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- |||||||| Efleira (netakimab) / Biocad
New P3 trial: PLANETA-KIDS: Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Netakimab in Children with Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - Oct 15, 2024
P3, N=140, Recruiting, Sponsor: Biocad
- || Efleira (netakimab) / Biocad
Clinical, Retrospective data, Journal, Real-world evidence, Real-world: Real-World Retention Rate, Effectiveness, and Safety of Netakimab in the Treatment of Patients with Ankylosing Spondylitis: First Year Results of the LIBRA Post-Registration Safety Study. (Pubmed Central) - Sep 24, 2024
: In real-world clinical practice, netakimab demonstrated high retention rates, a favorable safety profile, and sustained efficacy throughout the first year of therapy.
- Efleira (netakimab) / Biocad
Successful intra-class switching to novel IL-17 inhibitor netakimab in patients with plaque psoriasis in real-world practice (Poster Area) - Aug 5, 2024 - Abstract #EADV2024EADV_4933;
: In real-world clinical practice, netakimab demonstrated high retention rates, a favorable safety profile, and sustained efficacy throughout the first year of therapy. This prospective, real-world study demonstrated that switching to NTK after previous ineffectiveness of other IL- 17i is a promising strategy, resulting in durable responses in the majority of patients and an improvement in quality of life.
- Efleira (netakimab) / Biocad
Efficacy and Safety of Netakimab Through 3 Years in Moderate-to-Severe Psoriasis: Long-Term Results from the PLANETA Phase-3 Randomized Controlled Trial (Poster Area) - Aug 5, 2024 - Abstract #EADV2024EADV_4893;
P3
Figure 1. PASI75/PASI90/PASI100 response rate during the long-term extension period (n=147) Figure 2.
- | Cosentyx (secukinumab) / Novartis, Efleira (netakimab) / Biocad
Journal: Course of Uveitis in Patients with Ankylosing Spondylitis during the Interleukin17 Inhibitors Therapy. (Pubmed Central) - Jun 11, 2024
There were no significant differences in the incidence rates of uveitis during IL17-i therapy compared with non-biological therapy. IL17-i therapy have not demonstrated a significant effect on the course of uveitis in AS in the study group.
- || Efleira (netakimab) / Biocad
Clinical, Review, Journal: Current treatment for spondyloarthritis: focus on netakimab. A review (Pubmed Central) - Jun 3, 2024
The drug has low immunogenicity, which allows us to count on the possibility of many years of effective use. Resolutions of expert councils on the use of NTK in AS and PsA support the inclusion of this drug in clinical guidelines.
- | Efleira (netakimab) / Biocad
Retrospective data, Journal, Real-world evidence, Real-world: Real-world experience with netakimab in the treatment of spondyloarthritis (Pubmed Central) - May 24, 2024
Resolutions of expert councils on the use of NTK in AS and PsA support the inclusion of this drug in clinical guidelines. The obtained data confirm the effectiveness and safety of netakimab in treating AS and PsA in real-world practice.
- | Efleira (netakimab) / Biocad
Retrospective data, Journal: Response to netakimab in radiographic axial spondyloarthritis patients with different baseline C-reactive protein, sacroiliitis evaluated by MRI and peripheral joint involvement status: a post-hoc analysis of the ASTERA study. (Pubmed Central) - Mar 28, 2023
P3
Subcutaneous netakimab is effective in patients with r-axSpA irrespective of baseline CRP and inflammation on SIJ MRI. The benefit in patients with high CRP (>20 mg/L) was more pronounced.
