Mean Physician Global Assessment Research Articles

Anifrolumab for systemic lupus erythematosus with multi-refractory skin disease: A case series of 18 patients.

Skin involvement is common in systemic lupus erythematosus (SLE), but may be resistant to conventional treatment. We sought to evaluate the efficacy of anifrolumab (ANI) in refractory cutaneous manifestations of SLE. Case series of patients with refractory cutaneous SLE from three Rheumatology Departments in Greece. Outcome measures were improvement in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), physician global assessment (PGA) and Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI). Clinically relevant improvement in skin was defined as decrease ≥50% (CLASI50) from baseline values. Eighteen patients received ANI; all had active skin involvement at baseline. Mean (SD) SLEDAI and PGA at ANI initiation were 7.4 (2.7) and 1.4 (0.5), respectively, with a mean prednisone dose 4.9 (4.5) mg/day. Mean CLASI (Activity/Damage) at baseline was 13.9 (9.7)/2.9 (4.6). Patients were refractory to a mean 6.3 (1.5) immunomodulatory agents (including hydroxychloroquine and glucocorticoids) before the initiation of ANI. After a mean 8.5 (4.6) months, 89% (n = 16/18) of patients demonstrated significant improvement in general lupus and cutaneous disease activity, and glucocorticoid tapering. Mean SLEDAI and mean CLASI at last visit were 3.4 (1.9) and 2.1 (2.4)/1.4 (2.2), respectively, and mean daily prednisone dose decreased to 2.4 (2.2). Of note, in this group of highly refractory patients CLASI50 was achieved in 16/18 (89%) patients. One patient discontinued ANI after 4 infusions due to a varicella-zoster virus infection and one patient, who initially responded to treatment with ANI, experienced a skin flare due to temporary discontinuation due to Covid 19 infection. DORIS remission and LLDAS were attained in two (11.1%) and eleven (61.1%) patients, respectively. Anifrolumab is highly effective in various skin manifestations of SLE, even after prior failure to multiple treatments.

Clinical Evaluation of an Ayurvedic Preparation “Sangfer” for the Treatment of Anemia in Pregnant Women: An Open-labeled Clinical Study

Background: Iron deficiency during pregnancy is one of the primary causes of anemia in infants and young children. Ithas a negative impact on maternal and fetal health throughout pregnancy with higher likelihood of adverse maternal andfetal outcomes. Maternal iron supplementation is a critical tool to address the global problem of iron deficiency and preventits negative consequences. Method: An open-label non-comparative prospective clinical trial was carried out to evaluatethe effectiveness of “Sangfer” liquid in 16 pregnant women with anemia. “Sangfer” is a polyherbal Ayurvedic proprietarymedication containing elemental iron and zinc and four medicinal herbs viz. Withania somnifera, Emblica officinalis, Asparagusracemosus and Pueraria tuberosa. The aim of the study was to examine its efficacy and safety in treating anemia in pregnantwomen. The dose administered was 10 mL twice daily after food for 12 weeks (84 days). Patients were evaluated at screening(Visit 1 at Day 0), baseline (Visit 2 at Day 1) and during follow-ups (Visit 3 at Day 28, Visit 4 at Day 56 and Visit 5 atDay 84). Results: There was a significant increase in mean hemoglobin levels from 8.08% at Day 1 to 11.19% at the finalvisit at Day 84. The anemia sign and symptom scores also significantly reduced from Day 1 to different follow-up visits.The mean Physician Global Assessment (PGA) score was found to reduce from 1.0 at Day 1 to 0.0 at the final follow-upvisit. Conclusion: “Sangfer” is highly effective for the treatment of anemia during pregnancy. No adverse effects includingserious adverse effects were observed during the study period.

Six-Month Persistence and Multi-domain Effectiveness of Guselkumab in Adults with Psoriatic Arthritis: Real-World Data from the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry.

