Patient's Global Assessment as an Outcome Measure for Psoriatic Arthritis in Clinical Practice: A Surrogate for Measuring Low Disease Activity?

Objective.To assess the low disease activity (LDA) in a group of patients with psoriatic arthritis (PsA) receiving antitumor necrosis factor-α (TNF-α) by using the patient's global assessment (PtGA) in clinical practice, and to compare PtGA with minimal disease activity (MDA) and other outcome measures.Methods.Patients with PsA classified by the ClASsification for Psoriatic ARthritis (CASPAR) criteria and consecutively admitted to an outpatient clinic dedicated to biologic therapy were assessed during their routine followup. The primary outcome measure was the proportion of patients achieving a PtGA ≤ 20 at 4-, 8-, and 12-month followups. Secondary outcome measures included the proportion of patients achieving MDA and other outcome measures. Correlation of PtGA with MDA and other process and outcome measures were also performed.Results.During the period of observation, 124 patients were evaluated. PtGA ≤ 20 was achieved in 25.7% at 4 months, 48.9% at 8 months, and 65.3% at 12 months of followup. The percentage of PtGA ≤ 20 statistically improved throughout the 3 timepoint assessments and it was statistically correlated to MDA. A significant correlation with the Disease Activity index for PSoriatic Arthritis (DAPSA), Bath Ankylosing Spondylitis Disease Activity Index, and Health Assessment Questionnaire was also observed. MDA, DAPSA, and Disease Activity Score at 28 joints with C-reactive protein remission were achieved at 12 months in 64%, 36%, and 71% of patients, respectively.Conclusion.PtGA can estimate the LDA status and could be considered as a surrogate of outcome measures for the assessment of global disease activity in patients with PsA receiving anti-TNF therapy during routine clinical practice. These data suggest that PtGA might be used in outpatient settings, being a simple, reliable, and not time-consuming instrument

Identification of the Minimal Disease Activity Domains Achieved Based on Different Treatments in Psoriatic Arthritis

Introductionthe aim of this work is to characterize which minimal disease activity (MDA) domains are mainly achieved, based on different treatments, in psoriatic arthritis (PsA) patients. Moreover, the association between MDA achievement and the different treatment groups was assessed.MethodsWe conducted a cross-sectional analysis of two longitudinal PsA groups. Inclusion criteria were: age & GE; 18 years, PsA diagnosis, stable treatment for at least 6 months. patients were grouped depending on the therapy: group 1: non-steroidal anti-inflammatory drugs (NSAIDs)/cyclooxygenase 2 inhibitors (COX2i)/steroids, group 2: conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), group 3: tumor necrosisfFactor & alpha; inhibitors (TNFi), group 4: interleukin inhibitors (IL)12-23i or IL-23i, group 5: IL-17i, group 6: phosphodiesterase 4 inhibitors (PD4i). For each group, the achieved domains based on therapy were assessed. Multivariate logistic regression analysis was performed to assess the association between the treatment groups and the MDA achievement.resultsA total of 220 patients were enrolled, and MDA was achieved in 45.8% of them. In all treatment groups, the first MDA domains achieved were: body surface area & LE; 3, swollen joint count & LE; 1 and Leeds Enthesitis Index & LE; 1, while MDA domains less frequently achieved were Patient Global Assessment (PtgA) & LE; 2 cm and pain on visual analogue scale & LE; 1.5 cm. The logistic regression analysis showed higher odds ratios for the achievement of the MDA in those patients in groups 3 and 4.ConclusionsIn each treatment group, MDA domains less frequently achieved were PtGA and pain, suggesting that "patient-driven domains" are still an unmet need.Due to the study design and the low number of patients in some groups, it is not possible to clearly define which MDA domain was achieved or not based on treatment; however, it seems that some differences could be present. If larger and prospective studies confirm our preliminary results, we could move toward a personalized/domain treatment approach in PsA.ConclusionsIn each treatment group, MDA domains less frequently achieved were PtGA and pain, suggesting that "patient-driven domains" are still an unmet need.due to the study design and the low number of patients in some groups, it is not possible to clearly define which MDA domain was achieved or not based on treatment; however, it seems that some differences could be present. If larger and prospective studies confirm our preliminary results, we could move toward a personalized/domain treatment approach in PsA

Occult axial involvement in patients with psoriatic arthritis mutilans: a case report.