- ||| Efleira (netakimab) / Biocad
Trial completion date: ASTERA: International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing Spondylitis (clinicaltrials.gov) - Feb 21, 2023
P3, N=228, Active, not recruiting, Sponsor: Biocad
The benefit in patients with high CRP (>20 mg/L) was more pronounced. Trial completion date: Mar 2022 --> Apr 2023
- | Efleira (netakimab) / Biocad
Journal: Two Epitope Regions Revealed in the Complex of IL-17A and Anti-IL-17A VH Domain. (Pubmed Central) - Dec 12, 2022
Netakimab is an IL-17A-specific antibody containing a Lama glama VH derivative domain and a VL variable domain...The β-turn of IL-17A, which forms the so-called epitope-1, appears to be the main region of IL-17A interaction with the antibody. Contacts formed by the IL-17A mobile C-terminal region residues (epitope-2) further stabilize the antibody-antigen complex.
- | Journal: Biological treatment for erythrodermic psoriasis. (Pubmed Central) - Sep 30, 2022
Management of patients with prior biologic failure remains a challenge. Guidelines for the management of EP need to be revisited in light of the recent advances.
- Efficacy and Safety of Biological DMARDs: A Systematic Literature Review Informing the 2022 Update of the ASAS-EULAR Recommendations for the Management of Axial Spondyloarthritis (Virtual Poster Hall) - Sep 17, 2022 - Abstract #ACRConvergence2022ACR_CONVERGENCE_2011;
This systematic review provides important new insights into the management of patients with bDMARDs, across the entire spectrum of axSpA.Figure 1. ASAS40 response in placebo-controlled RCTs of IL-17 inhibitors, by axSpA subtype.
- Efficacy of Targeted Drugs for the Treatment of Adults With Moderate-to-Severe Plaque Psoriasis in the Russian Federation: Number Needed to Treat and Costs Per Responder (Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_2467;
This study complements the systematic review and meta-analysis of the efficacy of targeted drugs to treat adults with moderate-to-severe plaque psoriasis in the Russian Federation. The results may become a useful tool for treatment decision-making.
- Efficacy of Targeted Drugs for the Treatment of Adults With Moderate-to-Severe Plaque Psoriasis in the Russian Federation: A Systematic Literature Review Update (Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_737;
Evidence synthesis included RCTs evaluating the efficacy of adalimumab (ADA), infliximab (INF), etanercept (ETN), certolizumab pegol (CZP), ixekizumab (IXE), netakimab (NTK), secukinumab (SEC), risankizumab (RIS), guselkumab (GUS), ustekinumab (UST), tofacitinib (TOFA), and apremilast (APR) after 12 weeks of therapy. The addition of head-to-head trials and increased statistical power of the network revealed previously unidentified significant differences between treatment options for moderate-to-severe plaque psoriasis.
- | Olumiant (baricitinib) / Incyte, Eli Lilly, Actemra IV (tocilizumab) / Roche, JW Pharma, Efleira (netakimab) / Biocad
Observational data, Journal: Tocilizumab, netakimab, and baricitinib in patients with mild-to-moderate COVID-19: An observational study. (Pubmed Central) - Aug 31, 2022
The significant increase in blood neutrophil count in the netakimab group may reflect efflux of neutrophils from inflamed tissues. We therefore hypothesize that neutrophil count and neutrophil-to-lymphocyte ratio could serve as markers of therapeutic efficiency for IL-17A-blocking antibodies in the context of active inflammation.
- Efleira (netakimab) / Biocad
Cardiovascular risk assessment in patients with psoriasis. (e-Poster Hall) - Jun 13, 2022 - Abstract #EADVSp2022EADV_Sp_480;
Moreover, a direct relationship between the severity of psoriasis and cardiovascular risk was observed. However, further prospective randomized trials as well as a multidisciplinary therapeutic approach and biobanking will help assess the probability of CVD development in patients with psoriasis.
