The effectiveness and safety of ixekizumab in psoriasis patients under clinical practice conditions: A Spanish multicentre retrospective study

Abstract

The objective of the study was to evaluate efficacy and safety of ixekizumab in psoriasis patients under clinical practice conditions. Observational, retrospective, multicentre study that included patients with ixekizumab from March 2017 to March 2019. ≥ 90% reduction in the Psoriasis Area and Severity Index (PASI 90) and absolute PASI <2 were the parameters used to assess treatment response. Adverse events (AEs) were collected. Of the 301 patients included, 111 were women (36.9%), mean age was 48.5 (±13.5) years. Mean baseline PASI score was 13.5 (±7.7). More than half of the patients (68.5%) had received at least one biological drug before. At 3 months, 208 (76.5%) patients achieved PASI <2 and 156 (57.3%) PASI 90. At 12 months, 130 (73.4%) patients achieved absolute PASI <2 and 104 (58.7%) PASI 90. Multivariate analysis revealed that prior use of biologics was influential in achieving PASI <2 at both 3 and 12 months (OR 2.82, P = .006; OR 9.51, P < .001, respectively). Sixty-five patients (21.59%) exhibited at least one AE, injection site reaction was the most

Ixekizumab treatment in patients with moderate‐to‐severe plaque psoriasis in a real‐world clinical setting

“…with RCTs, but PASI90 response rates (86.1%) were higher at week 16. Age, sex, duration of psoriasis, and baseline PASI scores of the patients in our cohort were similar to those in other studies [15][16][17][18][19][20][21] bio-naive (19.3%) and bio-experienced (80.3%) patients at week 12 were higher in the bio-experienced group (76.1% vs. 67.7%) without significant difference. 23 Interestingly, most of the RWD has shown that a prior biologic agent treatment failure negatively affects ixekizumab response.…”

“…23 Interestingly, most of the RWD has shown that a prior biologic agent treatment failure negatively affects ixekizumab response. 15,17,18,20 Our findings support earlier RWD that biologic-naive patients had a higher PASI 90 response rate (90.9% vs. 61.5%) at week 16. Participation of biologic-naive patients (80.3%) in our study is similar to the study conducted by Damiani et al 16 ; however, the aforementioned study did not an- Obesity was the most common comorbidity in our patient cohort.…”

“…Besides, predictors of PASI responses were identified by recording the fast action of the drug at week 4 and its effectiveness at week 16. Although, there have been RCTs 7 and several real-world studies [15][16][17][18][19][20][21] on the efficacy and safety of ixekizumab, there has not been any RWD reported from Turkey as per our investigation. Unsurprisingly, our results showed both similarities and dissimilarities with RCTs and other RWD analyses indicating the genetic heterogeneity among the population included in each study.…”

“…These results are better than the outcomes seen in RCTs 7 and the previously published single or multi-centered RWD from Spain, Italy, and Canada. 15,[17][18][19][20] Integrated analysis of three-phase III psoriasis studies (UNCOVER-1,-2, and −3) with ixekizumab demonstrated high response rates at week 12 with nearly 90% and 70% of the patients achieving PASI75 and PASI90, respectively. 22 Our study showed similar PASI75 response rates (92.1%)…”

Effectiveness and safety of guselkumab for the treatment of psoriasis in real‐world settings at 24 weeks: A retrospective, observational, multicentre study by the Spanish Psoriasis Group

“…Clinical trial data are obtained under conditions distinct from those found in routine clinical practice. Authors studying the realworld use of various drugs have observed that the patient population in clinical practice has different characteristics to that of clinical trials 8,9 and, in some cases, the outcomes observed in registry data are different from those reported in clinical trials. 10 For this reason, data on the use of a drug in a real-world setting help clinicians to predict how it will work in the patients they attend in their practice.…”