Long-Term Efficacy, Safety and Drug Survival of Ustekinumab in a Spanish Cohort of Patients with Moderate to Severe Plaque Psoriasis

Abstract

Objective: To investigate the efficacy and safety of ustekinumab in clinical practice and the influence of several variables on response rates as well as on drug survival. Methods: Retrospectively collected efficacy and safety data of a cohort of 67 consecutive patients treated with ustekinumab for moderate to severe psoriasis for at least 28 weeks and a maximum of 3 years. Drug survival was analyzed by the Kaplan-Meier method with log-rank test. Results: PASI75 response rates were numerically higher in patients treated with 45 mg and patients naïve to tumor necrosis factor (TNF)-blocking agents, at all time points. Drug survival was not significantly affected by any variable. Conclusion: Male sex, weight >100 kg, obesity, and previous failure of one or more TNF inhibitors were associated with a diminished response to treatment. Obesity or previous exposure to anti-TNF agents was not associated with a diminished drug survival in this Spanish cohort.

Etanercept, adalimumab, and ustekinumab in psoriasis: analysis of 209 treatment series in Austria

“…The estimated one-year drug survival was 57 % for etanercept, 72 % for adalimumab, and 84 % for ustekinumab. These differences were statistically signifi cant and in line with other reports, thus favoring adalimumab and ustekinumab over etanercept [ 19,20,24,25,29,31 ] . Although -following the example of most other authors -we used Kaplan Meier survival functions to estimate drug survival, we deem it necessary to point out that the results have to be interpreted with caution, as a potential bias due to different study entry times cannot be ruled out [ 32 ] .…”

“…To test for possible predictors, we used linear regression modeling after verifying the test assumptions by running regression diagnostics, using graphical methods to check for infl uential data, residual normality, and homoscedasticity, as well as variance infl ation factor/tolerance to check for multicollinearity. The variable selection was based on published literature [ 20,24,25 ] .…”

Body mass index predicts discontinuation due to ineffectiveness and female sex predicts discontinuation due to side-effects in patients with psoriasis treated with adalimumab, etanercept or ustekinumab in daily practice: a prospective, comparative, long-t

“…1 In order to optimize psoriasis treatment strategies in clinical practice, several real-world studies have assessed drug survival of individual biologics, [2][3][4][5][6][7][8] compared drug survival between biologics [9][10][11][12][13][14][15][16][17][18] or searched for clinical characteristics that might predict the discontinuation of biological agents. [2][3][4][5][6][7]9,11,12 Drug survival is a comprehensive measure of effectiveness and safety and the preferences of both the patient and physician, and reflects the probability a patient will stay on the drug over time. 19 Although drug survival is becoming an increasingly popular outcome measure in biological treatment of psoriasis, still only a limited number of daily-practice studies are available that used prospective data from multiple centres to compare biological agents.…”

Effectiveness End Points in Real-World Studies on Biological Therapies in Psoriasis: Systematic Review with Focus on Drug Survival

“…Clinical outcomes (mainly PASI) were reported in 75% of prospective studies [27, 39, 47-53], in about 50% of prospective registries [20, 24, 54-61] and retrospective studies [29, 30, 32, 34, 37, 62-70], and in no retrospective administrative databases/claims. Drug survival of biological therapies was reported in over 60% of prospective registries [14, 20, 21, 24, 25, 31, 54, 57, 71-74], retrospective studies [18, 19, 22, 23, 26, 29, 30, 32, 34, 37, 38, 68, 70, 75-77] and administrative databases/claims [28, 35, 36, 40-42, 46], and less frequently (33%) in prospective studies [27, 33, 52, 78]. Subanalyses on reasons of discontinuation, such as switching, dose augmentation, or biological therapy restarting, were scanty.…”