THU0280 Early and long-term treatment response as well as high tolerability lead to high treatment satisfaction of a therapy with ustekinumab in patients with active psoriatic arthritis – results of the non-interventional study sustain
Authors: J. Wendler, E. Movshovich, J. Behrens, F. Hamann, P. Wagener, F. Behrens
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> SUSTAIN is a prospective, multi-centre non-interventional study in Germany to observe long term efficacy and safety, quality of life and further patient reported outcomes in patients with active psoriatic arthritis under treatment with ustekinumab in routine clinical care. <h3>Methods</h3> In this study nearly 400 patients were planned to be documented at 75 centres for 160 weeks with documentation intervals at week 0 and 4 and then every 12 weeks. The treatment with Ustekinumab is according to the label (Stelara<sup>®</sup>). Besides demographic data, the following data will be documented: 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), number of patients with MDA at week 28 und 52. For the present second interim analysis baseline data of all 336 patients and results of the documented visits up to week 76 were analysed. <h3>Results</h3> For the present analysis 336 patients (57% women) at 75 centres were observed. The visit at week 4 was documented for 290 patients, at week 16 for 305 patients, at week 28 for 262 patients, and at week 76 for 100 patients. At baseline, the patients had a mean age of 54 years<sup><sup>22–85</sup></sup> and BMI of 30 kg/m².<sup><sup>19–52</sup></sup> 53.9% of the patients had as prior medication a TNF inhibitor and stopped because of inadequate response. Only 38% of the patients used MTX as concomitant medication. The patients showed arthritis at small (73.2%) and/or large (52.1%) joints, spinal involvement (16.7%) and enthesitis (13.1%). Number of tender joints improved from a mean of 10.0 (CI 95% 8.6/11.3) at baseline to 6.4 (5.4/7.3) at week 4 and 2.1 (1.4/2.9) at week 76. Number of swollen joints improved from 4.1 (3.4/4.9) at baseline to 2.6 (2.1/3.1) at week 4 and to 0.7 (0.4/1.0) at week 76. Efficacy of the therapy with ustekinumab was assessed as "very good" or "good" by 76.2% of the treating physicians at week 16 and by 89.9% at week 76. The patients assessed the efficacy as "very good" or "good" by 71.2% at week 16 and by 90.7% at week 76. Until data cut off point (32 months after study start), 67 SAEs have been documented, of which only 13 were related to ustekinumab. All in all, safety of therapy with ustekinumab was assessed as "very good" or "good" by 96.0% of the treating physicians after 16 weeks and by 98% after 76 weeks. The patients assessed the safety as "very good" or "good" by 93.3% at week 16 and by 98.0% at week 76. <h3>Conclusions</h3> The non-interventional study SUSTAIN showed relevant improvements with high therapy satisfaction and good safety in patients with active psoriatic arthritis treated with Ustekinumab after 4 weeks up to 76 weeks in daily practice life. <h3>Disclosure of Interest</h3> J. Wendler Consultant for: Janssen-Cilag GmbH,, E. Movshovich Employee of: Janssen-Cilag GmbH,, J. Behrens Employee of: Janssen-Cilag GmbH,, F. Hamann: None declared, P. Wagener: None declared, F. Behrens: None declared