The aim of this work is to evaluate treatment persistence and clinical outcomes after 6months of on-label guselkumab use in patients with rheumatologist-diagnosed active psoriatic arthritis (PsA) enrolled in the CorEvitas PsA/Spondyloarthritis Registry. Participants with PsA who initiated and persisted with on-label guselkumab use post-Food and Drug Administration (FDA) approval for active PsA (7/13/2020; subcutaneous 100mg at weeks 0, 4, and every 8weeks) at their 6-month follow-up visit (occurring through 3/31/2023) comprised the primary analysis population (On-Label Persisters). Hierarchical, multiplicity-controlled primary and secondary outcomes were mean (95% confidence interval) changes from baseline at 6months in clinical Disease Activity Index for PsA (cDAPSA; primary), Physician Global Assessment (PGA) of arthritis and psoriasis (visual analog scale [VAS] 0-100), patient-reported pain (VAS 0-100), and percent body surface area with psoriasis (%BSA). Paired ttests determined changes that were statistically significantly different from 0 (α = 0.05). Among 114 patients who initiated on-label guselkumab and had eligible baseline and 6-month visits, 90 (78.9%) had persistent use. Among these On-Label Persisters at baseline, mean duration of PsA symptoms = 13.6years; mean cDAPSA, PGA, and patient-reported pain = 22.0, 42.3, and 57.0, respectively; 94.4% had a history of psoriasis (mean BSA 7.6%); and 18.9% and 73.3%, respectively, previously received 1 or ≥ 2 biologic/targeted synthetic disease-modifying antirheumatic drugs. The mean change (improvement) in cDAPSA was -5.4 (-8.5, -2.3; p < 0.001) at 6months. Significant mean improvements in PGA (-19.0 [-24.2, -13.8]), patient-reported pain (-9.1 [-14.4, -3.8]), and %BSA (-5.1 [-7.6, -2.7]) were also observed (all p < 0.001). In this real-world PsA population, generally characterized by longstanding, treatment-resistant, active disease at baseline, persistent guselkumab use in nearly 80% of patients with on-label use was accompanied by significant improvements in joint and skin symptoms and patient-reported pain at 6months. These registry data support results from randomized clinical trials demonstrating the efficacy of guselkumab in improving PsA signs and symptoms. clinicaltrials.gov: NCT02530268.

Nevus of Ota: Combination Treatment with Q-Switched Neodymium-Doped Yttrium Aluminum Garnet Laser and Fractional CO2 Laser.

Nevus of Ota is a facial dermal melanocytic hamartoma occurring more commonly in Asians. The mainstay of treatment is 1064-nm Q-Switched neodymium-doped yttrium aluminum garnet (Nd:YAG) laser, which has shown variable results in pigmented skin. The aim of this study was to determine whether Q-Switched Nd:YAG laser treatment combined with fractional CO2 laser is more efficacious than Q-Switched Nd:YAG laser alone. This was a prospective study with 81 patients. The patients were randomly divided into two groups. Group 1 received 1064-nm Q-Switched Nd:YAG laser alone and group 2 in addition received a fractional CO2 laser as well. Both groups received six sittings at monthly intervals. The treatment response was documented with physician global assessment (PGA) and patient's treatment satisfaction on Wong-Baker Facial Pain Scale (WBFPS). Dermoscopic evaluation was done to see subsurface pigment clearance. In the combination group, 25% of patients had more than 50% improvement as compared with 5.71% in group 1. To achieve a mean PGA score of 1.4, it took six sessions for group 1 versus only four for group 2. Dermoscopic evaluation showed faster pigment clearance in the combination group. Combining two lasers shows statistically significant faster and greater degree of improvement as compared with Q-Switched Nd:YAG laser monotherapy in nevus of Ota.

