Background:Ustekinumab has been efficacy and safety for psoriatic artritis in clinical trials.Objectives:To assess effectiveness, by means of drug persistence analisys, and safety of ustekinumab in patients with psoriastic arthritis in Biobadaser.Methods:BIOBADASER is the Spanish registry of biological drugs of the Spanish Society of Rheumatology and the Spanish Medicines Agency. We identified patients aged 18 years or more with psoriatic arthritis on Ustekinumab. A descriptive analysis was performed.The persistence of ustekinumab therapy was calculated with a Kaplan-Meier curve and was compared with the persistence of anti-TNF, according to line treatment. Log Rank test was used to establish a comparison. Adverse events occurring with ustekinumab are described according to year treatment.Results:One hundred and twelve patients were on ustekinumab. Most of them were on their second or third line treatment: 53.57% more than one biological therapy (BT), 19.64% second BT, 26.79% were naïve for BT. Most of them were on 45 mg dose: 88.24%. Median duration of disease at Ustekinumab initiation was 10.1 SD 7.2 years; 69.23% had peripheral arthritis; 45.24% had obesity and 39.29% were overweight; 40,6% were on prednisone and 59.82% on DMARD. The cause of discontinuation of treatment was mainly inefficacy (82.61%) and less common an adverse event (6.52%). The probability of persistence of treatment with ustekinumab was 0.83 (95% CI 0.63-0.92) at year 1, 0.79 (0.58-0.90) at year 2 and 0.79 (0.58-0.9) at year 3 when ustekinumab was prescribed as the first line treatment. The persistence decrease when ustekinumab was prescribe as a second and third treatment: being 0.53 (0.27-0.73) the first year, 0.46 (0.22-0.67) the second year and 0.46 (0.22-0.67) as a second line treatment and 0.58 (0.44-0.70) the first year, 0.33 (0.17-0.50) the second year and 0.33 (0.17-0.50) the third year as a third line treatment.The persistence was similar to anti-TNF treatment, according to line treatment. Adverse events were mainly mild (97.83%) and occurred the first year of treatment. Most of the adverse events were classified as “infections and infestations” (36.96%).Conclusion:The persistence of ustekinumab was high, being 83% at the end of the first year on treatment and 79% the second and the third year of treatment. The persistence of ustekinumab was higher when if it was the first line treatment compared as if it was used as the second o third BT option. The persistence of Ustekinumab is similar to the persistence of anti-TNF treatments in all the analyzed treatment lines (no statistically differences were found). Adverse events occurred mainly during the first year treatment. They were mainly mild adverse events and the frequency decreased within the second and third year of treatment.References:[1]Treatment with ustekinumab in a Spanish cohort of patients with psoriasis and psoriatic arthritis in daily clinical practice.Almirall M, Rodriguez J, Mateo L, Carrascosa JM, Notario J, Gallardo F. Clin Rheumatol. 2017 Feb;36(2):439-443;[2]Minimal disease activity in patients with psoriatic arthritis treated with ustekinumab: results from a 24-week real-world study.Napolitano M, Costa L, Caso F, Megna M, Scarpa R, Balato N, Ayala F, Balato A. J Clin Rheumatol. 2018 Oct;24(7):381-384;[3]Minimal Disease Activity and Patient-Acceptable Symptom State in Psoriatic Arthritis: A Real-World Evidence Study With Ustekinumab.Queiro R, Brandy A, Rosado MC, Lorenzo A, Coto P, Carriles C, Alperi M, Ballina J. Actas Dermosifiliogr. 2018 Jun 28;[4]An analysis of Drug Survival, Effectiveness, and Safety in Moderate to Severe Psoriasis Treated With Ustekinumab: An Observational Study of 69 Patients in Routine Clinical Practice.Salgüero Fernández I, Gil MH, Sanz MS, Gullón GR;Disclosure of Interests:None declared
Algorithmic prediction of failure modes in healthcare
