Faculty Bibliography

BACKGROUND:For psoriatic patients who need to receive non-live or live vaccines, evidence-based recommendations are needed regarding whether to pause or continue systemic therapies for psoriasis and/or psoriatic arthritis. OBJECTIVE:To evaluate literature regarding vaccine efficacy and safety and to generate consensus-based recommendations for adults receiving systemic therapies for psoriasis and/or psoriatic arthritis receiving non-live or live vaccines. METHODS:Using a modified Delphi process, 22 consensus statements were developed by the National Psoriasis Foundation Medical Board and COVID-19 Task Force, and infectious disease experts. RESULTS:Key recommendations include continuing most oral and biologic therapies without modification for patients receiving non-live vaccines; consider interruption of methotrexate for non-live vaccines. For patients receiving live vaccines, discontinue most oral and biologic medications before and after administration of live vaccine. Specific recommendations include discontinuing most biologic therapies, except for abatacept, for 2-3 half-lives before live vaccine administration and deferring next dose 2-4 weeks after live vaccination. LIMITATIONS/CONCLUSIONS:Studies regarding infection rates after vaccination are lacking. CONCLUSION/CONCLUSIONS:Interruption of anti-psoriatic oral and biologic therapies is generally not necessary for patients receiving non-live vaccines. Temporary interruption of oral and biologic therapies before and after administration of live vaccines is recommended in most cases.

OBJECTIVE:Individuals of racially and ethnically diverse backgrounds are underrepresented in psoriatic arthritis (PsA) research/clinical trials, despite evidence that their disease presentation, severity and course may be distinct. Here we aim to describe how race, ethnicity and other socioeconomic factors inform disease characteristics in PsA. METHODS:817 consecutive patients with PsA from a large, diverse metropolitan area, were enrolled in an observational, longitudinal registry. Demographics, medical history, medication use, and psoriatic disease phenotype and activity were all recorded and analyzed. RESULTS:The population was 77.4% non-Hispanic White, 2.2% Black, 7.1% Asian, and 9.9% identified as other races or multiracial, and 11.8% identified as Hispanic. Hispanic and non-White individuals had higher tender joint counts (p= 0.033) with similar swollen joint counts (p= 0.308) and medication use (p= 0.171). They also had high rates of radiographic axial disease. Hispanic individuals were significantly more likely to have higher tender joint counts (p= 0.029), higher RAPID3 scores (p= 0.004), and moderate-severe psoriasis (p= 0.010) compared with non-Hispanic White individuals. CONCLUSION/CONCLUSIONS:In this diverse cohort, 22.6% of patients identified as underrepresented racial and/or ethnic groups, mostly Asian or Hispanic. Despite similar swollen joint counts and medication use, non-white individuals have higher tender joint counts compared with white individuals. Phenotypically, they also were more likely to have radiographic axial involvement. These findings may reflect differences in PsA presentation, experience and outcomes in individuals of various racial and ethnic groups, which need to be taken into consideration in clinical care and research design.

INTRODUCTION/BACKGROUND:An important consideration in the treatment of patients with psoriatic arthritis (PsA) is whether the addition of methotrexate (MTX) to biologics has greater efficacy than biologic monotherapy with respect to efficacy outcomes in these patients. OBJECTIVES/OBJECTIVE:To conduct a network meta-analysis (NMA) comparing biologics by treatment class with and without MTX for treatment of adults with active PsA. METHODS:A systematic literature review (SLR) identified randomised, double-blinded, controlled trials, and a Bayesian NMA compared biologics with and without MTX by treatment class (tumour necrosis factor inhibitors (TNFi), interleukin-23 inhibitors (IL-23i) and IL-17i). Efficacy outcomes included American College of Rheumatology 20%, 50% and 70% (ACR20, ACR50 and ACR70) improvement response. RESULTS:The SLR initially identified 31 studies, of which 17 met feasibility criteria for the NMA by containing the 'without MTX' subgroup. For ACR20 efficacy (the most robust assessment examined), all active treatments were significantly better than placebo. No statistically significant differences were demonstrated between biologic monotherapy (for all classes examined) and biologics in combination with MTX for ACR20/50. IL-17i were comparable to IL-23i, and IL-17i were significantly better than TNFi for ACR20. Although limited by fewer trials, TNFi, IL-23i and IL-17i were not statistically different for ACR50/70. CONCLUSIONS:Concomitant use of MTX and biologics did not improve ACR efficacy outcomes versus biologic monotherapy. MTX does not appear to be necessary as a background therapy when biologics are used for the achievement of ACR20/50 responses in patients with PsA.

