Development of an Instrument for Patient Self-assessment in Psoriatic Arthritis.

OBJECTIVE: Due to the recent pandemic caused by the coronavirus disease 2019 (COVID-19), in-person scheduled rheumatology appointments in many countries have been reserved for urgent cases only. Here we report the development of a multidimensional, patient-completed disease assessment tool for use in psoriatic arthritis (PsA). METHODS: A focus group development and education method was used, followed by a paired observation design to assess feasibility and validity. The Psoriatic Arthritis Disease Activity Score (PASDAS) was used as the basis for the clinical assessments, but elements of this tool were modified during the focus group sessions. RESULTS: A preliminary tool assessed tender and swollen joint counts, enthesitis, dactylitis, area of skin involved by psoriasis, and scores for global disease activity, fatigue, and spinal pain. In parallel assessments, good agreement was found between subject and healthcare professional (HCP) assessors, although overall disease activity was low. CONCLUSION: A self-assessment tool for disease activity in PsA has been developed in conjunction with patients, demonstrating generally good agreement between patients and HCPs; however, further validation is needed before it can be recommended for clinical practice.

A clinical and radiographic comparison of patients with psoriatic arthritis from different ethnic backgrounds.

OBJECTIVES: There are few papers concerning ethnic differences in disease expression in PsA, which may be influenced by a number of genetic, lifestyle and cultural factors. This article aims to compare clinical and radiographic phenotypes in people of South Asian (SA) and North European (NE) origin with a diagnosis of PsA. METHODS: This was a cross-sectional observational study recruiting patients of SA and NE origin from two hospitals in a well-defined area in the North of England. RESULTS: A total of 58 SA and 48 NE patients were recruited. SA patients had a more severe clinical phenotype with more tender (median 5 vs 2) and swollen (median 1 vs 0) joints, more severe enthesitis (median 3 vs 1.5), more patients with dactylitis (24% vs 8%), more severe skin disease (median PASI 2.2 vs 1) and worse disease activity as measured by the composite Psoriatic Arthritis Disease Activity Score (mean 4.5 vs 3.6). With regards to patient-completed measures, SA patients had worse impact with poorer quality of life and function (mean HAQ 0.9 vs 0.6; mean PsAQoL 10.8 vs 6.2; mean 36-item short form physical component score 33.5 vs 38.9). No significant differences in current MTX and biologics use were found. CONCLUSIONS: SA patients had a worse clinical phenotype and worse impact of disease than NE patients. Further studies are needed to confirm and explore the reasons behind these differences.

Systematic literature review of non-topical treatments for early, untreated (systemic therapy naïve) psoriatic disease: a GRAPPA initiative.

BACKGROUND: Psoriatic disease (PsD) is a complex systemic disorder with cutaneous and musculoskeletal manifestations. Current evidence on pharmacological interventions, effective across the spectrum of clinical manifestations of early, systemic treatment-naïve PsD, is limited. This review aims to appraise such evidence. METHODS: This systematic review examined seven patient-intervention-comparator-outcome research questions to address the efficacy of the interventions on the following: across the spectrum of clinical manifestations PsD activity; peripheral arthritis; dactylitis; spondylitis; enthesitis; skin; and nails. Early PsD was defined as a disease duration of ≤2 years, except for studies investigating outcomes restricted to the skin. Eligible references were clinical trials or well-designed prospective studies/series reporting on adult humans, untreated, with cutaneous and/or musculoskeletal features of PsD. RESULTS: Nine references (out of 160 319, publication range 1946-2019) fulfilled the eligibility criteria. No study adopted comprehensive (that is, simultaneous assessment of different PsD manifestations) composite indices as primary outcome measures. Individual studies reported that apremilast and biologics successfully improved outcomes (disease activity index for PsA, minimal disease activity, PsA DAS, psoriasis area and severity index, PsA response criteria) when efficacy analyses were restricted to single manifestations of untreated PsD. Only qualitative synthesis of evidence was possible, owing to the following factors: data heterogeneity (disease classification criteria, outcome measures); unavailable data subsets (focused on early, untreated PsD) at the single study level; and insufficient data on the exposure of participants to previous treatment. CONCLUSION: Effective interventions, albeit limited in scope, were found for early, treatment-naïve PsD. No study provided evidence about the management of co-occurring cutaneous and musculoskeletal manifestations in early, treatment-naïve PsD. This review highlights an unmet need in research on early PsD.

Long-term follow-up of patients in the TIght COntrol of inflammation in early Psoriatic Arthritis (TICOPA) trial.