Real-Life Effectiveness of Tildrakizumab in Chronic Palmo Plantar Psoriasis: A Case Series of 7 Patients with 28 weeks of Follow Up

Palmo-plantar psoriasis (PPP) is highly debilitating and difficult to treat impairing quality of life of patients. Tildrakizumab is an anti-IL23p19 subunit monoclonal antibody approved for the treatment of moderate-severe chronic plaque psoriasis in adult candidates for systemic therapy. Objective of this study is to investigate the safety and efficacy of tildrakizumab in the management of palmo-plantar psoriasis. A total of 7 adults patients with moderate to severe PPP were retrospective analysed. Tildrakizumab 100 mg was administered at weeks 0, 4 and then every 12 weeks, by subcutaneous injection. Patients were visited at baseline, at week 16 and at week 28. Safety and efficacy were assessed at weeks 0, 16 and 28. Physician's Global Assessment (PGA) and Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) clinical score were used to measure the efficacy. The mean PGA score was reduced from 3.6 at baseline to 1.7 after 16 weeks and 1.3 after 28 weeks. The mean PPPASI score was reduced from 19.2 at baseline to 9.2 after 16 weeks and 5.2 after 28 weeks. In conclusion tildrakizumab represents a safe and effective treatment for psoriasis even in difficult areas such as the palms and soles.

Efficacy and safety of belimumab for the treatment of refractory childhood-onset systemic lupus erythematosus: A single-center, real-world, retrospective study.

This study aimed to investigate the efficacy and safety of belimumab for treating children with refractory childhood-onset systemic lupus erythematosus (cSLE). Twenty-six cSLE patients who received belimumab treatment in our hospital from January 2020 to September 2021 (23 of them for more than 52 weeks) were enrolled in this study. Their clinical and laboratory data, assessment of disease activity, glucocorticoid dosage, and treatment-emergent adverse events (TEAEs) were retrieved for analysis. The paired samples t-test and the nonparametric test were used to compare the baseline and post-treatment data. The mean age of onset was 10.3 ± 2.4 years old; the mean disease duration was 41.6 ± 37.4 months; the median Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score was 10 (P 25, P 75: 3, 17); and the mean Physician's Global Assessment (PGA) score at baseline was 1.9 ± 1.0. Compared with the baseline values, there was a significant decrease in the 24-h urine protein quantifications at 24 and 52 weeks of treatment (P<0.05) as well as an elevated complement (C) 3 and C4 levels at 4, 12, 24, and 52 weeks of treatment. In addition, the SLEDAI-2K and PGA scores as well as the percentage of CD19+ B cells were significantly decreased at 12, 24, and 52 weeks of treatment compared with the baseline values (P<0.05). The dosage of glucocorticoid at 4, 12, 24, and 52 weeks of treatment was significantly less than that at baseline or the previous follow-up (P<0.05). At 52 weeks, 14 subjects (53.8%) achieved Lupus Low Disease Activity State (LLDAS), and 4 subjects (15.4%) reached clinical remission (CR). At the last follow-up, 16 subjects (61.5%) achieved LLDAS, and 10 subjects (38.5%) reached CR. Belimumab treatment can significantly improve laboratory indicators, reduce disease activity, and decrease the dosage of glucocorticoid required in children with cSLE. Moreover, it has a good safety profile.

Certolizumab Pegol Use in the Treatment of Moderate-to-Severe Psoriasis: Real-World Data From Two Canadian Centers.

BackgroundCertolizumab pegol (CZP) is a TNF-ɑ inhibitor used to treat moderate-to-severe plaque psoriasis (PsO) in adult patients, including women of childbearing potential (WOCBP) and patients with psoriatic arthritis (PsA). There are currently limited real-world data on CZP for treatment of PsO.ObjectivesTo examine the use of CZP for treatment of PsO in clinical practice at two dermatology clinics in Canada.MethodsWe conducted a retrospective chart analysis of 59 patients with moderate-to-severe psoriasis receiving CZP. Clinical efficacy was measured using the Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA), and Physician Global Assessment (PGA). Drug survival was analyzed using Kaplan-Meier plots.ResultsOf the 59 patients, 36 (61%) were female, of whom 23 (63.9%) were WOCBP. Twenty-three (39.0%) patients received CZP as their first biologic treatment. The main reasons for choosing CZP were its efficacy in both PsO and PsA, and for WOCBP due to little or no cross-placental transfer. Improvement of symptoms was observed after 3 months of treatment and was maintained for the 12-month analysis period. After 12 months of treatment, the patients’ mean PASI score decreased from 13.0 (±5.8) at baseline to 2.3 (±4.3), mean BSA score from 13.1% (±6.7%) to 1.7% (±2.6%), and mean PGA score from 3.0 (±0.6) to 0.8 (±0.6). Overall CZP drug survival rate was 76.3% at 12 months, with no difference between biologic-naive and biologic-experienced patients.ConclusionsCZP was effective and well tolerated in this cohort of patients with moderate-to-severe PsO in a real-world setting.