BACKGROUND:Psoriasis patients with poor therapeutic response to multiple biologic agents are not well-characterized. OBJECTIVE:To describe the characteristics associated with development of multiple biologic failure (MBF) versus good clinical response (GR) to the first biologic. METHODS:This prospective cohort analysis evaluated patients in the multicenter CorEvitas Psoriasis Registry who initiated their first biologic between 2015 and 2020 and were followed for ≥24 months. Multivariable logistic regression identified sociodemographic, clinical, and patient-reported outcomes that differed between MBF (discontinued ≥2 biologics of different classes, each used for ≥90 days, due to inadequate efficacy) and GR (continued use of first biologic for ≥2 years) patients. RESULTS:One thousand thirty-nine patients were analyzed (490 GR [47.2%], 65 MBF [6.3%]). Female sex, shorter psoriasis duration, earlier year of biologic initiation, prior nonbiologic systemic therapy use, history of hyperlipidemia, and Medicaid insurance were significantly associated with MBF, though the latter 2 variables exhibited wider confidence intervals, indicating a lower level of support. The first-to-second biologic sequence most observed with MBF was Tumor necrosis factor-α inhibitor to IL-17 inhibitor use. LIMITATIONS/CONCLUSIONS:Biologic adherence between visits was not evaluated. CONCLUSION/CONCLUSIONS:Approximately 6% of psoriasis patients met MBF criteria. The results identify characteristics associated with MBF that may distinguish patients warranting more frequent follow-up.

The Psoriasis and Psoriatic Arthritis Clinics Multicenter Advancement Network (PPACMAN) is a nonprofit organization whose mission is to optimize the clinical care of patients with psoriatic disease through multidisciplinary collaboration models. The PPACMAN 2021 Annual Meeting was held virtually on December 11, 2021. In all, 50 stakeholders participated in the meeting including dermatologists, rheumatologists, cardiologists, clinical researchers, patient advocacy representatives, and industry representatives. During the opening session of the meeting, presenters provided an update of several research projects dedicated to predicting and preventing psoriatic arthritis (PsA) such as the Psorcast, PAMPA, HIPPOCRATES, and the ELLIPSS studies. The second session centered around novel approaches to deliver multidisciplinary care in psoriatic disease. PPACMAN leadership introduced its wellness program and invited speakers to discuss new advances in cardiovascular disease, sleep disturbance, mental health problems, and dietary interventions in psoriatic disease. The final session of the meeting focused on how to improve patient engagement in their disease and care.

OBJECTIVE:The 2021 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) treatment recommendations provide an evidence-based guide for selecting therapy based on the individual's disease features. Beyond the disease features and associated conditions (eg, uveitis and inflammatory bowel disease), comorbidities play an important role in selecting therapy for an individual patient. METHODS:We performed a systematic literature review. We examined the available evidence to inform treatment selection based on the presence or absence of comorbidities in psoriatic arthritis (PsA). RESULTS:Common comorbidities in PsA that may affect treatment selection include presence of baseline cardiovascular disease (CVD) or high risk for CVD, obesity and metabolic syndrome, liver disease, mood disorders, including depression in particular, chronic infections, malignancies, osteoporosis, and fibromyalgia and/or central sensitization. CONCLUSION/CONCLUSIONS:Comorbidities may influence both the effectiveness of a given therapy but also the potential for adverse events. It is important to assess for the presence of comorbidities prior to therapy selection.

Backgroud: Psoriatic arthritis (PsA) is a chronic, inflammatory arthritis that, when left untreated, can lead to erosions, deformities and decrease in quality of life. PsA is known to be associated with multiple comorbidities, including cardiovascular, metabolic and mental health syndromes, all of which can increase its overall morbidity and mortality. Objective: To characterize a cohort of patients with PsA and understand the impact of depression on PsA outcome measures. Methods: 527 consecutive patients with PsA were enrolled in an observational, longitudinal registry that followed them prospectively at standard of care visits. Demographics, medical history, medication use, and clinical exam were all recorded. Results: Depression was reported in 22.8% of the population, anxiety in 18%, and attention deficit hyperactivity disorder in 4%. Depression was more common in female participants (P <.001). At baseline, individuals with PsA and concomitant depression had similar tender and swollen joint counts and RAPID3 compared to those without depression, and had lower body surface area affected by psoriasis (P =.04). At year one, all patients had improvement in clinical outcomes. However, patients with depression had a significantly higher tender joint count compared to those without depression (P =.001), despite similar swollen joint count and body surface area. Conclusion: In patients with depression, there is a discrepancy between improvement in physician assessed measures and patient reported outcomes. These observations underscore the importance of addressing depression and psychological distress as part of PsA treatment outcomes and points towards the need to address residual pain through co-adjuvant approaches.