OBJECTIVES: The TIght COntrol of inflammation in early Psoriatic Arthritis (TICOPA) study was the first strategy trial in psoriatic arthritis using an early treat-to-target strategy to improve clinical outcomes. The current study aimed to review a cohort of patients who had completed TICOPA to judge if the clinical advantage gained by participants in the tight control (TC) arm was sustained, and to explore subsequent therapy. METHODS: A case note review was conducted for a cohort of patients who had participated in TICOPA. Current drug use and clinical status were obtained, with low disease activity judged as no tender or swollen joints, no dactylitis and enthesitis, and no change in treatment required. RESULTS: Approximately five years after completion of the TICOPA study, notes were reviewed for 110 patients [TC, n = 54; standard care (StdC), n = 56]. Disease activity was found to be similar in both groups (current low disease activity: TC 69%, StdC 76%). Biologic use at the end of the study was higher in the TC arm (TC 33%, StdC 9%), but at review a similar percentage in both groups were taking biologic drugs (TC 54%, StdC 52%), whereas MTX use diminished. CONCLUSION: After several years, clinical outcomes and therapeutic drug use were similarly good for patients in both arms of the TICOPA study, with no obvious clinical advantage after TC ended. Notably, TC did not result in greater biological use long term, and MTX use decreased in both arms of the study.

Tofacitinib for the treatment of psoriasis and psoriatic arthritis.

INTRODUCTION: Psoriasis and psoriatic arthritis (PsA) are inflammatory immune-mediated conditions which can cause considerable disability and reduced quality of life. Management can be complex as clinical heterogeneity may lead to different treatment pathways. Tofacitinib is a novel, oral Janus Kinase (JAK) inhibitor with proven efficacy in rheumatoid arthritis. Areas covered: This review analyzes recent studies of tofacitinib in psoriatic disease treatment. The relevant literature was identified using clinicaltrials.gov, PubMed, and Google Scholar. Tofacitinib efficacy was demonstrated in PsA by the OPAL Broaden and OPAL Beyond phase-III studies, and received FDA and EMA approval. Tofacitinib was superior to placebo for the treatment of moderate-to-severe plaque psoriasis in the OPT Pivotal 1 and 2, OPT Retreatment studies, but FDA approval was declined for this indication based on issues of clinical efficacy and long-term safety. Expert commentary: Tofacitinib is an important oral drug for the treatment of PsA. However, the long-term safety data require further evaluation. Tofacitinib and other JAK inhibitors show potential to broaden the treatment options in PsA and other inflammatory conditions.

Current concepts and unmet needs in psoriatic arthritis.

Psoriatic arthritis is a chronic inflammatory arthritis that is part of the spondyloarthropathy group of rheumatic diseases and has associated co-morbidities. It can present with various clinical manifestations making diagnosis and treatment challenging, resulting in significant disability and reduced quality of life for patients. Whilst there have been advances in understanding the pathogenic mechanisms of the disease which have resulted in targeted therapies, there is still the need for further studies as some patients fail or are intolerant of current therapies. Better identification of early disease and knowledge of prognostic markers would enable clinicians to initiate appropriate therapy with the expectation that early aggressive treatment will minimise joint damage progression. Improved knowledge of the condition would also enable clinicians to better tailor specific treatment strategies for each of the various clinical domains in psoriatic arthritis.

The dynamics of response as measured by multiple composite outcome tools in the TIght COntrol of inflammation in early Psoriatic Arthritis (TICOPA) trial.

BACKGROUND: We aimed to evaluate the dynamics of treatment response with different composite measures in the TIght COntrol of inflammation in early Psoriatic Arthritis (TICOPA) trial. METHODS: Participants with early disease-modifying antirheumatic drug-naïve psoriatic arthritis (PsA) were randomised 1:1 to either tight control (TC; 4 weekly review with therapy escalation if criteria not met) or standard care (SC; 12 weekly review). We calculated modified versions of the Psoriatic ArthritiS Disease Activity Score (PASDAS), Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite scorE (GRACE) and Composite Psoriatic Disease Activity Index (CPDAI) at baseline and 12 weekly to 48 weeks by blinded assessor. For missing data, we used the last observation carried forward. Comparison between groups was made by analysis of covariance and comparison of area under the curve (AUC). RESULTS: 206 people were randomised to TC (n=101) or SC (n=105). Significant differences between treatment groups were seen (p<0.0001 for all composite measures). AUC analysis demonstrated a significant difference between groups for the PASDAS but not GRACE and CPDAI. For participants with oligoarthritis, a significant difference between groups was seen for each measure, although the significance levels were greatly diminished (PASDAS, p=0.04; GRACE p=0.01; CPDAI p=0.04). For oligoarthritis using AUC analysis, none of the measures could distinguish between groups. CONCLUSIONS: Composite measures of disease activity were able to distinguish between TICOPA treatment arms, although differences were diminished for those with oligoarthritis. Further data are needed to inform the preferred composite measure for use as the primary outcome in PsA trials. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT01106079) and ISCRCTN registry (ISCRCTN30147736).

A diagnostic dilemma: differentiating between granulomatosis with polyangiitis and tuberculosis.

Granulomatosis with polyangiitis (GPA, formerly Wegener's granulomatosis) can present diagnostic difficulties for the clinician as there can be considerable overlap in features with tuberculosis (TB). Indeed, there are documented cases both of coexisting TB and GPA, and cases wrongly diagnosed as GPA when in fact TB was the underlying diagnosis. This lesson presents a case of GPA where TB was also considered as a differential and highlights the diagnostic and management difficulties when this is the case.