou, Euthalia; Rychlewska-Hanczewksa, Anna I.; Sikes, David; Stack, Michael T.; Sunkureddi, Prashanth; Tahir, Hasan; Thaçi, Diamant; Tsai, Tsen‐Fang; Turkiewicz, Anthony; Unger, L.; Cabello, Raúl Veiga; Wagner, U.; Wei, James Cheng‐Chung; Wells, Alvin F.; Youssef, Peter; Zielińska, Agnieszka

doi:10.1016/s0140-6736(17)31429-0

Cited by 334 publications

(296 citation statements)

References 26 publications

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“…Phase III trials assessing the clinical efficacy of ixekizumab (UNCOVER 1, UNCOVER 2, and UNCOVER 3) showed PASI 75 response in 80–90% of patients as compared to 10% and 40–50% in placebo and etanercept groups, respectively . Results of the psoriatic arthritis trials (SPIRIT‐P1, SPIRIT–P2) are comparable to FUTURE trials of secukinumab, with more than 50% of patients achieving ACR20 response at week 12 …”

Section: Systemic Agents For Psoriasismentioning

confidence: 90%

Review of safety and efficacy of approved systemic psoriasis therapies

Kaushik

Lebwohl

2018

Int J Dermatology

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Psoriasis is a chronic inflammatory disease which affects nearly 3% of the adult US population. Due to the chronic nature of the disease and need for long‐term treatment, psoriasis is associated with substantial disease burden and negative impact on patients’ quality of life. In the past, systemic agents such as methotrexate, cyclosporine, and acitretin have been the mainstay treatment for moderate to severe psoriasis. Multiple new molecular targets have been recently identified, and novel biologic therapies directed at these targets have been approved leading to a paradigm shift in psoriasis management. However, despite the availability of several treatment options and continued introduction of highly efficacious biologics, undertreatment of psoriasis patients remains a huge problem. This can be largely attributed to several causes including high cost of biologics, lack of experience, and reluctance of practitioners to initiate or switch to systemic treatment regimens in moderate to severe psoriasis patients. In this article, we aim to provide a concise review of mechanism, safety, and efficacy of the approved systemic treatments for psoriasis.

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Section: Systemic Agents For Psoriasismentioning

confidence: 90%

Review of safety and efficacy of approved systemic psoriasis therapies

Kaushik

Lebwohl

2018

Int J Dermatology

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“…Results of completed clinical studies confirmed the efficacy of the medicines based on IL‐17 inhibitors. The studies constitute the basis to draw a conclusion about continuously developing methods of psoriasis treatment which bring about satisfactory effects . The applied therapy improves the quality of patients’ lives, thus enabling them to operate in social life at the higher level.…”

Section: Discussionmentioning

confidence: 99%

“…Infections of various etiopathology were mentioned as the most frequent. In total, they appeared in 129 patients (after 47 patients in the group taking the medicine and 35 in the placebo group) (Table ) …”

Section: Introductionmentioning

confidence: 99%

Are new variants of psoriasis therapy (IL‐17 inhibitors) safe?

Wcisło‐Dziadecka

Kaźmierczak²,

Grabarek³

et al. 2019

Int J Dermatology

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Psoriasis is a chronic, recurrent, inflammatory, and proliferative skin disease. Its etiology has not yet been fully assessed, but undoubtedly it is a multifaceted disease. The key role in its pathomechanism is played by genetic, immunologic, and environmental factors and stress. If traditional methods of psoriasis treatment (phototherapy, methotrexate, retinoids, cyclosporine A) fail, we reach for the following biopharmaceuticals – infliximab, etanercept, adalimumab, or ustekinumab. However, genetic engineering progress discovers new possibilities – the pending clinical trials involve IL‐17, IL‐23 antagonists, PDE4 and ‐3 and ‐1. Psoriasis etiopathogenesis mainly involves the IL‐17A, IL‐17F, and IL‐17A/F subtypes, which affect the keratinocytes. The biological therapy molecularly oriented with the antagonists of interleukin 17 is based mainly on the influence onto the cytokine in the manner that prevents it from binding with the receptor. Three biopharmaceuticals are currently under third phase studies: two fully humanized antibodies neutralizing IL‐17 – ixekizumab and secukinumab, and one human monoclonal antibody, brodalumab. The below work will be devoted to the analysis of possible undesirable symptoms, which were observed during the studies. We will try to review the latest literature concerning the most important clinical trials conducted in many centers.

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“…Additionally, mice treatment with anti‐IL‐17a antibodies exhibited significantly reduced disease development . Ixekizumab is a fully humanized monoclonal antibody targeting IL‐17a which has been investigated as a potential treatment in multiple autoimmune conditions . A trial studying the effects of Ixekizumab on BP patients is currently in the recruitment stages (NCT03099538).…”

Section: Evolving Therapeutic Targetsmentioning

confidence: 99%

From bench to bedside: evolving therapeutic targets in autoimmune blistering disease

Kridin

Kowalski

Kneiber

et al. 2019

Acad Dermatol Venereol

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Autoimmune blistering diseases comprise a group of heterogenous conditions characterized by the loss of tolerance and subsequent development of autoantibodies targeting epidermal and subepidermal adhesion proteins. Blisters and erosions form on the skin and mucous membranes leading to significant morbidity and mortality. Traditional therapies rely on systemic immunosuppression. Advancements in our understanding of the pathophysiology of pemphigus and pemphigoid have led to the development of molecules which target specific pathways involved in induction and perpetuation of disease. In this review, we outline the novel therapeutic strategies including B‐cell depletion, T‐regulatory cell repletion, cell signalling inhibitors and small molecular inhibitors, inhibitory monoclonal antibodies, as well as complement inhibition. We additionally review their current level of clinical evidence. We lastly review therapeutics targets gleaned from the experimental epidermolysis bullosa acquisita mouse model. These emerging treatments offer an exciting progression from basic science discoveries that have the potential to transform the treatment paradigm in autoimmune blistering diseases.

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Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial

Cited by 334 publications

References 26 publications

Review of safety and efficacy of approved systemic psoriasis therapies

Review of safety and efficacy of approved systemic psoriasis therapies

Are new variants of psoriasis therapy (IL‐17 inhibitors) safe?

From bench to bedside: evolving therapeutic targets in autoimmune blistering disease

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