ARE THERE ANY DIFFERENCES IN THE EFFECTIVITY AND SAFETY OF CERTOLIZUMAB PEGOL IN PATIENTS WITH PSORIATIC ARTHRITIS ACCORDING THEIR GENDER?

Background: Gender-related biochemical, hormonal and psychological factors could play an important role in the response to TNF blocker therapy in psoriatic arthritis (PsA). Scarce data are available analyzing differences in effectiveness and safety of the antiTNFs, and none in particular with Certolizumab Pegol (CZP) according to the gender. Objectives: To evaluate the influence of the gender in the effectiveness and safety of CZP in the routine clinical setting in PsA patients. Methods: Observational, national and muticentric cohort (approved by local ethical committee), PsA patients treated with CZP according to routine clinical practice were studied for 12 months. Clinical and disease characteristics and disease activity between gender were compared. Safety analysis: adverse events and withdrawn. Results: 347 PsA patients were analyzed. No statistical differences were found between women and men at baseline in demographics, clinical variables, except for previous biologic treatment and ESR ( Table 1 ). In both genders, a statistical significant decreased was observed after 1 year of CZP treatment in the following variables: DAS28(CRP); SJC; TJC; PGA (patient global ssesment);% patients with enthesitis, dactilytis and nail disease; but with no differences between females and males. Variables that influence the response at 12 months are: disease duration, CRP and TJC at baseline. Drug survival of CZP was 80.1%, and no differences were observed in gender. Adverse events related to CZP were observed in 9.5% and 19.9% withdrawn treatment: 12.4% due to lack of effectiveness, 4.0% due to intolerance and 3.5% other reasons. Conclusion: CZP has shown to be effective and safe in PsA patient after a year of treatment in clinical practice regardless patient’s gender. Abstract aB0749 Table 1 Baseline demographic, clinical and disease activity characteristics. Demographic variables Female Male Gender, n (%) 196 (56.5) N=347 151 (43.5) N=347 Age, median (min-max), years 48.5(22.3;81.1) N=188 50.5 (22.0;78.0) N=137 No smoking, n (%) 137 (79.2) N=173 79 (56.8) N=139 Disease characteristics Disease duration, mean (Q1-Q3) 6.5 (1.8-8.7) N=188 6.9 (1.2-10.0) N=137 Presence of HLAB27 28 (20.3) N=138 13 (13.0) N=100 Previous biologics· 0· 1· ≥2 N=15537 (23.9)67 (43.2)51 (32.9) N=12448 (38.7)42 (33.9)34 (27.4) Disease activity TJC (28 joints), mean (Q1-Q3) 7.3 (4.0-10.0) N=167 6.5 (3.0- 8.0) N=125 SJC (28 joints), mean (Q1-Q3) 5.2 (2.0-8.0) N=156 4.8 (2.0-6.0) N=116 PtGA (VAS), mean (Q1-Q3) 7.0 (6.0-8.0) N=195 6.8 (6.0-8.0) N=150 PhGA (VAS), mean (Q1-Q3) 6.2 (5.0-8.0) N=193 6.1 (5.0-7.0) N=150 CRP (mg/L), mean (Q1-Q3) 10.1 (1.0-14.0) N=195 9.4 (0.9-11.4) N=151 ESR (mm/h), mean (Q1-Q3) 24.8 (8.8-37.3) N=90 16.6 (5.0-21.3) N=58 Abstract aB0749 Table 2. CZP effectiveness at 1 year of treatment Basal 3 months 12 months F M F M F M DAS28 (CRP); mean (SD) 4.7 (0.9) 4.5 (0.8) 3.9 (0.9) 3.9 (1.0) 3.7 (1.0) 3.4 (1.0) TJC; mean (SD) 7.3 (5.1) 6.5 (4.4) 5.2 (4.3) 5.1 (4.3) 4.4 (4.3) 4.0 (4.3) SJC; mean (SD) 5.2 (3.8) 4.8 (3.5) 3.8 (3.1) 3.9 (3.3) 3.6 (3.1) 3.7 (3.4) Enthesitis, n (%)* 38 (21.3) 35 (25) 30 (16.9) 26 (18.6) 12 (9.8) 8 (9.8) Dactlylitis, n (%)* 48 (26.4) 48 (34.8) 27 (14.8) 31 (22.5) 7 (5.6) 10 (12.5) Presence of nail disease, n (%)* 21 (24.7) 28 (38.4) 17 (20.0) 25 (34.2) 5 (9.8) 10 (25.0) Disclosure of interests: Rosa García : None declared, Manuel Fernandez-Prada: None declared, arantxa Conesa: None declared, Jose Campos Esteban: None declared, aNA URRUTICOECHEA-ARANA: None declared, alejandro Olive: None declared, SILVIA PAREDES Speakers bureau: Bristol, Roche, amgen, Pfiser, abbvie, lilly, UCB, Delia Taverner Speakers bureau: amgen, pfiser, Bristol, Lilly, Roche, Carlos Gonzalez Consultant for: Celgene, Gilead, Janssen, Merk, Novartis, Pfizer, Speakers bureau: Celgene, Roche, UCB DOI: 10.1136/annrheumdis-2019-eular.8143Citation: Ann Rheum Dis, volume 78, supplement 2, year 2019, page A1840Session: Psoriatic arthritis (Scientific Abstracts)