Comparison of Actinic Keratosis and Severity Index with Physician Global Assessment and Total Lesion Count and the Ability to Predict Skin Cancer.

IntroductionActinic keratosis (AK) is a known indicator for sun damage, and subsequent squamous cell cancer may develop. The actinic keratosis and severity index (AKASI) is a recently developed tool that can evaluate both field cancerization and AK severity.ObjectivesWe sought to evaluate if AKASI was a good predictor of cancer in AK patients and to compare AKASI with both the Physician Global Assessment (PGA) and total lesion count (TLC).MethodsNinety patients with AK were included in the study. Each patient was examined, and AKs were scored with AKASI, PGA and TLC by 2 dermatologists. The AKASI, PGA and TLC values were compared between patients with skin cancer and patients without skin cancer.ResultsMean AKASI, PGA, and TLC scores were 4.9, 1.7 and 9 respectively. The patients with skin cancer had higher scores of AKASI, PGA and TLC compared to the patients without skin cancer (P = 0.022, P = 0.014, P = 0.005, respectively). AKASI, PGA and TLC were very strongly correlated with each other (P < 0.001). The AKASI threshold value for non-melanoma skin cancer was determined to be 5.1.ConclusionsAKASI, PGA and TLC may be used in the assessment of the severity of AK in daily practice or studies and may be considered as valuable tools in determining high-risk patients and to choose treatment option. AKASI seems to have an advantage to give a numeric threshold value for skin cancer.

Factors Associated With Use of Telemedicine for Follow-Up of SLE in the COVID-19 Outbreak.

Objective: To investigate the factors associated with telemedicine (TM) use for follow-up of Systemic Lupus Erythematous (SLE) patients in the COVID-19 pandemic.Methods: This was a single-centered cross-sectional study conducted in Hong Kong. Consecutive patients followed up at the lupus nephritis clinic were contacted for their preference in changing the coming consultation to TM in the form of videoconferencing. The demographic, socioeconomic, and disease data of the first 140 patients opted for TM and 140 control patients preferred to continue standard in-person follow-up were compared.Results: The mean age of all the participants was 45.6 ± 11.8 years, and the disease duration was 15.0 ± 9.2 years. The majority of them were on prednisolone (90.0%) and immunosuppressants (67.1%). The mean SLEDAI-2k was 3.4 ± 2.4, physician global assessment (PGA) was 0.46 ± 0.62 and Systemic Lupus International Collaborating Clinics (SLICC) damage index was 0.97 ± 1.23. A significant proportion of the patients (72.1%) had 1 or more comorbidities. It was found that patients with higher mean PGA (TM: 0.54 ± 0.63 vs. control: 0.38 ± 0.59, p = 0.025) and family monthly income > USD 3,800 (TM: 36.4% vs. control: 23.6%; p = 0.028) preferred TM, while full-time employees (TM: 40.0% vs. control: 50.7%; p = 0.041) preferred in-person follow-up. These predictors remained significant in the multivariate analysis after adjusting for age and gender. No other clinical factors were found to be associated with the preference of TM follow-up.Conclusion: When choosing the mode of care delivery between TM and physical clinic visit for patients with SLE, the physician-assessed disease activity and patient's socio-economic status appeared to be important.