We present the case of a patient with psoriatic arthritis (PsA) mutilans and occult axial involvement. The patient had suffered from PsA mutilans for more than a decade, with severe residual articular damage, but had been in clinical remission for years. Clinical axial involvement was never reported; however, magnetic resonance imaging of the sacroiliac joints, performed for other reasons, documented active inflammation and damage even without clinical symptoms. These findings corroborated the hypothesis that axial involvement could be asymptomatic, subclinical and, furthermore, underdiagnosed or even occult in patients with PsA mutilans, in which cases it should be carefully evaluated

Management of Axial Disease in Patients With Psoriatic Arthritis: An Updated Literature Review Informing the 2021 GRAPPA Treatment Recommendations

Objective. Axial involvement in patients with psoriatic arthritis (PsA) is a common subset of this condition, but a unanimous definition has yet to be established. It has been defined by using different criteria, ranging from the presence of at least unilateral grade 2 sacroiliitis to those used for ankylosing spondylitis (AS), or simply the presence of inflammatory low back pain (IBP). Our aim was to identify and evaluate the efficacy of therapeutic interventions for treatment of axial disease in PsA.Methods. This systematic review is an update of the axial PsA (axPsA) domain of the treatment recommen-dations project by the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).Results. The systematic review of the literature showed that new biologic and targeted synthetic dis-ease-modifying antirheumatic drug classes, namely interleukin (IL)-17A and Janus kinase inhibitors, could be considered for the treatment of axPsA. This would be in addition to previously recommended treatments such as nonsteroidal antiinflammatory drugs, physiotherapy, simple analgesia, and tumor necrosis factor inhibitors. Conflicting evidence still remains regarding the use of IL-12/23 and IL-23 inhibitors.Conclusion. Further studies are needed for a better understanding of the treatment of axPsA, as well as vali-dated outcome measures

Case report of polymyalgia rheumatica in a male patient with three different neoplasms treated with pembrolizumab.

In this manuscript we aim to describe a particular case of a 63 years-old man who developed three different malignancies (one was a rare case of breast cancer) among nearly five years. In particular, for the diagnosis of melanoma, he was treated with pembrolizumab, a PD-1 inhibitor. After few months of treatment with pembrolizumab, the patient reported the onset of musculoskeletal symptoms such as inflammatory pain at the shoulders and morning stiffness, with raised CRP and ESR and imaging evidence of bursitis and tenosynovitis. A polymyalgia-like syndrome was diagnosed. Understanding if these manifestations are linked to the use of pembrolizumab or to a paraneoplastic syndrome, and how to manage the patient, was the real challenge

Sex-associated and gender-associated differences in the diagnosis and management of axial spondyloarthritis: addressing the unmet needs of female patients

Emerging evidence suggests that axial spondyloarthritis (axSpA) should not be seen as a predominantly male disease, as the non-radiographic form occurs with roughly equal frequency in women and men. However, men and women experience this disease differently. The purpose of this review is to highlight sex-associated and gender-associated differences in the patient's journey through the diagnosis and management of axSpA, in order to increase the awareness about the unmet needs of female axSpA patients. Female patients experience a longer diagnostic delay compared with men, possibly due to the different pattern of clinical presentations across genders. Therefore, it is crucial to sensitise physicians to pay attention and identify the red flags of axSpA in women and promote early referral to a rheumatologist. Women with a diagnosis of axSpA experience greater limitations in physical function, although they have less structural spinal damage compared with men. Women tend to have less adherence and a lower response to treatment, so more gender-oriented data are needed about drugs used for axSpA, especially biological disease-modifying antirheumatic drugs. Lifestyle factors have a strong impact on the disease course. Interventions regarding physical activity, smoking cessation and diet should be communicated to the patients, with particular attention to the gender-related cultural background. Patients of childbearing age living with axSpA should be engaged in a discussion about reproductive health, in terms of preservation of fertility, management of pregnancy and delivery and use of biologic drugs during pregnancy and breastfeeding