- ||||||| Efleira (netakimab) / Biocad
Trial completion: BCD-085-7: An International Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Study of Efficacy and Safety of Two Dosing Regimens of BCD-085 (JSC BIOCAD, Russia) in Patients With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - Jun 1, 2022
P3, N=213, Completed, Sponsor: Biocad
However, further prospective randomized trials as well as a multidisciplinary therapeutic approach and biobanking will help assess the probability of CVD development in patients with psoriasis. Active, not recruiting --> Completed
- | Olumiant (baricitinib) / Incyte, Eli Lilly, Actemra IV (tocilizumab) / Roche, JW Pharma, Efleira (netakimab) / Biocad
New trial: COVID-19 Study at the Russian Clinical and Research Center of Gerontology of the Pirogov RNRMU (clinicaltrials.gov) - Mar 31, 2022
P=N/A, N=154, Completed, Sponsor: Pirogov Russian National Research Medical University
- ||| Clinical, Retrospective data, Review, Journal, Adverse events: Immune-related adverse events (irAEs) in ankylosing spondylitis (AS) patients treated with interleukin (IL)-17 inhibitors: a systematic review and meta-analysis. (Pubmed Central) - Mar 29, 2022
Active, not recruiting --> Completed The most common immune system-related AEs in patients treated with IL-17 inhibitors are mucosal and opportunistic infections.
- || Retrospective data, Review, Journal: Efficacy and safety of interleukin-17 inhibitors in the treatment of chronic rheumatic diseases: A combined and updated meta-analysis. (Pubmed Central) - Dec 16, 2021
The most common immune system-related AEs in patients treated with IL-17 inhibitors are mucosal and opportunistic infections. In this meta-analysis, our findings found interleukin-17 inhibitors had a significant clinical benefit in the management of AS/PsA patients.
- Course of COVID-19 infection in patients with arthritis receiving targeted DMARDs (data Moscow Unified Arthritis Registry) () - Nov 7, 2021 - Abstract #APLAR2021APLAR_471;
Used of tsDMARDs doesn’t reliably increase the risk of COVID-19 severity. There is reliable correlation between age and COVID-19 severity.
- || Efleira (netakimab) / Biocad
Clinical, Retrospective data, Journal: Anti-IL-17 monoclonal antibodies in hospitalized patients with severe COVID-19: A pilot study. (Pubmed Central) - Sep 1, 2021
There is reliable correlation between age and COVID-19 severity. In hospitalized patients with severe COVID-19, anti-IL-17 therapy might mitigate the inflammatory response and improve oxygenation, but do not affect the need for mechanical ventilation and mortality.
- | Actemra IV (tocilizumab) / Roche, JW Pharma, Efleira (netakimab) / Biocad
Journal: Interleukin 17 antagonist netakimab is effective and safe in the new coronavirus infection (COVID-19). (Pubmed Central) - Aug 15, 2021
There was no difference in the incidence of side effects between groups. The IL-17 antagonist netakimab is effective and safe in the treatment of cytokine release syndrome in COVID-19.
- || Retrospective data, Review, Journal: Efficacy and safety of interleukin-17A inhibitors in patients with ankylosing spondylitis: a systematic review and meta-analysis of randomized controlled trials. (Pubmed Central) - Jul 23, 2021
IL-17A inhibitors demonstrated better efficacy in patients with AS in several evaluation indicators. However, the safety of IL-17A inhibitors remains to be further studied in studies with larger sample size and longer follow-up times.
- || Review, Journal: Latest Advances for the Treatment of Chronic Plaque Psoriasis with Biologics and Oral Small Molecules. (Pubmed Central) - Jul 10, 2021
Additional molecules are in an early phase of development. Highly promising biologicals and small oral molecules are the leading edge of the systemic treatment of psoriasis.
- | Efleira (netakimab) / Biocad
I haven’t used it but… Netakimab (IL-17i) approved for treatment of PsO, AS, and PsA in Russia and Belarus ⭐️⬇️AS activity w/ or w/o MRI sacroilitis Abs#OP0142 #EULAR2021 @RheumNow (Twitter) - Jun 3, 2021
- || Efleira (netakimab) / Biocad
#EULAR2021 Que os parece la eficacia de NETAKIMAB en EA en función de la RMN?👇👇👇👇👇👇👇👇👇👇👇 @GRESSER_Espa @SMurcianaReuma (Twitter) - Jun 3, 2021
- || Efleira (netakimab) / Biocad
Clinical, Journal: 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. (Pubmed Central) - Jun 2, 2021
P3
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.
