Background:Netakimab (NTK) is a humanized anti-interleukin 17A antibody approved for the treatment of moderate-to-severe plaque psoriasis.Objectives:To determine the efficacy and safety of NTK in patients (pts) with active psoriatic arthritis (PsA), based on 24-week (Wk) data from an ongoing phase 3 study (NCT03598751, PATERA).Methods:194 eligible adult pts with PsA (CASPAR, 2006) with inadequate response to csDMARD or one TNFi, were randomized (1:1) to receive NTK 120 mg or placebo (PBO) subcutaneously at Wk 0, 1, 2, 4, 6, 8, 10, 14, 18, 22. 84 pts from PBO arm who did not meet ACR20 (20% improvement of the American College of Rheumatology criteria) by Wk 16 were switched to NTK 120 mg. The primary endpoint was AСR20 at Wk 24. DAPSA (Disease Activity Index for Psoriatic Arthritis), the proportion of pts achieved ACR50/70, minimal disease activity (MDA) (≥5/7 MDA criteria) and Psoriatic arthritis response criteria (PsARC) were also analyzed.Results:Baseline demographics and disease characteristics were similar across treatment arms (Table 1). 80 (82.47%) pts in NTK arm and 9 (9.28%) in the PBO arm achieved ACR20 at Wk 24 (р<0.0001). A significantly greater percentage of NTK-treated pts had ACR50/70, PsARC response, MDA at Wk 24 (Figure 1). By Wk 24 DAPSA significantly improved for NTK vs PBO. DAPSA remission was achieved by 36.08% and 13.40% in NTK and PBO arms, respectively (p=0.003). NTK was well tolerated. The most frequent AEs (≥3%) were lymphopenia, neutropenia, hypercholesterolemia, ALT increased, upper respiratory tract infection, systolic blood pressure increased, hyperglycemia, hyperbilirubinemia. Most AEs were mild to moderate. Severe treatment-related AEs were observed in 1.03% vs 2.06% for NTK and PBO, respectively. No treatment-related SAEs were reported. No anti-drug antibodies were detected.Table 1.Baseline demographics and disease severity characteristicsArmNTK (N=97)PBO (N=97)Age (years) *44.0 (11.66)43.1 (11.88)Male, n (%)52 (53.61)50 (51.55)PsA duration, mo*63.1 (73.12)68.2 (77.49)DAS28-CRP*4.62 (0.97)4.41 (1.11)DAPSA*32.19 (12.23)33.54 (15.98)TJC (66/68) *12.9 (9.97)12.0 (9.88)SJC (66/68) *7.0 (4.93)7.2 (7.18)MTX at baseline83 (85.6)83 (85.6)Previous PsA therapySulfasalazine, n (%)9 (9.28)11 (11.34)Leflunomide, n (%)4 (4.12)8 (8.25)Anti-TNFα, n (%)22 (22.68)17 (17.53)* mean (standard deviation); Mo=months, PsA=psoriatic arthritis, SJC=swollen joint count, TJC=tender joint count, DAS28=Disease Activity Score, MTX=methotrexate, CRP=C-reactive protein, DAPSA=Disease activity index for psoriatic arthritis, TNF=tumor necrosis factorFigure 1.Treatment response at Wk 24Conclusion:NTK is a well-tolerated monoclonal antibody, that provided sustained improvements in signs and symptoms of active PsA through 24 Wks of therapy.Table 2.Safety dataArmNTK (N=97)PBO (N=97)p-valueTreatment-related AEs12 (12.37)7 (7.22)0.2271Treatment-related SAEs0 (0)0 (0)1.002Treatment-related AEs (grade 3-4)1 (1.03)2 (2.06)1.002Local reactions0 (0)0 (0)-Grade 3-4 treatment-related AEsblood pressure increased1 (1.03)0(0)1.002lymphopenia0 (0)2 (2.06)0.4972n (%) are presented,1Pearson’s χ2test,2Fisher’s exact test; N=number of patients, AE=adverse event, SAE=serious adverse event, ALT=Alanine transaminaseAcknowledgments:This study was sponsored by JSC BIOCAD.Disclosure of Interests:Tatiana Korotaeva Consultant of: Pfizer, MSD, Novartis, AbbVie, Celgene, JSC BIOCAD, Janssen, UCB, Lilly and Novartis-Sandoz, Speakers bureau: Pfizer, MSD, Novartis, AbbVie, Celgene, JSC BIOCAD, Janssen, UCB, Lilly and Novartis-Sandoz, Inna Gaydukova Grant/research support from: JSC BIOCAD, Speakers bureau: Pfizer, Novartis, AbbVie, JSC BIOCAD, Сelgene, MSD, Sanofi, V Mazurov: None declared, Aleksey Samtsov Grant/research support from: JSC BIOCAD, Novartis, Eli Lilly, Johnson&Johnson, Celgene, Glenmark, Galderma, Sanofi, Vladislav Khayrutdinov Grant/research support from: Akrikhin, Alkoy, Belupo, JSC BIOCAD, Bosnaliejk, Verteks, Glenmark, Elfa, Leo Pharma, MSD, Novartis, Pfizer, Sun Pharma, Sanofi, Celgene, Pharmtec, AbbVie, Eli Lilly, Jadran, Janssen, Andrey