Key messages
- Ci sono scarse evidenze real-world a lungo termine sul confronto dell’efficacia tra ixekizumab (IXE) e adalimumab (ADA).
- Il presente studio ha confrontato pattern di trattamento real-world di pazienti affetti da psoriasi trattati con IXE e ADA in un periodo di 24 mesi negli Stati Uniti d’America.
- I pazienti trattati con IXE hanno avuto miglior aderenza e persistenza terapeutiche e un minor rischio di interruzione del trattamento rispetto a quelli che hanno utilizzato ADA nei 24 mesi.
Abstract
Background
There is a paucity of long-term real-world evidence comparing the effectiveness of ixekizumab (IXE) and adalimumab (ADA). We compared real-world treatment patterns of IXE-treated and ADA-treated patients with psoriasis over 24 months in the United States.
Methods
A retrospective observational study was conducted using IBM Watson Health MarketScan®; databases. Adult patients with psoriasis having ≥1 claim for IXE or ADA from March 1, 2016 – October 31, 2019 were identified. Inverse probability of treatment weighting (IPTW) was used to address cohort imbalances. Cox proportional hazards models were used to estimate the risks of non-persistence, discontinuation, and switching. Logistic regression was used to estimate odds of high adherence. Persistence, adherence, discontinuation, reinitiation, and dosing and switching rates were also analyzed.
Results
The final cohorts comprised 475 IXE users and 3159 ADA users over 24 months. IXE users demonstrated higher adherence (36.3% vs 28.8%; p <;0.001) and persistence rates (35.2% vs 28.8%; p = 0.004), and a lower discontinuation rate (59.1% vs 65.3%; p = 0.007) compared to ADA users. IXE users had a higher likelihood of being treatment-adherent compared to ADA users (OR = 1.52, 95% CI: 1.24-1.87), a lower risk of non-persistence (HR = 0.84, 95% CI: 0.75-0.95), and a lower risk of discontinuation (HR = 0.83, 95% CI: 0.74-0.94), respectively. Switching rates were similar in both groups (31.2% vs 30.0%; p = 0.608).
Methods
149 patients were enrolled in the induction period (Weeks 0–12); patients randomised to either placebo (PBO) or Ixekizumab (IXEQ2W); most had GPSIS-Impact scores of ≥3 (moderate-to-very high), nearly one-third of patients had GPSIS-Avoidance score of 5 (always avoid sexual activity due to GenPs). At Week 12, 93% of patients (PBO: n = 65; IXE Q2W: n = 74) entered the open-label treatment period wherein all patients received IXE 80 mg every 4 weeks (Q4W) until Week 52, with initial PBO randomised patients receiving a 160 mg IXE starting dose. Dosing could be increased if necessary to achieve or maintain satisfactory disease control.
Results
Patients treated with IXE achieved persistent improvements in HRQoL, as measured by DLQI (0,1) and multiple domains of SF-36, and in the sexual impact of GenPs, at Week 12; these improvements persisted through Week 52. In the group that received IXE in both periods (IXE/IXE), the proportion of patients with GPSIS-Avoidance response persisted through Week 52, with 80% (n = 24/30) achieving GPSIS-Avoidance (1,2). Upon switching from PBO to IXE, GPSIS-Avoidance responses rapidly increased from 26% (n = 9/35) (Week 12) to 72% (n = 21/29) (Week 16) and 79% (n = 23/29) (Week 52). Upon switching from PBO to IXE, GPSIS-Impact response rapidly increased from 53% (n = 9/171 ) (Week 12) to 94% (15/16) (Week 16) and persisted through Week 52 (93%, n = 13/14). GPSIS-Impact (1,2) responses were numerically higher in the PBO/IXE group during the open-label treatment period. In the IXE/IXE population, 47% of patients achieved a DLQI (0,1) at Week 12 that persisted through Week 52 (Fig. 1c). DLQI item 9 (0,1) was achieved by 85% of IXE/IXE patients at Week 52. 51% of patients in the PBO/IXE group achieved DLQI (0,1) at Week 52, and 94% of patients achieved DLQI item 9 (0,1) at Week 52.
At Week 12, IXE treatment resulted in significantly greater mean change from baseline in six SF-36 domains,9 and the physical component summary (PCS; Table 1). Upon switching to IXEQ4W, the mean change from baseline for all SF-36 domains and both component summary scores increased from Week 12 to Week 52 in the PBO/IXE group. In the IXE/IXE group, improvements observed at Week 12 generally persisted through Week 52 but were numerically lower.
Conclusion
IXE users had better treatment adherence and persistence, and a lower risk of discontinuation compared to ADA users over 24 months. There was no difference in the risk of switching between IXE and ADA. J Drugs Dermatol. 2022;21(4):399-407. doi:10.36849/JDD.6336.