The “Climb” Towards  Minimal Disease Activity in Psoriatic Arthritis

Lubrano, Ennio; Scriffignano, Silvia; Perrotta, Fabio Massimo

doi:10.1007/s40744-021-00343-7

Cited by 12 publications

(6 citation statements)

References 19 publications

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“…Our findings that disease activity based on TJC, pain, and PtGA measurements often limit the achievement of composite outcomes are generally consistent with published studies identifying pain, PtGA, skin disease, and tender joints as the most common unmet criteria in patients failing to achieve MDA/VLDA treatment targets [ 16 , 26 , 27 ]. However, in contrast to other studies [ 3 , 16 , 26 ], achievement of the skin disease criterion was not a limiting factor in attaining MDA/VLDA for most patients in DISCOVER-1 and DISCOVER-2.…”

Section: Discussionsupporting

confidence: 90%

Guselkumab provides sustained domain-specific and comprehensive efficacy using composite indices in patients with active psoriatic arthritis

et al. 2022

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Objectives To evaluate the efficacy of guselkumab for the treatment of active PsA utilizing composite indices. Methods Data were pooled from the phase 3 DISCOVER-1 (n = 381) and DISCOVER-2 (n = 739) studies. In both studies, patients were randomized 1:1:1 to subcutaneous guselkumab 100 mg every 4 weeks (Q4W); guselkumab 100 mg at week 0, week 4, then Q8W; or placebo Q4W with crossover to guselkumab 100 mg Q4W at week 24. Composite indices used to assess efficacy through week 52 included Disease Activity Index for Psoriatic Arthritis (DAPSA), Psoriatic Arthritis Disease Activity Score (PASDAS), minimal disease activity (MDA), and very low disease activity (VLDA). Through week 24, treatment failure rules were applied. Through week 52, non-responder imputation was used for missing data. Results Greater proportions of guselkumab- than placebo-treated patients achieved DAPSA low disease activity (LDA) and remission, PASDAS LDA and VLDA, MDA, and VLDA at week 24 vs placebo (all unadjusted P < 0.05). At week 52, in the guselkumab Q4W and Q8W groups, respectively, response rates were as follows: DAPSA LDA, 54.2% and 52.5%; DAPSA remission, 18.2% and 17.6%; PASDAS LDA, 45.3% and 41.9%; PASDAS VLDA, 16.9% and 19.5%; MDA, 35.9% and 30.7%; and VLDA, 13.1% and 14.4%. In the placebo-crossover-to-guselkumab group, response rates for all composite indices increased after patients switched to guselkumab, from week 24 through week 52. Conclusion Treatment with guselkumab provided robust and sustained benefits across multiple PsA domains through 1 year, indicating that guselkumab is an effective therapy for the diverse manifestations of PsA. Trial registration NCT03162796; NCT03158285

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Section: Discussionsupporting

confidence: 90%

Guselkumab provides sustained domain-specific and comprehensive efficacy using composite indices in patients with active psoriatic arthritis

et al. 2022

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“…Unlike the real-world analysis of patients treated with infliximab, golimumab, or ustekinumab [ 5 ], the present study demonstrated that guselkumab-treated patients achieved minimal SJC, PASI, and enthesitis on average within 16–20 weeks, and approximately 70% of patients had achieved near remission in these domains at week 100. The identification of different trajectories of Pt Pain, PtGA, and HAQ-DI in the present analysis is consistent with previous studies demonstrating that patient-reported MDA criteria are achieved less frequently in PsA patients [ 5 , 11 ]. Furthermore, this finding is also consistent with reports showing that time to achieve low disease activity or remission in patient-reported outcomes was considerably longer compared with physician-assessed criteria, such as SJC in patients with rheumatoid arthritis [ 38 ].…”

Section: Discussionsupporting

confidence: 92%

“…In a real-world analysis of patients with PsA who received infliximab, golimumab, or ustekinumab, the MDA criteria that were least likely to be achieved were Pt Pain, PtGA, and PASI [ 5 ]. Of note, criteria for patient-reported domains of MDA may be less frequently achieved [ 5 , 11 ], owing to comorbidities associated with systemic inflammatory conditions [ 12 ], including fibromyalgia and obesity, that may indirectly contribute to unmet MDA domain criteria.…”

Section: Introductionmentioning

confidence: 99%

Continuous improvement through differential trajectories of individual minimal disease activity criteria with guselkumab in active psoriatic arthritis: post hoc analysis of a phase 3, randomized, double-blind, placebo-controlled study