Remission, low disease activity and improvement of pain and function in psoriatic arthritis patients treated with IL-12/23 and IL-17 inhibitors. A multicenter prospective study

The development of new biologic and targeted synthetic DMARDs can lead to good disease control. The aim of the present study was to assess the rate of remission and low disease activity, and the improvement of pain and function, in psoriatic arthritis (PsA) patients treated with new anti-IL-12/23 and anti-IL-17 biologic agents. A prospective 6-month study was performed. Patients fulfilling the CASPAR criteria for PsA that started ustekinumab, secukinumab and ixekizumab were enrolled and prospectively followed in a setting of clinical practice. Patients were considered in minimal disease activity (MDA), when they met at least 5/7 of the criteria previously defined. DAPSA score ≤4 was also evaluated as a remission criterion. Pain on VAS, PtGA and HAQ were also assessed in all patients. Patients achieving MDA were compared to non-MDA to identify outcome predictive factors. Of the 70 patients treated with ustekinumab, secukinumab and ixekizumab, at baseline, no patients were in MDA or had a DAPSA score ≤4. Ten patients (14.2%) were lost during the follow-up. After 6 months, MDA was achieved in 22 (31.4%) patients. DAPSA≤4 was achieved in 17 (24.2%) patients. Significant improvement in pain, PtGA and HAQ was also found. Patients naïve to anti-TNF treatment achieved more frequently MDA compared to anti-TNF-experienced patients. Male sex, high levels of CRP and absence of comorbidities were found to be predictors of MDA. In our prospective observational study, MDA was achieved in 31.4% and DAPSA remission in 24.2% of patients treated with inhibitors of IL-12/23 and IL-17, thus making this target achievable in PsA patients treated with these drugs

PsABIOnd study and eDaily substudy design: long-term effectiveness and safety of guselkumab and IL-17 inhibitors in routine clinical practice in patients with psoriatic arthritis

Introduction: Randomised clinical studies in psoriatic arthritis (PsA) do not always reflect patients in routine clinical practice. Large-scale data from routine practice are needed to better understand drug persistence, effectiveness and long-term safety of therapeutic agents. Methods: PsABIOnd is an international, prospective, observational study designed to collect long-term routine care data in patients with PsA who receive guselkumab (an interleukin-23 [IL-23] inhibitor) or an interleukin-17 (IL-17) inhibitor. Adult patients (≥ 18 years) with a confirmed diagnosis of PsA who are starting guselkumab or any approved IL-17 inhibitor as a first, second, third or fourth line of PsA treatment and who provide written informed consent will be eligible to participate. Participants will be followed for a maximum of 36 months (+3 months) from the start of treatment. Study visits will occur in line with the standard of care, approximately every 6 months, plus an additional visit at 3 months after the start of treatment. eDaily by PsABIOnd - aneHealth substudy, will document the impact of these treatments on wellbeing and symptoms in a subgroup of participants over a 24-week (+4 weeks) observation period on treatment. Planned Outcomes: The primary objective of PsABIOnd is to evaluate treatment persistence with guselkumab and IL-17 inhibitors. Data sources will include validated electronic patient-reported outcomes (ePROs) and physician-completed assessments. Safety data will be collected through reporting adverse events. The eDaily by PsABIOnd substudy will use wearable and digital technologies for continuous activity and sleep monitoring, and frequent patient eDiary and ePRO collection to provide a more detailed and comprehensive picture of PsA. Trial Registration: ClinicalTrials.gov identifier: NCT05049798