POS1060 CHANGES IN DISEASE ACTIVITY AND PATIENT-REPORTED OUTCOMES IN PSORIATIC ARTHRITIS PATIENTS TREATED WITH IXEKIZUMAB IN A REAL-WORLD US COHORT

Abstract

BackgroundIxekizumab (IXE), an IL-17A inhibitor, has demonstrated efficacy in clinical trials1-3 but real-world effectiveness (RWE) data are limited.4ObjectivesTo describe changes in disease activity and patient-reported outcomes (PROs) at 6 and 12 months follow-up among psoriatic arthritis (PsA) patients initiating IXE in a routine clinical setting.MethodsThis retrospective cohort study included patients from the OM1 PsA Registry (OM1, Boston, MA), a linked electronic medical record and administrative claims dataset with over 50,000 patients. Eligible patients had ≥1 prescription for IXE (first = index), were ≥18 years old at index, had ≥1 diagnosis code for PsA in the 12 months before or on index, and had ≥12 months of baseline and ≥6 months of follow-up data as of June 2021. For patients with baseline and follow-up measures available, changes in Clinical Disease Activity Index (CDAI), PROs, and other clinical outcomes from baseline to 6 and 12 months were described. For patients on IXE monotherapy, change in CDAI score from baseline to 6 and 12 months was assessed using mixed effects linear models adjusted for age, sex, and baseline CDAI score.ResultsThe study population included 1,812 patients with a mean age of 53.7 years (Table 1). Psoriasis was present in 82% and enthesitis in 28%. Over 60% of patients were obese, and the mean Charlson Comorbidity Index was 1.3. Most patients (84%) had prior treatment with a biologic disease-modifying antirheumatic drug (bDMARD) and 40% with a targeted synthetic DMARD (tsDMARD). The mean number of bDMARDs and tsDMARDs used during all available prior history was 2.3 and 1.1, respectively. The most common prior bDMARDs were secukinumab (n=428, 24%) and adalimumab (n=245, 14%).Table 1.Demographic and Clinical Characteristics by Therapy StatusAll Patients(N=1,812)Monotherapy(N=1,485)Combination Therapy(N=327)Age (years)Mean (s.d.)53.7 (12.2)53.9 (12.3)52.9 (11.7)Median (Q1-Q3)55 (46-62)55 (46-62)54 (45-61)SexFemale1,108 (61.1%)909 (61.2%)199 (60.9%)Male704 (38.9%)576 (38.8%)128 (39.1%)Charlson Comorbidity IndexMean (s.d.)1.3 (1.6)1.3 (1.6)1.5 (1.7)Median (Q1-Q3)1 (0-2)1 (0-2)1 (0-2)BMIUnderweight: <18.510 (0.6%)10 (0.7%)0 (0.0%)Normal weight: 18.5-24.9210 (12.2%)172 (12.2%)38 (12.1%)Overweight: 25-29.9455 (26.5%)379 (27.0%)76 (24.2%)Obese: >= 301,045 (60.8%)845 (60.1%)200 (63.7%)Missing927913Domains of PsA: PsoriasisYes1,490 (82.2%)1,222 (82.3%)268 (82.0%)No322 (17.8%)263 (17.7%)59 (18.0%)Domains of PsA: EnthesitisYes510 (28.1%)409 (27.5%)101 (30.9%)No1,302 (71.9%)1,076 (72.5%)226 (69.1%)Of patients with a baseline CDAI score, 61% had moderate or severe disease activity. For all patients, CDAI scores improved (decreased) by an average of 3.4 and 3.7 points at 6 and 12 months, respectively, from a baseline mean of 15.4. All disease activity measures and PROs improved from baseline to 6 and 12 months (Figure 1). In patients persistent with IXE, 35.3% and 33.7% were in CDAI remission or low disease activity at 6 and 12 months after initiation, respectively. For IXE monotherapy users (82% of patients), at baseline, patients had a mean CDAI of 14.3 (n=131) and 15.1 (n=105) for the 6 and 12 month analyses, respectively. Adjusted mean changes in CDAI from baseline to 6 months (-3.6 points, p < 0.0001) and 12 months (-4.9 points, p < 0.0001) were statistically significant.ConclusionIn this cohort of PsA patients with multiple prior b/tsDMARD failures, improvements in disease activity and PROs were observed at 6 and 12 months after initiating treatment with IXE. Improvements were observed in patients overall and in the monotherapy subgroup. More real-world research on IXE and other bDMARDs are important to understand the effect of treatment choices on clinical and PROs in both bDMARD-naive and experienced PsA patients.