A comparative study in treatment of childhood vitiligo 0.03% tacrolimus versus 0.03% tacrolimus and topical steroids

Background: Vitiligo is an idiopathic, acquired cutaneous achromia, characterized by circumscribed milky white macules. It develops before the age of 20 years in 50% of the patients and before the age of 10 years in 25% of the patients. Methods: This was a 2-year, prospective, comparative study conducted in vitiligo patients with 1 year of active intervention. Fifty patients in the age group of 2–14 years were enrolled in the study. Randomization was performed according to computer-generated random code. Patients with code A received treatment with 0.03% tacrolimus alone and patients with code B received treatment with 0.03% tacrolimus and topical steroids. The primary efficacy variable was the Vitiligo Area Severity Index (VASI), and the secondary efficacy parameter includes the Physician's Global Improvement Score which was computed at the end of the study. The statistical analysis was carried out using statistical software STATA 6.0. Results: Out of these 50 patients, 47 patients completed the study for a period of 1 year. The area-wise VASI reduction and VASI reduction in vitiligo types were analyzed in patients with code A and code B. The mean Physician's Global Assessment Score was 3.041 in the tacrolimus group, and it was 3.261 in the tacrolimus with steroid group. Conclusion: This shows that 0.03% tacrolimus can be effectively used as topical monotherapy in patients with localized stable vitiligo without the adverse effects of topical steroids.

Real‐world effectiveness and safety of apremilast in psoriasis at 52 weeks: a retrospective, observational, multicentre study by the Spanish Psoriasis Group

Little has been published on the real-world effectiveness and safety of apremilast in psoriasis. To evaluate the effectiveness, safety and drug survival of apremilast at 52weeks in patients with moderate to severe plaque psoriasis or palmoplantar psoriasis in routine clinical practice. Retrospective, multicentre study of adult patients with moderate to severe plaque psoriasis or palmoplantar psoriasis treated with apremilast from March 2016 to March 2018. We studied 292 patients with plaque psoriasis and 85 patients with palmoplantar psoriasis. The mean (SD) Psoriasis Area and Severity Index (PASI) score was 10.7 (7.0) at baseline and 3.0 (4.2) at 52weeks. After 12months of treatment, 73.6% of patients had a PASI score of 3 or less. In terms of relative improvement by week 52, 49.7% of patients achieved PASI-75 (≥75% reduction in PASI score) and 26.5% achieved PASI-90. The mean physician global assessment score for palmoplantar psoriasis fell from 4.2 (5.2) at baseline to 1.3 (1.3) at week 52. Overall drug survival after 1year of treatment with apremilast was 54.9 %. The main reasons for treatment discontinuation were loss of efficacy (23.9%) and adverse events (15.9%). Almost half of the patients in our series (47%) experienced at least one adverse event. The most common events were gastrointestinal problems. Apremilast may be a suitable alternative for the treatment of moderate to severe psoriasis and palmoplantar psoriasis. Although the drug has a good safety profile, adverse gastrointestinal effects are common.

Anticipated and Perceived Stigma Among Patients With Psoriasis.

Perceived stigma among patients with psoriasis (PWP) is associated with poorer quality of life. To determine the prevalence and predictors of stigmatizing attitudes that PWP expect and experience from others. We conducted a survey using validated outcome measures to assess the extent to which PWP anticipate and perceive stigma from others. Demographic and clinical characteristics were obtained from electronic medical records. Patients (n = 106) were 48.11% female, 70.75% white, and had a mean age ± SD of 47.90 ± 16.19 years old. Of all, 25.47% self-reported their psoriasis as severe. Mean physician global assessment score ± SD was 2.98 ± 1.81. Two-thirds (66.98%) of patients reported that, in response to seeing their psoriasis-affected skin, they anticipated others to stereotype them as "contagious." Linear regression analyses demonstrated that patient-reported severe psoriasis, compared to mild psoriasis, was associated with greater anticipation of negative stereotypes, social avoidance, and perceived stigma from others (P values < .05). Physician-measured body surface area and global assessment scores were not significantly associated with any outcome. Prevalence of anticipated and perceived stigma among PWP is high. Our results suggest that objective measures of severity may not identify patients at risk of stigma-related distress. Additional methods, such as directly inquiring about stigmatizing experiences, may be needed.