Coates,

Rahman,

Mease

et al. 2024

BMC Rheumatol

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Background To explore the trajectory of, and factors contributing to, achievement of individual criteria of minimal disease activity (MDA) in patients with active psoriatic arthritis (PsA) treated with guselkumab. Methods The Phase 3, randomized, placebo-controlled DISCOVER-2 study enrolled adults (N = 739) with active PsA despite standard therapies who were biologic/Janus kinase inhibitor-naive. Patients were randomized 1:1:1 to guselkumab 100 mg every 4 weeks; guselkumab 100 mg at week 0, week 4, then every 8 weeks; or placebo. In this post hoc analysis, patients randomized to guselkumab were included and pooled (N = 493). Longitudinal trajectories of achieving each MDA criterion through week 100 were derived using non-responder imputation. Time to achieve each criterion was estimated with Kaplan-Meier analysis. Multivariate regression for time to achieve each criterion (Cox regression) and achievement at week 100 (logistic regression) was used to identify contributing factors. Results Continuous improvement across all MDA domains was shown over time. ~70% of patients achieved near remission in swollen joint count (SJC), Psoriasis Area and Severity Index (PASI), and enthesitis through week 100. Median times to achieve individual criteria differed significantly (p < 0.0001), with SJC ≤ 1 (20 weeks), PASI ≤ 1 (16 weeks), and ≤ 1 tender entheses (16 weeks) being faster than patient-reported criteria (pain ≤ 15 mm, patient global assessment of arthritis and psoriasis ≤ 20 mm, Health Assessment Questionnaire-Disability Index ≤ 0.5) and tender joint count ≤ 1. Higher baseline domain scores, older age, worse fatigue, and increased body mass index were significant predictors of longer time to achieve minimal levels of disease activity assessed via patient-reported criteria. Conclusions Substantial proportions of guselkumab-treated patients achieved individual MDA criteria, each showing continuous improvement through week 100, although with distinct trajectories. Median times to achieve physician-assessed MDA criteria were significantly faster compared with patient-driven criteria. Identification of modifiable factors affecting the time to achieve patient-reported criteria has the potential to optimize the achievement and sustainability of MDA in the clinic via a multidisciplinary approach to managing PsA, involving both medical and lifestyle interventions. Trial registration number NCT03158285. Trial registration date May 16, 2017.

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“…Among the various clinical manifestations of this multifaceted syndrome [2], we found that there is an unequal distribution of some clinical features such as dactylitis, enthesitis, and psoriasis onset age. On the other side, we found that TJC, SJC, disease activity level, and even the absence of achievement of MDA differed between the two sexes, being more prevalent in females [25]. These results are in keeping with previous data, reinforcing that the management of PsA between the two sexes is still un unmet need [26].…”

Section: Discussionsupporting

confidence: 89%

Psoriatic Arthritis in Males and Females: Differences and Similarities

et al. 2023

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Objective: To assess any differences and similarities in psoriatic arthritis (PsA) between sexes. Any possible differences of psoriasis and its potential impact on disease burden between sexes with PsA were also evaluated. Methods: Cross-sectional analysis of two longitudinal PsA cohorts. The impact of psoriasis on the PtGA was evaluated. Patients were stratified in four groups based on BSA. The median PtGA was then compared between the four groups. Moreover, a multivariate linear regression analysis was performed in order to evaluate associations between PtGA and skin involvement, split by sexes. Results: We enrolled 141 males and 131 females: PtGA, PtPnV, tender, swollen joint count, DAPSA, HAQ-DI, PsAID-12 were statistically significant higher in females (p B 0.05). PASS ''yes'' was deemed more in males than in females and BSA was higher in males. MDA was present more in males than females. When the patients were stratified on BSA, median PtGA was not different between males and females with BSA = 0. Instead, in females with BSA [ 0, a higher PtGA was observed compared to males with BSA [ 0. There was not a statistically significant association between skin involvement and PtGA at linear regression analysis, even if a trend seems to be present in female. Conclusions: Psoriasis is more present in males, but it seems to be related to a worse impact in females. In particular, a possible role of psoriasis as an influencing factor the PtGA was found. Moreover, female PsA patients tended to have more disease activity, worse function, and higher disease burden.

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The “Climb” Towards Minimal Disease Activity in Psoriatic Arthritis

Cited by 12 publications

References 19 publications

Guselkumab provides sustained domain-specific and comprehensive efficacy using composite indices in patients with active psoriatic arthritis

Guselkumab provides sustained domain-specific and comprehensive efficacy using composite indices in patients with active psoriatic arthritis

Continuous improvement through differential trajectories of individual minimal disease activity criteria with guselkumab in active psoriatic arthritis: post hoc analysis of a phase 3, randomized, double-blind, placebo-controlled study

Psoriatic Arthritis in Males and Females: Differences and Similarities

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