- [VIRTUAL] THE COURSE OF COVID-19 INFECTION IN PATIENTS WITH ARTHRITIS RECEIVING TARGETED DMARDS () - May 21, 2021 - Abstract #EULAR2021EULAR_3490;
Used of tsDMARDs doesn’t reliably increase the risk of COVID-19 severity. There is reliable correlation between age and COVID-19 severity.
- Efleira (netakimab) / Biocad
[VIRTUAL] COMPARISON OF EQ-5D HEALTH STATUS IN PSORIATIC ARTHRITIS PATIENTS WITH OR WITHOUT AXIAL DISEASE: RESULTS OF SUBANALYSIS OF THE PATERA STUDY () - May 21, 2021 - Abstract #EULAR2021EULAR_2440;
P3
IBP(-) subjects showed trend to greater benefit compared to IBP(+). Figure 1 Percentage of patients reported any problems in (A) pain/discomfort, (B) in usual activity at each visit
- Efleira (netakimab) / Biocad
[VIRTUAL] THE IMPACT OF AXIAL INVOLVEMENT ON ACR RESPONSE IN PATIENTS WITH PSORIATIC ARTHRITIS: RESULTS OF SUBANALYSIS OF THE PATERA STUDY () - May 21, 2021 - Abstract #EULAR2021EULAR_2434;
P3
Both IBP(-) and IBP(+) subpopulations achieved ACR20/50/70 as well, however, the benefit in IBP(-) patients was more pronounced. Figure 1 ACR response rates
- Efleira (netakimab) / Biocad
[VIRTUAL] NETAKIMAB REDUCES PSORIATIC ARTHRITIS ACTIVITY IN PATIENTS WITH OR WITHOUT AXIAL DISEASE: SUBANALYSIS OF THE PATERA STUDY (Posters Viewing) - May 21, 2021 - Abstract #EULAR2021EULAR_2493;
P3
PsA activity after 24-week treatment with NTK. (A) Percentage of patients with DAPSA remission (0-4), very low disease activity (VLDA), minimal disease activity (MDA) at week 24; (B) change from baseline in DAS28-CRP
- [VIRTUAL] TREATMENT SURVIVAL ON BIOLOGICS IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS – DATA FROM MOSCOW UNIFIED ARTHRITIS REGISTRY (MUAR) (Posters Viewing) - May 21, 2021 - Abstract #EULAR2021EULAR_2193;
There are significant differences between biologics regarding retention on treatment. Hazard ratio for treatment withdrawal * - withdrawal risk relative to ETA Picture 1.
- Efleira (netakimab) / Biocad
[VIRTUAL] NETAKIMAB EFFICACY IN ANTI-TNF-NAIVE AND ANTI-TNF-EXPERIENCED PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS: RESULTS OF SUBANALYSIS OF PHASE 3 ASTERA TRIAL (Posters Viewing) - May 21, 2021 - Abstract #EULAR2021EULAR_2177;
P3
Hazard ratio for treatment withdrawal * - withdrawal risk relative to ETA Picture 1. NTK 120 mg provided sustained improvements in signs and symptoms of AS in anti-TNF-naive and anti-TNF-IR patients at 16 weeks of therapy.
- || Review, Journal: Anti-IL-17 Agents in the Treatment of Axial Spondyloarthritis. (Pubmed Central) - May 13, 2021
The last ten years have seen the development of a number of therapeutic recommendations that aimed at improving the management of axSpA patients. The aim of this narrative review of the published literature concerning the role of IL-17 in the pathogenesis of SpA, and the role of IL-17 inhibitors in the treatment of axSpA, is to provide a comprehensive picture of the clinical efficacy and safety of the drugs themselves, and the treatment strategies recommended in the international guidelines.
