Secukinumab for Long‐Term Treatment of Psoriatic Arthritis: A Two‐Year Followup From a Phase III, Randomized, Double‐Blind Placebo‐Controlled Study

Kavanaugh, Arthur; Mease, Philip J.; Reimold, Andreas M.; Tahir, Hasan; Rech, Jürgen; Hall, Stephen; Geusens, Piet; Wang, Zailong; Pricop, Luminita; Mpofu, S.

doi:10.1002/acr.23111

Cited by 78 publications

(89 citation statements)

References 27 publications

(46 reference statements)

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“…In agreement with previous studies (3,8,9,11,(13)(14)(15)(16), secukinumab treatment in FUTURE 1 was shown to be efficacious in both anti-TNF-naïve and anti-TNF-IR patients, with clinical responses generally higher in anti-TNF-naïve patients than in anti-TNF-IR patients. Improvement in ACR and PASI responses was achieved in patients who escalated from secukinumab 150 to 300 mg, indicating a benefit of dose escalation in patients who require additional control of symptoms.…”

Section: Discussionsupporting

confidence: 90%

“…The safety profile of secukinumab was consistent with that previously reported for PsA (3,9,(12)(13)(14)(15)(16)(17) and psoriasis (6). No new or unexpected safety signals were observed in patients with PsA over a treatment period of up to 5 years.…”

Section: Discussionsupporting

confidence: 87%

“…The study design of FUTURE 1 has been described in detail elsewhere (3). The study design of FUTURE 1 has been described in detail elsewhere (3).…”

Section: Methodsmentioning

confidence: 99%

“…Psoriatic arthritis (PsA) is a chronic, inflammatory disease characterized by peripheral arthritis, axial disease, dactylitis, enthesitis, and skin and nail psoriasis (1,2). PsA can negatively affect patients' daily functioning and quality of life as a result of permanent joint damage and disability (3). The reported prevalence of PsA in the general population is up to 1%, and it affects around 30% of patients with psoriasis (2,4,5).…”

Section: Introductionmentioning

confidence: 99%

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Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5‐year Results from the Phase 3 FUTURE 1 Study

Mease

Kavanaugh

Reimold

et al. 2019

ACR Open Rheumatology

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on behalf of the FUTURE 1 study groupObjective. To report the 5-year efficacy and safety of secukinumab in the treatment of patients with psoriatic arthritis (PsA) in the FUTURE 1 study (NCT01392326).Methods. Following the 2-year core trial, eligible patients receiving subcutaneous secukinumab entered a 3-year extension phase. Results are presented for key efficacy endpoints for the secukinumab 150-mg group (n = 236), including patients who escalated from 150 to 300 mg (approved doses) starting at week 156. Safety is reported for all patients (n = 587) who received 1 dose or more of study treatment.Results. Overall, 81.8%% (193 of 236) of patients in the secukinumab 150-mg group completed 5 years of treatment, of which 36.4% (86 of 236) had dose escalation from 150 to 300 mg. Sustained improvements were achieved with secukinumab across all key efficacy endpoints through 5 years. Overall, 71.0%/51.8%/36.3% of patients achieved American College of Rheumatology (ACR) 20/50/70 responses at 5 years. Efficacy improved in patients requiring dose escalation from 150 to 300 mg and was comparable with those who did not require dose escalation. Exposure-adjusted incidence rates for selected adverse events per 100 patient-years for any secukinumab dose were serious infections (1.8), Crohn's disease (0.2), Candida infection (0.9), and major adverse cardiac events (0.5).Conclusion. Secukinumab provided sustained improvements in the signs and symptoms in the major clinical domains of PsA. Efficacy improved for patients requiring dose escalation from 150 to 300 mg during the study. Secukinumab was well tolerated with no new safety signals.Dr. Mease was recipient of grant/research support from AbbVie, Amgen,

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Section: Discussionsupporting

confidence: 90%

Section: Discussionsupporting

confidence: 87%

“…The study design of FUTURE 1 has been described in detail elsewhere (3). The study design of FUTURE 1 has been described in detail elsewhere (3).…”

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5‐year Results from the Phase 3 FUTURE 1 Study

Mease

Kavanaugh

Reimold

et al. 2019

ACR Open Rheumatology

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“…[29][30][31] These anti-IL-17A biologics have been shown effective in psoriasis as demonstrated by their high PASI 75 response rates (71-83% at 12 weeks). [29][30][31] Anti-IL-17A biologics have also been shown to improve symptoms of psoriatic arthritis, 32,33 ankylosing spondylitis 34 and rheumatoid arthritis. 35 In Phase II studies of patients with IBD, blocking IL-17A was ineffective.…”

Section: Introductionmentioning

confidence: 99%

Shifting the focus – the primary role of IL‐23 in psoriasis and other inflammatory disorders

Gooderham

Papp

Lynde

2018

Acad Dermatol Venereol

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Insights into the pathophysiology of autoimmune inflammatory diseases including psoriasis have advanced considerably in recent years, and in parallel, so too have the available treatment options. Current clinical paradigms for the treatment of psoriasis have evolved to include targeted biologic therapies, starting with tumour necrosis factor‐alpha (TNF‐α) inhibitors and later, agents targeting interleukin (IL)‐12/23 and IL‐17. The most recent evidence suggests that IL‐23 might be an even more potent target for the effective treatment of psoriasis and other autoimmune inflammatory disorders. This review will describe recent developments leading to the current understanding of the key role of IL‐23 as a ‘master regulator’ of autoimmune inflammation and the clinical evidence for agents that specifically target this modulator in the context of treating psoriasis, spondyloarthropathy and inflammatory bowel disease.

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Risk of Infections and Cancer in Patients With Rheumatologic Diseases Receiving Interleukin Inhibitors

et al. 2019

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Key PointsQuestionWhat is the risk of serious infections, opportunistic infections, and cancer in patients with rheumatologic diseases treated with interleukin inhibitors?FindingsIn this systematic review and meta-analysis of 74 randomized clinical trials comprising 29 214 patients, pooled results suggest that risk of serious infections, opportunistic infections, and cancer is increased in patients with rheumatologic diseases who are treated with interleukin inhibitors compared with placebo.MeaningThis analysis suggests estimates of risk for infections and cancer associated with the use of interleukin inhibitors that can inform shared decision-making when patients and clinicians are contemplating the use of interleukin inhibitors for rheumatologic diseases.

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Secukinumab for Long‐Term Treatment of Psoriatic Arthritis: A Two‐Year Followup From a Phase III, Randomized, Double‐Blind Placebo‐Controlled Study

Abstract: Secukinumab provided sustained improvements in PsA at 2 years, with very little radiographic progression. Treatment was well tolerated over the long term.

Cited by 78 publications

References 27 publications

Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5‐year Results from the Phase 3 FUTURE 1 Study

Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5‐year Results from the Phase 3 FUTURE 1 Study

Shifting the focus – the primary role of IL‐23 in psoriasis and other inflammatory disorders

Risk of Infections and Cancer in Patients With Rheumatologic Diseases Receiving Interleukin Inhibitors

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