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POS1060 (2022)
CHANGES IN DISEASE ACTIVITY AND PATIENT-REPORTED OUTCOMES IN PSORIATIC ARTHRITIS PATIENTS TREATED WITH IXEKIZUMAB IN A REAL-WORLD US COHORT
J. Birt1, W. Tillett2, C. Cavanaugh3, Y. Jung3, A. Vadhariya1, S. Ross4, J. Paulus3, A. T. Sprabery4, E. Lubrano5
1Eli Lilly and Company, Value, Evidence, and Outcomes, Indianapolis, United States of America
2Royal National Hospital for Rheumatic Disease, Department of Rheumatology, Bath, United Kingdom
3OM1, OM1, Boston, United States of America
4Eli Lilly and Company, Medical Affairs, Indianapolis, United States of America
5Università Degli Studi del Molise, 4.Academic Rheumatology Unit, Dipartimento Di Medicina e Scienze, Campobasso, Italy

Background: Ixekizumab (IXE), an IL-17A inhibitor, has demonstrated efficacy in clinical trials 1-3 but real-world effectiveness (RWE) data are limited. 4


Objectives: To 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.


Methods: This 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.


Results: The 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%).

Demographic and Clinical Characteristics by Therapy Status

All 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)
Sex Female 1,108 (61.1%) 909 (61.2%) 199 (60.9%)
Male 704 (38.9%) 576 (38.8%) 128 (39.1%)
Charlson Comorbidity Index Mean (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)
BMI Underweight: <18.5 10 (0.6%) 10 (0.7%) 0 (0.0%)
Normal weight: 18.5-24.9 210 (12.2%) 172 (12.2%) 38 (12.1%)
Overweight: 25-29.9 455 (26.5%) 379 (27.0%) 76 (24.2%)
Obese: >= 30 1,045 (60.8%) 845 (60.1%) 200 (63.7%)
Missing 92 79 13
Domains of PsA: Psoriasis Yes 1,490 (82.2%) 1,222 (82.3%) 268 (82.0%)
No 322 (17.8%) 263 (17.7%) 59 (18.0%)
Domains of PsA: Enthesitis Yes 510 (28.1%) 409 (27.5%) 101 (30.9%)
No 1,302 (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.


Conclusion: In 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.


REFERENCES:

[1]Mease PJ. Ann. Rheum. Dis. 2017;76(1):79-87

[2]Nash P. Lancet . 2017;389(10086):2317-2327

[3]Mease PJ. Ann. Rheum. Dis. 2020;79(1):123-131

[4]Berman J. Biologics . 2021 Nov 18;15:463-470


Disclosure of Interests: Julie Birt Shareholder of: Shareholder of Eli Lilly and Company, Employee of: Employee of Eli Lilly and Company, William Tillett Speakers bureau: Abbvie, Amgen, Celgene, Eli-Lilly, Janssen, MSD, Novartis,, Pfizer, UCB, Consultant of: Abbvie, Amgen, Celgene, Eli-Lilly, Janssen, MSD, Novartis, Pfizer, UCB, Grant/research support from: Abbvie, Amgen, Celgene, Eli-Lilly, Janssen, UCB, Cristi Cavanaugh: None declared, Yoojin Jung: None declared, Aisha Vadhariya Shareholder of: Shareholder of Eli Lilly and Company, Employee of: Employee of Eli Lilly and Company, Sarah Ross Shareholder of: Shareholder of Eli Lilly and Company, Employee of: Employee of Eli Lilly and Company, Jess Paulus: None declared, Aubrey Trevelin Sprabery Shareholder of: Shareholder of Eli Lilly and Company, Employee of: Employee of Eli Lilly and Company, Ennio Lubrano: None declared

Citation: , volume 81, supplement 1, year 2022, page 851
Session: Psoriatic arthritis - treatment (POSTERS only)