Efficacy of ustekinumab in biologic-naïve patients with psoriatic arthritis by prior treatment exposure and disease duration: data from PSUMMIT 1 and PSUMMIT 2

Abstract

ObjectiveTo evaluate the efficacy of ustekinumab by prior treatment exposure and disease duration in tumour necrosis factor inhibitor (TNF)-naïve patients with psoriatic arthritis (PsA) in the PSUMMIT 1 and PSUMMIT 2 studies.MethodsIn the phase 3, randomised, placebo-controlled PSUMMIT 1 and PSUMMIT 2 studies, adults with active PsA for ≥6 months despite conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and/or non-steroidal anti-inflammatory drugs (NSAIDs) (PSUMMIT 1) or csDMARDs, NSAIDs and/or anti-TNF agents (PSUMMIT 2) were enrolled. Patients were randomised to subcutaneous injections of placebo, ustekinumab 45 mg or ustekinumab 90 mg at weeks 0 and 4 and every 12 weeks. Efficacy was assessed at week 24 using the American College of Rheumatology criteria and 28-joint count disease activity score using C reactive protein (DAS28-CRP); radiographical progression, enthesitis, and dactylitis were also assessed in this post hoc analysis.ResultsA total of 747 patients were included; all 747 were TNF-naïve, of which, 179 were methotrexate-naïve and TNF-naïve, and 146 were all csDMARD-naïve and TNF-naïve. At week 24, greater proportions of ustekinumab-treated patients had ≥20%/50%/70% improvement in American College of Rheumatology criteria (ACR20/ACR50/ACR70) responses, DAS28-CRP response and DAS28-CRP remission versus placebo in all three prior-treatment populations, with similar differences between treatment groups. Greater proportions of ustekinumab-treated patients also had complete resolution of enthesitis and dactylitis at week 24 across the three prior-treatment populations. Mean changes from baseline in total van der Heijde-Sharp Score at week 24 were generally smaller for ustekinumab-treated patients versus placebo but were statistically significant only in the full TNF-naïve population. Response rates for ACR20/ACR50/ACR70 were similar for TNF-naïve patients with PsA durations of <1 year, ≥1 to <3 years, and ≥3 years.ConclusionUstekinumab-treated patients demonstrated greater clinical response at week 24 compared with placebo regardless of prior treatment exposure and PsA disease duration.

Biologic Treatment Algorithms for Moderate-to-Severe Psoriasis with Comorbid Conditions and Special Populations: A Review

“…In two phase III RCTs (PSUMMIT 1 AND 2; n = 546 psoriasis and PsA/747 total PsA), ustekinumab resulted in decreased radiologic progression compared with placebo [ 20 ]. Additionally, more patients receiving ustekinumab 45 or 90 mg experienced complete resolution of enthesitis and dactylitis by week 24 compared with placebo [ 20 ].…”

“…In two phase III RCTs (PSUMMIT 1 AND 2; n = 546 psoriasis and PsA/747 total PsA), ustekinumab resulted in decreased radiologic progression compared with placebo [ 20 ]. Additionally, more patients receiving ustekinumab 45 or 90 mg experienced complete resolution of enthesitis and dactylitis by week 24 compared with placebo [ 20 ]. Analysis of the BIOPURE (Biologic Apulian) registry ( n = 160) showed longer 12-month drug survival of ustekinumab and better clinical outcomes in TNFi-naïve patients with PsA [ 21 ].…”

Psoriatic Arthritis With Dactylitis: A Case Report and Concise Review of Treatment Options

“…Table 1 depicts various clinical trials depicting the efficacy of biologic agents in patients with dactylitis. Several clinical trials have shown significant benefits in dactylitis [14][15][16][17][18][19][20]. However, dactylitis was not the main outcome measure in any of these trials.…”

Клиническое Значение Энтезитов При Спондилоартритах: От Патофизиологии К Лечению (Обзор Литературы)

“…The Ustekinumab, which inhibits the IL-12/23 р40, demonstrated its effect in the enthesitis treatment of 47 % PsA patients with peripheral and axial lesions, compared to placebo (16 %) [61]. A recent study confirms that the Ustekinumab is effective despite a previous csDMARD use and disease duration [62]. The Guselkumab, which inhibits the IL-23 p19, also demonstrated promising results at the Phase 3 of PsA enthesitis treatment trials.…”