Bakulev Grant/research support from: AbbVie, Eli Lilly, Pfizer, UCB, MSD, Novartis, Galderma, Celgene, Leo Pharma and Johnson&Johnson, JSC BIOCAD, Consultant of: Novartis, Celgene and Johnson&Johnson, Speakers bureau: AbbVie, Eli Lilly, Galderma, UCB, Novartis, Celgene and Johnson&Johnson, Muza Kokhan Grant/research support from: AbbVie, Eli Lilly, Pfizer, UCB, MSD, Novartis, Galderma, Celgene, Leo Pharma and Johnson&Johnson, JSC BIOCAD, Consultant of: Novartis, Celgene and Johnson&Johnson, Speakers bureau: AbbVie, Eli Lilly, Galderma, UCB, Novartis, Celgene and Johnson&Johnson, Alena Kundzer: None declared, Nikolaj Soroka Grant/research support from: JSC BIOCAD, Ekaterina Dokukina Employee of: JSC BIOCAD, Anna Eremeeva Employee of: JSC BIOCAD
Background:Psoriatic arthritis (PsA) is associated with multiple manifestations, resulting in reduced health-related quality of life (HR-QoL) of patients (pts). Netakimab (NTK) is a humanized anti-IL17A antibody approved for the treatment of moderate-to-severe plaque psoriasis.Objectives:To assess the impact of NTK on patient-reported outcomes (PROs) in active PsA pts, based on data of 24-week (wk) data from the ongoing PATERA study (NCT03598751).Methods:PATERA is an international double-blind, placebo-controlled clinical study. 194 eligible adult pts with PsA (CASPAR, 2006), with inadequate response to csDMARD or one TNFi, were randomized (1:1) to receive NTK 120 mg or placebo (PBO) at Wk 0, 1, 2, 4, 6, 8, 10, 14, 18, 22. Pts from PBO arm failed to achieve ACR20 (20% improvement of the American College of Rheumatology criteria) by Wk 16 were switched to NTK. PROs included changes from baseline (BL) in Work Productivity and Activity Impairment General Health (WPAI GH), 36-item Short Form Health Survey (SF-36), European Quality of Life Questionnaire (EQ-5D-5L), Dermatology Quality of Life Index (DLQI), Health assessment questionnaire disability index (HAQ-DI).Results:BL demographics and PsA characteristics were similar between treatment arms (Table 1). The proportion of pts with an improvement of ≥1 level in EQ-5D domains at Wk 24 (among pts who reported problems at BL) was higher in NTK arm compared to PBO (Figure 1). The assessment of physical disability showed positive dynamics in NTK arm: at Wk 24 mean change in HAQ-DI from BL was -0.6 for NTK vs -0.1 for PBO (p<0.0001). DLQI was assessed in pts with ≥3% body surface area involvement at BL (N=76 in NTK arm, N=72 in PBO arm). A greater reduction in DLQI was observed in NTK-treated pts (-11.4) compared to PBO-treated pts (-1.8) (p<0.0001). After 24 wks WPAI response for NTK was better than for PBO in all aspects, except work time missed due to PsA (Table 2). Positive dynamics were reported for both SF-36 components, however, the difference between NTK and PBO was not statistically significant. At Wk 24 mean change from baseline in SF-36 PCS in NTK arm was 10.4 vs 7.7 in PBO (p=0.29), mean change in SF-36 MCS was 6.4 vs 9.0 in the same arms, respectively (p=0.56).Table 1.BL demographics and PsA characteristicsArmNTK (N=97)PBO (N=97)Age (years)*44.0 (11.7)43.1 (11.9)Male, n (%)52 (53.6)50 (51.6)PsA duration, mo*63.1 (73.1)68.2 (77.5)HAQ-DI*1.15 (0.6)1.21 (0.6)DLQI*14.8 (6.5)13.9 (7.3)SF36 PCS*32.39 (9.5)31.10 (8.9)SF36 MCS*45.29 (10.7)46.04 (11.5)* mean (standard deviation), N=number of pts, mo=months, PsA=psoriatic arthritis, HAQ-DI=Health assessment questionnaire disability index, DLQI=Dermatology Quality of Life Index, SF36=36-item Short Form Health Survey, MCS=Mental Component Summary, PCS=Physical Component SummaryTable 2.WPAI change from BL at wk 24 (mean±standard deviation)ParameterNTKPBOAbsenteeism (%)-8.7±29.1N=60-9.1±31.8N=47Presenteeism (%)-22.1 ±22.1N=57-1.0±26.5N=42Overall work impairment (%)-18.6±21.8N=570.6±26.7N=42Activity impairment (%)-25.5±25.2N=96-5.4±29.1N=97N=number of pts in the analysis categoryFigure 1.Improvement in EQ-5D categoriesConclusion:NTK demonstrated rapid improvement in QoL, work productivity and physical function in pts with PsA.Acknowledgments:This study was sponsored