Background:From February 2015 to April 2020, patients with active psoriatic arthritis under treatment with ustekinumab in routine clinical care in Germany were included into the prospective, multi-center non-interventional study SUSTAIN.Objectives:Here, we present final data from SUSTAIN including final week 160 on long term efficacy and safety of ustekinumab treatment, quality of life and further patient reported outcomes.Methods:In SUSTAIN, 337 patients were treated with ustekinumab according to routine clinical care at 75 centers for 160 weeks with documentation intervals at week 0 and 4 and then every 12 weeks. The collected data included demographics, number of swollen and tender joints, tender entheses, amount of skin symptoms (BSA and PASI), patient reported outcome concerning disease activity and pain, Health Assessment Questionnaire (HAQ), quality of life (SF-12), sleep quality (VAS), satisfaction with therapy of patient and physician, safety (adverse events [AE]/serious adverse events [SAE]), pharmacoeconomic aspects, number of patients with „Minimal Disease Activity“ (MDA) and number of patients with MDA at week 28 und 52. For this analysis, final data of all 337 patients of all documented visits were analyzed.Results:The visit at week 4 was documented for 31 patients, at week 28 for 282, at week 52 for 216, and at week 160 for 129 of the 337 patients. At baseline, the patients had a mean age of 53.6 years (22-85) and 192 (57%) were female. The patients’ mean BMI was 29.6 kg/m2 (18.6-52). 54.3 % of the patients had at least one TNF inhibitor as prior medication. 54.1 % of the patients used MTX as concomitant medication. At time of inclusion, 73.3% of the patients showed arthritis at small and 52.2% at large joints. 16.9% showed spinal involvement and 13.1% enthesitis. In the course of the treatment, the number of tender joints improved from a mean of 10.0 (CI 95% 8.6/11.3) at baseline to 4.1 (3.2/4.9) at week 28, 3.6 (2.7/4.6) at week 52 and 1.0 (0.6/1.4) at week 160. Number of swollen joints improved from 4.1 (3.4/4.9) at baseline to 1.8 (1.2/2.3) at week 28, to 1.3 (0.8/1.8) at week 52 and to 0.4 (0.2/0.6) at week 160. BSA declined from a mean of 15.6% (rage from 0 to 80.0%) at baseline to 5.2% (0 to 60%) at week 28, to 3.0% (0 to 45.0%) at week 52 and to 1.7 (0 to 35%) at week 160. PASI declined from a mean of 7.3 (range from 0 to 43.0) at baseline to 1.7 (0 to 24.8) at week 28, to 1.3 (o to 28.5) at week 52 and to 0.5 (0 to 3.2) at week 160. Efficacy of the therapy with ustekinumab was assessed as “very good” or “good” by 85.3% of the treating physicians at week 52 and by 94.1% at week 160. The patients assessed the efficacy as “very good” or “good” by 82.8% at week 52 and by 89.8% at week 160. At the end of the study, 96 SAEs have been documented, of which only 16 were related to ustekinumab. All in all, safety of therapy with ustekinumab was assessed as “very good” or “good” by 99% of the treating physicians after 52 weeks and by 99.2 % after 160 weeks. The patients assessed the safety as “very good” or “good” by 97.5% at week 52 and by 100% at week 160.Conclusion:The non-interventional study SUSTAIN showed relevant disease improvements and good safety with an outstanding high therapy satisfaction in patients with active psoriatic arthritis treated with ustekinumab. Treatment effect was observed as early as after 4 weeks. The treatment effects and satisfaction sustained up end of documentation at week 160 in daily practice life.Disclosure of Interests:None declared.
THU0128 Do biological dmards prevent long term articular damage by rheumatoid arthritis in routine clinical care?