- [VIRTUAL] Number Needed to Treat and Incremental Costs per Responder for Biologics in Adult Patients with Active Radiographic Axial Spondyloarthritis in the Russian Federation () - Apr 12, 2021 - Abstract #ISPOR2021ISPOR_92;
The highest CpR was attributed to etanercept 25 mg. CONCLUSIONS The analyses resulted in netakimab being the most cost-effective treatment option, while etanercept 25 mg was the least cost-effective among biologics to treat active r-AxSpA in Russia.
- [VIRTUAL] Biologics to Treat Adults with Active Radiographic Axial Spondyloarthritis in the Russian Federation- Number Needed to Treat and Cost per Responder () - Apr 12, 2021 - Abstract #ISPOR2021ISPOR_91;
CONCLUSIONS This study complements the systematic review and network meta-analysis of relative effectiveness of biologics in adults with active r-AxSpA in Russia. The results may be a useful tool for treatment decision-making.
- Efleira (netakimab) / Biocad
[VIRTUAL] NETAKIMAB REDUCES ANKYLOSING SPONDYLITIS ACTIVITY IN PATIENTS WITH OR WITHOUT SACROILIITS ON MRI: RESULTS OF SUBANALYSIS OF PHASE 3 ASTERA TRIAL (Room 7) - Apr 6, 2021 - Abstract #EULAR2021EULAR_1362;
P3
The results may be a useful tool for treatment decision-making. NTK leads to decline of disease activity in AS pts irrespectively of sacroiliitis on MRI.
- | Xeljanz (tofacitinib) / Pfizer, Marche Polytechnic University
Journal: Emerging systemic drugs in the treatment of plaque psoriasis. (Pubmed Central) - Feb 4, 2021
There seems to be limited room for development of novel biologics, as the existing ones are extraordinarily safe, effective, and convenient with few injections. Patients would prefer a safe, effective oral treatment; however, JAK inhibitors seem unlikely to fill this role completely.
- [VIRTUAL] Comparative Efficacy of Synthetic and Biologic Dmards for Adult Patients with ACTIVE Psoriatic Arthritis in the Russian Federation- A Systematic Review and Network Meta-Analysis () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_1847;
Phase II and III randomised controlled trials (RCTs) evaluating efficacy of sDMARDS (tofacitinib, apremilast) and bDMARDS (netakimab, guselkumab, ustekinumab, secukinumab, ixekizumab, adalimumab, etanercept, infliximab, certolizumab, golimumab) for active PsA were identified by systematic literature review performed in Pubmed and Embase databases. Netakimab is one of the most effective treatments for active PsA.
- [VIRTUAL] Budget IMPACT Analysis of Secukinumab in the Treatment of Ankylosing Spondylitis By the Biological Therapy in the Russian Federation () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_339;
With the current distribution of patients, adalimumab received 26%, golimumab - 14%, infliximab - 26%, etanercept 18%, certolizumab pegol 7%, secukinumab - 9%...Also, in the simulated distribution, the shares of recently registered drugs - netakimab - 6.8%, and ixekizumab - 2.6% were taken into account...Thus, when calculating per 100 patients, the simulated distribution of patients in comparison with the current one provided savings in the amount of €102 335 in the first year and €226 936 for three years. CONCLUSIONS : From budget impact analysis perspective increasing share of secukinumab in the treatment of ankylosing spondylitis by the biological therapy provided cost-savings.
- || Efleira (netakimab) / Biocad
Trial completion date: PATERA: Clinical Study of Efficacy and Safety of BCD-085 (Monoclonal Anti-IL-17 Antibody) in Psoriatic Arthritis (clinicaltrials.gov) - Jul 22, 2020
P3, N=194, Active, not recruiting, Sponsor: Biocad
CONCLUSIONS : From budget impact analysis perspective increasing share of secukinumab in the treatment of ankylosing spondylitis by the biological therapy provided cost-savings. Trial completion date: Jan 2021 --> Nov 2022
- ||| Efleira (netakimab) / Biocad
Trial completion date: ASTERA: International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing Spondylitis (clinicaltrials.gov) - Jul 22, 2020
P3, N=228, Active, not recruiting, Sponsor: Biocad
Trial completion date: Jan 2021 --> Nov 2022 Trial completion date: Feb 2020 --> Mar 2022
- || Efleira (netakimab) / Biocad
Clinical, Journal: Primary efficacy of netakimab, a novel interleukin-17 inhibitor, in the treatment of active ankylosing spondylitis in adults. (Pubmed Central) - Jul 19, 2020
The data obtained demonstrate the efficacy and favourable safety profile of NTK in active AS. Clinical development of NTK will be continued in a phase 3 trial aimed to evaluate the efficacy of 1-year treatment with NTK 120 mg in patients with AS.
