Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, exhibits minimal immunogenicity in patients with moderate-to-severe plaque psoriasis

Reich, Kristian; Blauvelt, Andrew; Armstrong, April W.; Langley, Richard; Fox, Todd; Huang, Jie; Papavassilis, Charis; Liang, Eric; Lloyd, Peter; Bruin, Gerard

doi:10.1111/bjd.14965

Cited by 51 publications

(65 citation statements)

References 31 publications

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“…In particular, responses at week 12 were sustained through week 52 in the majority of patients. This observation may in part reflect minimal immunogenicity of secukinumab . Furthermore, we demonstrated the benefit of bio‐switch from tumor necrosis factor (TNF)‐α antagonists or IL‐12/23 p40 antagonist, in accordance with the result of a randomized clinical trial in Japan .…”

Section: Discussionsupporting

confidence: 73%

Long‐term clinical efficacy and safety of secukinumab for Japanese patients with psoriasis: A single‐center experience

Momose

Asahina

Umezawa

et al. 2017

The Journal of Dermatology

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Secukinumab is a fully human monoclonal antibody that can selectively neutralize interleukin-17A, and its excellent efficacy has been demonstrated in clinical trials for psoriasis. The aim of our study is to assess long-term efficacy and safety of secukinumab for 52 weeks in real-world clinical practise in our facility. A total of 83 patients (71 with psoriasis vulgaris and 12 with psoriatic arthritis) were included, and 49 of them were bio-switched patients. Psoriasis Area and Severity Index (PASI) 75 and PASI-90 responses were 80% and 64% at week 12, 77% and 65% at week 24, and 76% and 58% at week 52, respectively. No significant differences were observed in efficacy between bio-naive and bio-switched patients. Arthralgia showed improvement by week 12 in all patients with psoriatic arthritis with a reduction of serum C-reactive protein level. Treatment was discontinued in 22% (18/83), including eight patients with no improvement or exacerbation of cutaneous manifestations, one patient with new onset of arthritis and two patients with transient infection. Overall, secukinumab showed a sustained clinical response with an acceptable safety profile through week 52 in Japanese psoriatic patients.

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Section: Discussionsupporting

confidence: 73%

Long‐term clinical efficacy and safety of secukinumab for Japanese patients with psoriasis: A single‐center experience

Momose

Asahina

Umezawa

et al. 2017

The Journal of Dermatology

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“…In this study, ADAs were detected according to the assay approach described above using an MSD electrochemiluminescence assay (MSD, Gaithersburg, MD, USA), which has been previously described in detail . Two parameters of ADA assays are important to understand the quality of the derived data: (i) the lower limit of detection (sensitivity) and (ii) interference of residual drug in the patient‐derived sample with detection of ADA in the assay (drug interference).…”

Section: Methodsmentioning

confidence: 99%

“…Loss of response was defined as an increase in PASI of ≥6 points from the minimum PASI achieved on treatment . Furthermore, in SCULPTURE, start of relapse was defined as a loss of ≥20% of the maximum PASI gain achieved during the study compared with baseline as well as loss of PASI 75 response …”

Section: Methodsmentioning

confidence: 99%

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Secukinumab, a fully human anti‐interleukin‐17A monoclonal antibody, exhibits low immunogenicity in psoriasis patients treated up to 5 years

Reich

Blauvelt

Armstrong

et al. 2019

Acad Dermatol Venereol

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Background Secukinumab is a fully human monoclonal antibody that selectively neutralizes IL‐17A, a key cytokine involved in psoriasis and psoriatic arthritis development, and has shown rapid and long‐lasting efficacy and safety in the complete spectrum of psoriasis manifestations. Monoclonal antibody therapies may be associated with the production of treatment‐emergent antidrug antibodies (TE‐ADAs) that can affect drug pharmacokinetics, diminish clinical responses via inhibition of target binding or cause hypersensitivity reactions. Secukinumab exhibited minimal immunogenicity up to 52 weeks in patients with moderate‐to‐severe plaque psoriasis, as evidenced by TE‐ADA in <1% patients. Objective To investigate the immunogenicity of secukinumab treatment up to 5 years in two phase 3 extension studies (NCT01640951 and NCT01365455) in patients with moderate‐to‐severe plaque psoriasis. Methods Immunogenicity was evaluated up to Week 268 (5 years). TE‐ADAs were defined as positive antidrug antibody (ADA) signals detected in post‐treatment samples from patients with negative baseline signals. Confirmed positive samples were further analysed for their neutralizing potential. Results In total, 1821 patients entered the extension studies. Among patients receiving secukinumab and evaluated for ADAs (n = 1636), 32 developed TE‐ADA, which resulted in an incidence of new TE‐ADA cases below 1% per year. Neutralizing antibodies were detected in 9/32 (28%) patients with TE‐ADA. Half of ADA‐positive cases were transient. Among pharmacokinetic samples measured at the times of immunogenicity determination (n = 9992), 544 (5.4%) had secukinumab concentrations higher than the drug tolerance level of 53.8 μg/mL. There was no effect of TE‐ADA, including neutralizing antibodies, on efficacy, safety or pharmacokinetics of secukinumab. Conclusion The yearly secukinumab immunogenicity incidence over 5 years of treatment was consistently below 1% in patients with moderate‐to‐severe plaque psoriasis. Any TE‐ADAs, including neutralizing antibodies, were not associated with loss of secukinumab efficacy or with clinical concerns.

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“…[1] Only 0.4% of patients developed anti- secukinumab antibodies over 52 weeks. [2] Further, secukinumab and ustekinumab resulted in lower numbers of T-cell epitopes and lower T-cell response rates in humans, than did adalimumab and infliximab,[3] indicating that secukinumab has a low immunogenic potential and is well tolerated.…”

mentioning

confidence: 99%

Refractory psoriasis vulgaris with itching successfully treated with the anti-interleukin-17A antibody secukinumab: A case of secondary failure of other biologic agents

2017

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Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, exhibits minimal immunogenicity in patients with moderate-to-severe plaque psoriasis

Cited by 51 publications

References 31 publications

Long‐term clinical efficacy and safety of secukinumab for Japanese patients with psoriasis: A single‐center experience

Long‐term clinical efficacy and safety of secukinumab for Japanese patients with psoriasis: A single‐center experience

Secukinumab, a fully human anti‐interleukin‐17A monoclonal antibody, exhibits low immunogenicity in psoriasis patients treated up to 5 years

Refractory psoriasis vulgaris with itching successfully treated with the anti-interleukin-17A antibody secukinumab: A case of secondary failure of other biologic agents

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