A Phase 2 Trial of Guselkumab versus Adalimumab for Plaque Psoriasis

Gordon, Kenneth B.; Duffin, Kristina Callis; Bissonnette, Robert; Prinz, Jörg C.; Wasfi, Y.; Li, Shu; Shen, Yaung Kaung; Szapary, Philippe; Randazzo, B.; Reich, Kristian

doi:10.1056/nejmoa1501646

Cited by 268 publications

(298 citation statements)

References 29 publications

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“…In all, 38 RCTs (identified in 38 reports)20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57 met the eligibility criteria and were included, as shown in Figure 1. These trials involved a total of 18 024 patients with plaque psoriasis.…”

Section: Resultsmentioning

confidence: 99%

“…Eighteen RCTs compared TNFi (four adalimumab,20, 21, 22, 23, 24 nine etanercept,26, 27, 28, 29, 30, 31, 32, 34, 35 five infliximab36, 37, 38, 39, 40) with placebo, with three studies reporting MACEs; four RCTs compared ustekinumab (anti‐IL‐12/23) with placebo46, 47, 48 with no MACEs reported. One RCT compared ixekizumab with placebo without MACEs reported 56, 57.…”

Section: Resultsmentioning

confidence: 99%

“…Patients in 27 RCTs20, 21, 22, 25, 27, 28, 29, 30, 31, 34, 35, 36, 37, 38, 39, 40, 43, 45, 46, 47, 48, 50, 52, 53, 57 did not experience MACEs while exposed to any interventions but 10 MACEs were observed during the randomized controlled phase of nine studies 23, 26, 32, 33, 42, 44, 49, 51. Overall, the pooled analysis of these nine trials found that there was no statistically significant difference in the risk of MACEs when comparing biologic therapies with placebo (pooled OR 1·45, 95% CI 0·34–6·24, P = 0·62), as shown in Figure 2a.…”

Section: Resultsmentioning

confidence: 99%

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Impact of biologic therapies on risk of major adverse cardiovascular events in patients with psoriasis: systematic review and meta-analysis of randomized controlled trials

et al. 2017

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SummaryConcerns have been raised regarding an increased risk of major adverse cardiovascular events (MACEs) (myocardial infarction, cerebrovascular accident or cardiovascular death) in patients treated with anti‐interleukin (IL)‐12/23 agents for moderate‐to‐severe psoriasis. We aimed to examine the risk of MACEs in adult patients with plaque psoriasis that are exposed to biologic therapies via a meta‐analysis of randomized controlled trials (RCTs). Data were obtained from systematic searches in the Cochrane Library, MEDLINE and Embase, U.S. Food and Drug Administration, European Medicines Agency, individual pharmaceutical companies online search platforms and five trials registers (up to 31 March 2016). We selected RCTs reporting adverse events in adults with plaque psoriasis receiving at least one licensed dose of biologic therapy, conventional systematic therapy or placebo. We calculated Peto odds ratios (ORs) with 95% confidence intervals (CIs) and calculated I 2 statistics to assess heterogeneity. Overall, 38 RCTs involving 18 024 patients were included. No MACEs were observed in 29 studies, while nine RCTs reported 10 patients experiencing MACEs. There was no statistically significant difference in risk of MACEs associated with the use of biologic therapies overall (OR 1·45, 95% CI 0·34–6·24); tumour necrosis factor‐α inhibitors (adalimumab, etanercept and infliximab) (OR 0·67, 95% CI 0·10–4·63); anti‐IL‐17A agents (secukinumab and ixekizumab) (OR 1·00, 95% CI 0·09–11·09) or ustekinumab (OR 4·48, 95% CI 0·24–84·77). No heterogeneity was observed in these comparisons. In conclusion, the limited existing evidence suggests that licensed biologic therapies are not associated with MACEs during the short randomized controlled periods in clinical trials.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Impact of biologic therapies on risk of major adverse cardiovascular events in patients with psoriasis: systematic review and meta-analysis of randomized controlled trials

et al. 2017

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“…26 Adverse events reported over 5 years were comparable with those reported for other biologic agents. 28 No cumulative or dose-related toxicity was observed.…”

Section: Infliximabmentioning

confidence: 92%

2016 Addendum to the Canadian Guidelines for the Management of Plaque Psoriasis 2009

Papp¹,

Gulliver²,

Lynde³

et al. 2016

J Cutan Med Surg

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Notes to Readers Disclaimer: As in the original guidelines, physicians should use their best clinical judgment when determining whether and how to apply treatment recommendations in the individualized care of patients. This document is not intended to replace the guidance found in the relevant Canadian product monographs or other official information available for the therapeutics discussed. Every reasonable effort has been made to ensure the accuracy of this document. Any errors made here will be corrected in the next edition of the guidelines. Drug recall: Please disregard all previous recommendations for alefacept, as it was withdrawn from the market in 2011. Drug names: As in the original guidelines document, generic names have been used throughout this document. Any new trade name or generic name used in the addendum has been has listed in Appendix I at the end of this document.

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“…However, 13 of 20 (65%) and 2 of 4 (50%) in the combined guselkumab and placebo groups, respectively, experienced at least 1 AE, which the most common of them was infections. Recently, in phase 2 trial, the efficiency of guselkumab with different doses, adalimumab, and placebo in patients with moderate to severe plaque psoriasis [64] . The results demonstrate that guselkumab led to significantly higher improvement compare to adalimumab and placebo (P<0.05 and P<0.02, respectively).…”

Section: Guselkumabmentioning

confidence: 99%

Anti-interleukin and associated receptors monoclonal antibodies therapy in autoimmune diseases

2016

Receptors Clin Investig

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There are nearly 40 approved monoclonal antibodies (mABs) in the U.S. for different diseases. These drugs are increasingly using in different autoimmune diseases, including rheumatoid arthritis (RA), asthma, psoriasis, systemic lupus erythematosus (SLE), atopic dermatitis (AD), multiple sclerosis (MS), and type 1 diabetes (T1D). Several phase 2 and 3 studies reported the clinical improvement due to treating with mABs. However, some adverse events (AEs) such as infections, injection-site reactions are frequently reported. In addition to approved diseases, off-label uses also led to some new results, which may cause reviewing the drug for other diseases. In this review, it was tried to discuss on the role of mABs that target interleukins or their associated receptors in treatment of autoimmune diseases. Moreover, approval statues, efficiency, safety and the possible associated AEs of the mABs on the market, based on the least clinical trials were also discussed.

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A Phase 2 Trial of Guselkumab versus Adalimumab for Plaque Psoriasis

Abstract: The results of this phase 2 trial suggest that guselkumab may be an effective therapy for plaque psoriasis and that control of psoriasis can be achieved with specific anti-interleukin-23 therapy. (Funded by Janssen Research and Development; X-PLORE ClinicalTrials.gov number, NCT01483599.).

Cited by 268 publications

References 29 publications

Impact of biologic therapies on risk of major adverse cardiovascular events in patients with psoriasis: systematic review and meta-analysis of randomized controlled trials

Impact of biologic therapies on risk of major adverse cardiovascular events in patients with psoriasis: systematic review and meta-analysis of randomized controlled trials

2016 Addendum to the Canadian Guidelines for the Management of Plaque Psoriasis 2009

Anti-interleukin and associated receptors monoclonal antibodies therapy in autoimmune diseases

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