by JSC BIOCAD.Disclosure of Interests:Tatiana Korotaeva Consultant of: Pfizer, MSD, Novartis, AbbVie, Celgene, JSC BIOCAD, Janssen, UCB, Lilly and Novartis-Sandoz, Speakers bureau: Pfizer, MSD, Novartis, AbbVie, Celgene, JSC BIOCAD, Janssen, UCB, Lilly and Novartis-Sandoz, Inna Gaydukova Grant/research support from: JSC BIOCAD, Speakers bureau: Pfizer, Novartis, AbbVie, JSC BIOCAD, Сelgene, MSD, Sanofi, V Mazurov: None declared, Aleksey Samtsov Grant/research support from: JSC BIOCAD, Novartis, Eli Lilly, Johnson&Johnson, Celgene, Glenmark, Galderma, Sanofi, Vladislav Khayrutdinov Grant/research support from: Akrikhin, Alkoy, Belupo, JSC BIOCAD, Bosnaliejk, Verteks, Glenmark, Elfa, Leo Pharma, MSD, Novartis, Pfizer, Sun Pharma, Sanofi, Celgene, Pharmtec, AbbVie, Eli Lilly, Jadran, Janssen, Andrey Bakulev Grant/research support from: AbbVie, Eli Lilly, Pfizer, UCB, MSD, Novartis, Galderma, Celgene, Leo Pharma and Johnson&Johnson, JSC BIOCAD, Consultant of: Novartis, Celgene and Johnson&Johnson, Speakers bureau: AbbVie, Eli Lilly, Galderma, UCB, Novartis, Celgene and Johnson&Johnson, Muza Kokhan Grant/research support from: AbbVie, Eli Lilly, Pfizer, UCB, MSD, Novartis, Galderma, Celgene, Leo Pharma and Johnson&Johnson, JSC BIOCAD, Consultant of: Novartis, Celgene and Johnson&Johnson, Speakers bureau: AbbVie, Eli Lilly, Galderma, UCB, Novartis, Celgene and Johnson&Johnson, Alena Kundzer: None declared, Nikolaj Soroka Grant/research support from: JSC BIOCAD, Ekaterina Dokukina Employee of: JSC BIOCAD, Anna Eremeeva Employee of: JSC BIOCAD
Background:Inflammatory back pain (IBP) is a common symptom of axial disease in patients with psoriatic arthritis (PsA). The reported prevalence of axial disease in patients with PsA is quite variable and must be taken into account while choosing treatment strategy. Netakimab (NTK) is an anti-interleukin-17A monoclonal antibody approved for psoriasis, ankylosing spondylitis, PsA in Russia and Belarus.Objectives:A subanalysis was aimed to investigate the ACR (American College of Rheumatology) 20/50/70 response rate in PsA patients with/without the axial disease, defined by the presence of IBP according to self-reported ASAS IBP criteria, 2009 at baseline.Methods:PATERA is an ongoing phase 3 international double-blind, placebo-controlled clinical study (NCT03598751). 194 adult patients with PsA (CASPAR criteria, 2006) with inadequate response to csDMARD or one TNFi, were randomly assigned to receive NTK 120mg or placebo at weeks 0,1,2,4,6,8,10,14,18,22. The ACR response was calculated in NTK-treated patients with IBP (IBP(+)) and NTK-treated patients without IBP (IBP(-)) according to self-reported ASAS IBP criteria, 2009. Patients with missing values for categorical variables were considered as non-responders in the analysis.Results:97 PsA patients (N=54 IBP(+), N=43 IBP(-)) received NTK. Both subpopulations were comparable in gender, age, and PsA activity at baseline. There were no significant differences in ACR20 achievement between the groups (Figure 1). The percentage of patients with ACR50 was significantly (p<0.05) higher in the IBP(-) subpopulation at weeks 4-20 (data not shown), but not at week 24 with 63% IBP(+) and 79% IBP(-) responders (p≥0.05). Similarly, IBP(+) patients had a lower frequency of ACR70 response (Figure 1).Conclusion:NTK is effective in PsA treatment irrespectively of the presence of axial disease. Both IBP(-) and IBP(+) subpopulations achieved ACR20/50/70 as well, however, the benefit in IBP(-) patients was more pronounced.Figure 1ACR response ratesAcknowledgements:This study was sponsored by JSC BIOCAD.Disclosure of Interests:Tatiana Korotaeva Speakers bureau: Abbvie, Biocad, Eli Lilly, Johnson & Johnson, Janssen, Novartis, Pfizer, UCB, Inna Gaydukova Speakers bureau: Abbvie, Biocad, Eli Lilly, MSD, Novartis, Pfizer, Sandoz, V Mazurov: None declared., Aleksey Samtsov: None declared., Vladislav Khayrutdinov: None declared., Andrey Bakulev: None declared., Alena Kundzer: None declared., Nikolaj Soroka: None declared., Anna Eremeeva Employee of: Biocad.