OBJECTIVES/OBJECTIVE:Autoantibody seroconversion has been extensively studied in the context of COVID-19 infection but data regarding post-vaccination autoantibody production is lacking. Here we aimed to determine the incidence of common autoantibody formation following mRNA COVID-19 vaccines in patients with inflammatory arthritis (IA) and in healthy controls. METHODS:Autoantibody seroconversion was measured by serum ELISA in a longitudinal cohort of IA participants and healthy controls before and after COVID-19 mRNA-based immunization. RESULTS:Overall, there was a significantly lower incidence of ANA seroconversion in participants who did not contract COVID-19 prior to vaccination compared with those who been previously infected (7.4% vs 24.1%, p= 0.014). Incidence of de novo anti-cyclic citrullinated protein (CCP) seroconversion in all participants was low at 4.9%. Autoantibody levels were typically of low titer, transient, and not associated with increase in IA flares. CONCLUSIONS:In both health and inflammatory arthritis, the risk of autoantibody seroconversion is lower following mRNA-based immunization than following natural SARS-CoV-2 infection. Importantly, seroconversion does not correlate with self-reported IA disease flare risk, further supporting the encouragement of mRNA-based COVID-19 immunization in the IA population.

Background/Purpose: Despite significant heterogeneity in psoriatic arthritis (PsA), randomized controlled trials (RCTs) generally enroll a homogenous subgroup of PsA patients (polyarticular similar to rheumatoid arthritis). In clinical practice, however, majority of patients have oligoarticular disease, often making it difficult to observe meaningful changes. To improve our understanding of how therapies work in the "real world" and among understudied patient subgroups, trials in real world environments are crucial. Before conducting pragmatic studies in PsA, however, it is necessary to define the appropriate outcome measures including patient-reported outcomes (PROs). The objectives of this study were to determine the responsiveness to therapy and minimally clinically important improvement (MCII) for PROs in PsA and to examine the impact of baseline disease activity on the ability to demonstrate change.
Method(s): A longitudinal cohort study was performed within the PsA Research Consortium (PARC). Patients completed PROs including the Routine Assessment of Patient Index Data, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the PsA Impact of Disease questionnaire, and three PRO Measure Information System (PROMIS) instruments (global 10a, depression 8a, and fatigue 8a). Mean change in the scores between visits and standardized response means (SRMs) were calculated. The MCII was calculated as the mean change in score among patients who reported minimal improvement. SRMs and MCIIs were compared among subgroups with moderate to highly active PsA (>=3 swollen and >=3 tender joint counts based on 66-and 68-joint counts respectively) and those with less active PsA (< 3 swollen and < 3 tender joint counts). This cut-off is used as an inclusion criterion in most PsA RCTs.
Result(s): Among 171 patients, 266 therapy courses were included. Mean age was 51 (SD 13.8), 53% were female, and mean body mass index (BMI) was 29.9 (SD 6.5). At baseline, the mean swollen and tender joint counts were 3 and 6, respectively. Therapies initiated included a tumor necrosis factor inhibitor (N=145), interleukin 17 inhibitor (N=55), other biologic or JAK inhibitor (N=14), or an oral small molecule (N=96). SRMs (Figure 1) and MCII for all measures (Table 1 & 2) were small to moderate though greater among those with higher baseline disease activity. BASDAI had the best SRM overall and for less active PsA. cDAPSA and PsAID performed better and comparable to BASDAI respectively in the moderate to highly active PsA subgroup. SRMs were similar among those initiating a biologic therapy compared to those initiating any therapy.
Conclusion(s): SRMs and MCII were relatively small in this real-world population, particularly among those with lower disease activity at baseline. The PsAID and cDAPSA measures performed better in those with higher disease activity compared to Figure 1. Standard Response Means of different measures tested in PARC. Abbreviations: PARC: Psoriatic Arthritis Research Consortium; TNFi: tumor necrosis factor inhibitor; IL17i: interleukin-17 inhibitor; HAQDI: Health Assessment Questionnaire Disability Index; MD global: physician's global assessment; Pt: patient; SJC: swollen joint count; TJC: tender joint count; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; PSAID: Psoriatic Arthritis Impact of Disease; cDAPSA: clinical Disease Activity of Psoriatic Arthritis; MDHAQ: Multidimensional Health Assessment Questionnaire; PROMIS: Patient-Reported Outcomes Measurement Information System Global Short Form; PROMIS10 MH: Patient-Reported Outcomes Measurement Information System Global Short Form Mental Health; PROMIS10 PH: Patient-Reported Outcomes Measurement Information System Global Short Form Physical Health; RAPID3: Routine Assessment of Patient Index Data. those with lower disease activity. In future pragmatic trials, selection of measures should take into account the projected baseline disease activity of patients enrolled