OP0234 EFFICACY AND SAFETY OF BRODALUMAB, AN ANTI-INTERLEUKIN-17 RECEPTOR A MONOCLONAL ANTIBODY, IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS: A 16 WEEK RESULTS OF A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

ObjectiveTo investigate the efficacy and safety of brodalumab, a fully human anti-interleukin-17 receptor A monoclonal antibody, in patients with axial spondyloarthritis (axSpA).MethodsIn a multicentre, placebo-controlled phase 3 study (NCT02985983) conducted at 48 sites across Japan, Korea and Taiwan, patients with axSpA were randomised 1:1 to receive subcutaneous brodalumab 210 mg (n=80) or placebo (n=79) at baseline, weeks 1 and 2 and every 2 weeks thereafter, during the 16-week double-blind period. The primary endpoint was the proportion of patients with Assessment of SpondyloArthritis International Society (ASAS) 40 response at week 16. Secondary endpoints included the proportion of patients with ASAS 20 response and change in Ankylosing Spondylitis Disease Activity Score using C-reactive protein (ASDAS-CRP) at week 16 and safety.ResultsASAS 40 response rate (n/N; 95% CI) was 43.8% (35/80; 32.7, 55.3) with brodalumab vs 24.1% (19/79; 15.1, 35.0) with placebo (rate difference, 19.7% (5.3, 34.1); p=0.018 by stratified Cochran-Mantel-Haenszel test). ASAS 20 response rate (n/N; 95% CI) was 67.5% (54/80; 56.1, 77.6) vs 41.8% (33/79; 30.8, 53.4) and least squares mean change (95% CI) from baseline (brodalumab, 2.660; placebo, 2.716) in ASDAS-CRP was –1.127 (–1.322, –0.931) with brodalumab vs –0.672 (–0.872, –0.473) with placebo at week 16. Treatment-emergent adverse events were reported in 44 (55%) and 45 (57%) patients in the brodalumab and placebo groups, respectively.ConclusionBrodalumab demonstrated a significant improvement at week 16 in patients with active axSpA. Safety of brodalumab was consistent with that reported in previous global/Japanese psoriasis studies.

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Faculty Opinions recommendation of Efficacy and safety of subcutaneous tabalumab, a monoclonal antibody to B-cell activating factor, in patients with systemic lupus erythematosus: results from ILLUMINATE-2, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.725732407.793547378 ◽

2018 ◽

Author(s):

Maria Laura Bertolaccini

Keyword(s):

Systemic Lupus Erythematosus ◽

Monoclonal Antibody ◽

Lupus Erythematosus ◽

Phase Iii ◽

Controlled Study ◽

Efficacy And Safety ◽

Systemic Lupus ◽

Double Blind ◽

Double Blind Placebo ◽

B Cell Activating Factor

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A phase 3, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of erenumab in migraine prevention: primary results of the arise trial

Journal of Neurology Neurosurgery & Psychiatry ◽

10.1136/jnnp-2017-316074.63 ◽

2017 ◽

Vol 88 (5) ◽

pp. e1.63-e1 ◽

Cited By ~ 8

Author(s):

David Dodick ◽

Messoud Ashina ◽

David Kudrow ◽

Michel Lanteri-Minet ◽

Vera Osipova ◽

...

Keyword(s):

Controlled Study ◽

Migraine Prevention ◽

Efficacy And Safety ◽

Phase 3 ◽

Double Blind ◽

Double Blind Placebo

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Efficacy and safety of netakimab, a novel anti-IL-17 monoclonal antibody, in patients with moderate to severe plaque psoriasis. Results of a 54-week randomized double-blind placebo-controlled PLANETA clinical trial

Vestnik dermatologii i venerologii ◽

10.25208/vdv1251 ◽

2021 ◽

Vol 97 (4) ◽

pp. 80-91

Author(s):

Luis Puig ◽

Andrey L. Bakulev ◽

Muza M. Kokhan ◽

Alexey V. Samtsov ◽

Vladislav R. Khairutdinov ◽

...

Keyword(s):

Clinical Trial ◽

Monoclonal Antibody ◽

Plaque Psoriasis ◽

Safety Data ◽

Interleukin 17 ◽

Efficacy And Safety ◽

Double Blind ◽

Double Blind Placebo ◽

Severe Plaque Psoriasis ◽

To Receive

Background. Netakimab (NTK), an original humanized anti-interleukin-17 monoclonal antibody, showed therapeutic efficacy in moderate to severe plaque psoriasis in a phase 2 clinical study. Herein we report the results of 54 weeks of a phase 3 trial. Aim. To evaluate the efficacy and safety of two NTK regimens vs. placebo in moderate to severe plaque psoriasis. Methods. PLANETA is the ongoing randomized double-blind placebo-controlled clinical trial. 213 patients with moderate to severe plaque psoriasis were randomly assigned to receive NTK 120 mg once every 2 weeks (NTK Q2W), NTK 120 mg once every 4 weeks (NTK Q4W) or placebo. During the first 3 weeks, patients received subcutaneous injections of NTK or placebo (according to the allocation) once a week. Patients in the NTK Q2W group then received NTK at weeks 4, 6, 8, and 10. Subjects in the NTK Q4W group received NTK at weeks 6 and 10 and placebo at weeks 4 and 8. Patients in the placebo group received placebo injections at weeks 4, 6, 8, and 10. Treatment was unblinded at week 12. During the open-label phase, patients in both NTK groups continued to receive NTK Q4W. The primary efficacy endpoint was the proportion of patients in each group who achieved a 75% or greater reduction from baseline in psoriasis area and severity index (PASI 75) at week 12. Results. A total of 77.7%, 83.3%, and 0% of patients had a PASI 75 response at week 12 in the NTK Q2W, NTK Q4W, and placebo groups, respectively (P 0.0001, Fishers exact test, ITT). The effect was maintained throughout the 1-year treatment. NTK showed a good safety profile and low immunogenicity. Conclusion. Treatment with NTK results in high rates of sustained clinical response in patients with moderate to severe plaque psoriasis. The study is ongoing; thus, long-term use efficacy and safety data are forthcoming.

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