Cell differentiation affections substantiate the urgency of the problem related to studying mutual impact of primary or secondary endocrine pathology and hyperproliferative skin diseases. Psoriasis is one of the most demonstrative pathologies for this study for being a prevalent and genetically predetermined disease with a chronic and relapsing course characterized by increased proliferation of keratinocytes, abnormal differentiation process of epidermis cells, inflammatory and immune changes in derma, and dyshormonal disorders are among factors triggering the disease. The study involved 61 male patients. The study group (n = 43) comprised patients with circumscribed psoriasis vulgaris at the progression stage while the control group (n = 18) comprised healthy people. Blood concentration of such hormones as prolactin and cortisone was assessed by the immune-enzyme assay method. An increased cortisone concentration in patients suffering from psoriasis vs. control group was revealed. Psoriatic patients tend to have an increased prolactin level.
Background:PATERA is an ongoing phase 3 international double-blind, placebo-controlled clinical study of netakimab (NTK) in psoriatic arthritis (PsA) (NCT03598751). Netakimab (NTK) is an anti-interleukin-17A monoclonal antibody approved for psoriasis, ankylosing spondylitis, PsA in Russia and Belarus.Objectives:A subanalysis was performed to define the impact of NTK on PsA activity depending on the presence of axial disease: a subset of patients with inflammatory back pain (IBP) according to self-reported ASAS IBP criteria, 2009 (IBP(+) was compared to those without IBP (IBP(-)).Methods:194 eligible adult patients with PsA fulfilling the CASPAR criteria, with inadequate response to csDMARD or one TNFi, were randomly assigned to receive NTK 120mg or placebo at weeks 0,1,2,4,6,8,10,14,18,22. Patients with missing values for categorical variables were considered as non-responders in the analysis. For quantitative variables, missing values were replaced using the multiple imputation method.Results:97 PsA patients (N=54 IBP(+), N=43 IBP(-)) received NTK. Both subpopulations were comparable in gender, age and PsA activity at baseline. The treatment led to a pronounced decline in PsA activity in both subpopulations, significant differences between arms were observed only in DAPSA remission and very low disease activity (VLDA) at week 24 (Figure 1A). Changes from baseline in DAS28-CRP were consistent between IBP(+) and IBP(-) patients with a rapid decline during the first month with further improvement up to week 24 (Figure 1B). A similar trend was observed PsA-specific composite responder index (PSARC) (data not shown). A comparable percentage of IBP(+) and IBP(-) patients achieved PSARC at each timepoint of evaluation with 87% and 86% of responders respectively at week 24.Conclusion:NTK significantly improved PsA activity regardless of the presence of IBP.Figure 1.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-CRPAcknowledgements:This study was sponsored by JSC BIOCAD.Disclosure of Interests:Tatiana Korotaeva Speakers bureau: Abbvie, Biocad, Eli Lilly, Johnson & Johnson, Janssen, Novartis, Pfizer, UCB, Inna Gaydukova Speakers bureau: Abbvie, Biocad, Eli Lilly, MSD, Novartis, Pfizer, Sandoz, V Mazurov: None declared, Aleksey Samtsov: None declared, Vladislav Khayrutdinov: None declared, Andrey Bakulev: None declared, Alena Kundzer: None declared, Nikolaj Soroka: None declared, Anna Eremeeva Employee of: Biocad.
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