- | Biomarker, Review, Journal: State of the art and pharmacological pipeline of biologics for chronic plaque psoriasis. (Pubmed Central) - Jun 26, 2020
The availability of biosimilars at much lower cost compared to originators is dramatically changing the access of patients to these treatments. In the coming years, studies will progress to identify subgroups of patients based on biomarkers for a more personalized treatment approach.
- |||| Efleira (netakimab) / Biocad
Clinical: #eular2020 #op0226 humanized antiIL17a ab NETAKIMAB (NTK)for PsA Ph3 PATERA trial: pts who failed cDMARDs and/or 1TNFi experience significantly ⬆️ ACR20/50/70 &PsACR response vs PBO. DAPSA remission 36.08% NTK vs 13.4%PBO. AEs: lympho&neutropenia, ⬆️cholesterol,⬆️bili @RheumNow (Twitter) - Jun 5, 2020
- Efleira (netakimab) / Biocad
[VIRTUAL] EFFICACY OF NETAKIMAB IN THE TREATMENT OF AXIAL DISEASE IN PATIENTS WITH PSORIATIC ARTHRITIS: RESULTS OF SUBANALYSIS FROM A DOUBLE-BLIND RANDOMIZED PHASE 3 TRIAL (PATERA) (Poster View) - May 22, 2020 - Abstract #EULAR2020EULAR_2658;
P3
About 50% of subjects, randomized to PATERA study, had IBP at baseline. NTK leads to rapid and sustained improvement in axial disease in patients with active PsA.
- Efleira (netakimab) / Biocad
[VIRTUAL] NETAKIMAB REDUCES SKIN MANIFESTATIONS OF PSORIATIC ARTHRITIS: RESULTS OF SUBANALYSIS FROM A DOUBLE-BLIND RANDOMIZED PHASE 3 STUDY (PATERA) () - May 22, 2020 - Abstract #EULAR2020EULAR_2564;
P3
NTK leads to rapid and sustained improvement in axial disease in patients with active PsA. 24-week treatment with NTK at the dose of 120 mg resulted in significant improvement in skin manifestations in PsA patients: more than half of the patients with BSA≥3 at BL achieved complete skin clearance.
- Efleira (netakimab) / Biocad
[VIRTUAL] NETAKIMAB IMPROVES PATIENT-REPORTED OUTCOMES IN PATIENTS WITH PSORIATIC ARTHRITIS: RESULTS FROM A RANDOMIZED DOUBLE-BLIND PHASE 3 TRIAL (PATERA) () - May 22, 2020 - Abstract #EULAR2020EULAR_2275;
P3
24-week treatment with NTK at the dose of 120 mg resulted in significant improvement in skin manifestations in PsA patients: more than half of the patients with BSA≥3 at BL achieved complete skin clearance. NTK demonstrated rapid improvement in QoL, work productivity and physical function in pts with PsA.
- ||| Efleira (netakimab) / Biocad
Trial completion date: BCD-085-7: An International Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Study of Efficacy and Safety of Two Dosing Regimens of BCD-085 (JSC BIOCAD, Russia) in Patients With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - May 21, 2020
P3, N=213, Active, not recruiting, Sponsor: Biocad
NTK demonstrated rapid improvement in QoL, work productivity and physical function in pts with PsA. Trial completion date: Jul 2019 --> Jan 2022