Ustekinumab Is Rapid-Acting and Is an Effective Long-Term Treatment for Patients with Active Psoriatic Arthritis: Real-World Evidence from the Non-interventional SUSTAIN Study

Jörg Wendler; Nils Damann; Marit Röcken; Verena Teicher; Maximilian Schuier; Frank Hamann; Holger Schwenke; Maren Sieburg; Frank Behrens

doi:10.1007/s40744-022-00484-3

Ustekinumab Is Rapid-Acting and Is an Effective Long-Term Treatment for Patients with Active Psoriatic Arthritis: Real-World Evidence from the Non-interventional SUSTAIN Study

Rheumatol Ther. 2022 Oct;9(5):1435-1450. doi: 10.1007/s40744-022-00484-3. Epub 2022 Sep 6.

Authors

Jörg Wendler¹, Nils Damann², Marit Röcken³, Verena Teicher³, Maximilian Schuier³, Frank Hamann⁴, Holger Schwenke⁵, Maren Sieburg⁶, Frank Behrens⁷

Affiliations

¹ Rheumatologische Schwerpunktpraxis, Erlangen, Germany.
² Janssen-Cilag, Neuss, Germany. NDamann@its.jnj.com.
³ Janssen-Cilag, Neuss, Germany.
⁴ Gemeinschaftspraxis für Internistische Rheumatologie, Leipzig, Germany.
⁵ Rheumatologisches MVZ, Dresden, Germany.
⁶ Rheumatologische Facharztpraxis, Magdeburg, Germany.
⁷ Rheumatologie und Fraunhofer Institut IM-TMP, Goethe-Universität, Frankfurt, Germany.

Abstract

Introduction: Psoriatic arthritis (PsA) is a chronic, progressive disease that places a significant burden on patients and healthcare systems. The SUSTAIN study collected real-world evidence on long-term effectiveness, impact on quality of life, and safety of ustekinumab treatment for PsA.

Methods: SUSTAIN was a prospective, non-interventional study conducted in Germany. Patients with active PsA received ustekinumab for 160 weeks in routine clinical care, with assessments at baseline, week 4, and every 12 weeks thereafter. This analysis focuses on patients who remained in SUSTAIN until week 160.

Results: Of 337 patients enrolled, 129 were documented at week 160, of which 123 (95.3%) had received previous PsA medication, including biologics. Decreases from baseline to week 4 were observed for tender joint count (TJC, 8.0 to 5.8) and swollen joint count (SJC, 4.5 to 3.1); these decreases continued to week 28 and were maintained to week 160 (1.0 and 0.4, respectively). Similarly, skin assessments in patients with PsA and psoriasis revealed improvement at week 4, which continued to week 28, with a sustained effect until week 160. Similar patterns of response were observed for patient-assessed pain, sleep quality, and health scores. Improvements in TJC, SJC, Psoriasis Area and Severity Index, and affected body surface area were observed irrespective of the number of prior biologic therapies used. Minimal disease activity was achieved by 36 (31.9%) patients at week 28, and by 38 (33.6%) at week 52. Ustekinumab-related adverse events (AEs) and serious AEs were reported in 61 (47.3%) and 4 (3.1%) patients, respectively. At week 160, 100% of patients assessed ustekinumab tolerability as good or very good.

Conclusions: In a real-world setting, patients with active PsA who received ustekinumab until 160 weeks (3 years), including those who received prior biologic therapies, had a rapid onset of effect and sustained response to treatment, with high tolerability.

Trial registration: PEI NIS No. 290.

Keywords: Long-term efficacy; Psoriatic arthritis; Real world; Tolerability; Ustekinumab.