Ab0749 are There Any Differences in the Effectivity and Safety of Certolizumab Pegol in Patients With Psoriatic Arthritis According Their Gender?

Abstract

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 Safety analysis: adverse events and withdrawn.Results:347 PsA patients were analyzed.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 Adverse events related to CZP were observed in 9.5% and 19.9% withdrawn treatment: 12.4% due to lack of effectiveness, 4.0% due to intolerance and 3.5% other reasons.Conclusion:CZP has shown to be effective and safe in PsA patient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 1Baseline demographic, clinical and disease activity characteristics. Demographic variables Female Male Gender, n (%)196 (56.5) N=347151 (43.5) N=347Age, median (min-max), years48.5(22.3;81.1) N=18850.5 (22.0;78.0) N=137No smoking, n (%)137 (79.2) N=17379 (56.8) N=139 Disease characteristics Disease duration, mean (Q1-Q3)6.5 (1.8-8.7) N=1886.9 (1.2-10.0) N=137Presence of HLAB2728 (20.3) N=13813 (13.0) N=100Previous biologics· 0· 1· ≥2N=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=1676.5 (3.0- 8.0) N=125SJC (28 joints), mean (Q1-Q3)5.2 (2.0-8.0) N=1564.8 (2.0-6.0) N=116PtGA (VAS), mean (Q1-Q3)7.0 (6.0-8.0) N=1956.8 (6.0-8.0) N=150PhGA (VAS), mean (Q1-Q3)6.2 (5.0-8.0) N=1936.1 (5.0-7.0) N=150CRP (mg/L), mean (Q1-Q3)10.1 (1.0-14.0) N=1959.4 (0.9-11.4) N=151ESR (mm/h), mean (Q1-Q3)24.8 (8.8-37.3) N=9016.6 (5.0-21.3) N=58Abstract 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)3...

Sex-Specific Differences in Patients With Psoriatic Arthritis: A Systematic Review

“…33 In total, 3 studies reported nonsignificant differences, 19,30,34 and 1 study did not give a P value. 16 Coates et al Where reported (12 studies), disease duration between the sexes was similar. The largest difference was observed in Nas et al, 19 where the mean disease duration was 7.5 (SD 6.8) years for men and 10.2 (SD 9.1) years for women (P = 0.023).…”

“…Of the included studies, 11 were prospective cohort or observational studies, [13][14][15][16][17][18][19][20][21][22][23] including 1 post hoc analysis of a prospective observational study. 15 In total, 5 included studies were retrospective observational studies, [24][25][26][27][28] and 9 were cross-sectional studies.…”