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AB0792 (2020)
NETAKIMAB IMPROVES PATIENT-REPORTED OUTCOMES IN PATIENTS WITH PSORIATIC ARTHRITIS: RESULTS FROM A RANDOMIZED DOUBLE-BLIND PHASE 3 TRIAL (PATERA)
T. Korotaeva1, I. Gaydukova2, V. Mazurov2, A. Samtsov3, V. Khayrutdinov3, A. Bakulev4, M. Kokhan5, A. Kundzer6, N. Soroka7, E. Dokukina8, A. Eremeeva8
1Nasonova Research Institute of Rheumatology, Moscow, Russian Federation
2Mechnikov North-Western State Medical University, St-Petersburg, Russian Federation
3Kirov Military Medical Academy, St-Petersburg, Russian Federation
4Razumovsky Saratov State Medical University, Saratov, Russian Federation
5Ural Research Institute of Dermatovenerology and Immunopathology, Ekaterinburg, Russian Federation
6Healthcare Institution Municipal Clinical Hospital No. 1, Minsk, Belarus
7Scientific and Practical Center of Surgery, Transplantology and Hematology, Minsk, Belarus
8JSC BIOCAD, St-Petersburg, Russian Federation

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).

BL demographics and PsA characteristics

Arm NTK (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 Summary

WPAI change from BL at wk 24 (mean±standard deviation)

Parameter NTK PBO
Absenteeism (%) -8.7±29.1 N=60 -9.1±31.8 N=47
Presenteeism (%) -22.1 ±22.1 N=57 -1.0±26.5 N=42
Overall work impairment (%) -18.6±21.8 N=57 0.6±26.7 N=42
Activity impairment (%) -25.5±25.2 N=96 -5.4±29.1 N=97

N=number of pts in the analysis category

Improvement in EQ-5D categories


Conclusion: 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

Citation: Ann Rheum Dis, volume 79, supplement 1, year 2020, page 1691
Session: Psoriatic arthritis (Abstracts Accepted for Publication)