A Comparison of Psoriasis Severity in Pediatric Patients Treated With Methotrexate vs Biologic Agents

Few studies have compared the use of methotrexate and biologics, the most commonly used systemic medications for treatment of moderate to severe psoriasis in children. To assess the real-world, 6-month reduction in psoriasis severity and long-term drug survival (rate and duration of adherence to a specific drug) of methotrexate vs biologics in plaque psoriasis in children. A retrospective medical records review was conducted at 20 European and North American centers. Treatment response was based on site-reported Psoriasis Area and Severity Index (PASI) and/or Physician Global Assessment (PGA) scores at baseline and within the first 6 months of treatment. Participants included all 234 consecutively seen children with moderate to severe psoriasis who received at least 3 months of methotrexate or biologics from December 1, 1990, to September 16, 2014, with sufficient data for analysis. Data analysis was performed from December 14, 2015, to September 1, 2016. PASI, with a range from 0 to 72 (highest score indicating severe psoriasis), and/or PGA, with a scale of 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), and 5 (very severe). Of 234 pediatric patients (103 boys [44.0%]; 131 girls [56.0%]) treated with methotrexate and/or biologics, 163 patients (69.7%) exclusively received methotrexate, 47 patients (20.1%) exclusively received biologics, and 24 children (10.2%) received methotrexate and biologics sequentially. Of the latter cohort, 23 children were treated initially with methotrexate. Mean (SD) age at initiation was 11.6 (3.7) years for methotrexate and 13.3 (2.9) years for biologics (73.2% for etanercept) (P = .002). Among patients evaluated by a scoring method at 6-month follow-up, 75% or greater improvement in PASI (PASI75) was achieved in 12 of 30 patients (40.0%) receiving methotrexate and 20 of 28 patients (71.4%) receiving biologics, and PGA was clear/almost clear (PGA 0/1) in 41 of 115 patients (35.6%) receiving methotrexate and 18 of 37 patients (48.6%) receiving biologics. Achieving PASI75 and/or PGA 0/1 between baseline and 6 months was more likely with biologics than methotrexate (PASI75: odds ratio [OR], 4.56; 95% CI, 2.02-10.27; P < .001; and PGA 0/1: OR, 2.00; 95% CI, 0.98-4.00; P = .06). Decreased mean PASI and PGA scores were associated with biologics more than with methotrexate (PASI effect, -3.13; 95% CI, -4.33 to -1.94; P < .001; and PGA effect, -0.31; 95% CI, -0.56 to -0.06; P = .02). After 1, 3, and 5 years of use, overall drug survival rates for methotrexate were 77.5%, 50.3%, and 35.9%, and for biologics, the rates were 83.4%, 64.3%, and 57.1%, respectively. Biologics were associated with a better confounder-corrected drug survival than methotrexate (hazard ratio [HR], 2.23; 95% CI, 1.21-4.10; P = .01). Discontinuation owing to lack of response was comparable (HR, 1.64; 95% CI, 0.80-3.36; P = .18). Methotrexate and biologics appear to be associated with improvement in pediatric psoriasis, although biologics seem to be associated with greater reduction in psoriasis severity scores and higher drug survival rates than methotrexate in the real-world setting. Additional studies directly comparing these medications should be performed for confirmation.

Comparative Disease Burden in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Axial Spondyloarthritis: Data from Two Corrona Registries.

IntroductionRheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) are three common inflammatory rheumatic diseases that can lead to deformities and joint destruction. Few studies have compared disease burden across patients with these diseases. The objective of this study was to compare disease burden in patients with RA, PsA, or axSpA in routine US clinical practice.MethodsThis study included adults with RA, PsA, or axSpA enrolled in the Corrona RA and PsA/SpA registries between March 2013 and March 2018. Patient and clinical characteristics at enrollment were compared between patients with RA vs. PsA and RA vs. axSpA using t tests or Wilcoxon rank-sum tests for continuous variables and χ2 or Fisher’s exact tests for categorical variables.ResultsA total of 11,350 patients with RA, 2003 with PsA, and 495 with axSpA were included. Patients with RA had shorter mean symptom and disease duration (9.4 and 7.6 years, respectively) than those with PsA (11.2 and 8.4 years) or axSpA (16.7 and 9.8 years). Patients with PsA had lower mean physician global assessment (18.6 vs. 27.3), higher patient global assessment (43.2 vs. 36.9), comparable pain (38.9 vs. 39.5), and lower fatigue (41.1 vs. 43.4) scores than those with RA. Patients with axSpA had comparable mean physician global assessment (25.5 vs. 27.3) and higher patient global assessment (50.2 vs. 36.9), pain (46.1 vs. 39.5), and fatigue (48.3 vs. 43.4) scores than those with RA.ConclusionsDisease burden in patients with PsA or axSpA was comparable to or greater than that in patients with RA on the basis of common patient-reported outcome measures but appeared lower when assessed using RA disease activity measures, suggesting that disease-specific approaches to care are needed to optimize disease management.FundingThis study was sponsored by Corrona, LLC, and financial support was provided by Novartis. The Rapid Service Fee was funded by Novartis.Plain Language SummaryPlain language summary available for this article.

Oral Vancomycin as an Adjuvant Treatment in IBD

Abstract Objective To study the efficacy of oral vancomycin (POV) treatment in pediatric inflammatory bowel disease (IBD). Methods We conducted retrospective and prospective chart reviews, identifying patients using the Division’s Inflammatory Bowel Disease (IBD) registry, ICD-9 and ICD-10 codes for IBD, and recall of patients receiving POV. Patients aged 2–21 years with active IBD at initiation of POV were included unless they had Clostridium difficile infection or primary sclerosing cholangitis (PSC). Pre- and posttreatment analysis included a Physician Global Assessment (PGA), pediatric ulcerative colitis (UC) activity index (PUCAI), and an abbreviated pediatric Crohn’s disease (CD) activity index (PCDAI). The Wilcoxon Signed Ranks test, determined if pre- and post-POV rankings of symptom severity differed. Mann–Whitney U tests assessed improvement in presenting symptoms. Results Nineteen patients met inclusion criteria (12 CD and 7 UC). POV improved the PGA score in 16 of 19 patients (P &lt; 0.001). Mean PGA score pretreatment was 3 ± 0.471; posttreatment mean of 1.58 ± 0.769. Abdominal pain (P &lt; 0.001), diarrhea (P &lt; 0.002), anemia (P &lt; 0.002), and blood in stool (P &lt; 0.001) showed significant improvement. PUCAI and PCDAI scores, pretreatment means of 50 ± 17 and 33 ± 9, respectively, also improved with mean score reduction of 23 in CD and 38 in UC patients after POV initiation (P-value &lt; 0.0001). This improvement was noted for both IBD subtypes. Conclusions POV may be an effective adjuvant treatment for pediatric IBD. Its effectiveness is likely due to a combination of its anti-tumor necrosis factor alpha-α activity and its influence on the gut microbiome. Further controlled studies of POV in IBD are warranted to determine the most efficacious use of POV in pediatric IBD. Aim This study attempts to expand on the current literature to determine efficacy of POV as an adjuvant therapy in treating active IBD in children.

Performance of SLEDAI-2K to detect a clinically meaningful change in SLE disease activity: a 36-month prospective cohort study of 334 patients.

The objective of this paper is to evaluate the performance of the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) in detecting clinically meaningful changes in SLE disease activity. A longitudinal cohort study was conducted of 334 SLE patients during a 36-month follow-up. At each outpatient visit, disease activity was scored using the Physician Global Assessment (PGA) and SLEDAI-2K. Correlations between PGA and SLEDAI-2K were assessed. A clinically meaningful change in SLE disease activity was defined as a ΔPGA ≥ 0.3 points from baseline. Performance of SLEDAI-2K in detecting a clinically meaningful worsening or improvement was tested using receiver operating characteristic (ROC) analysis. Adjusted mean PGA and SLEDAI-2K scores presented a high correlation (rho = 0.824, p < 0.0005). In ROC analysis, a SLEDAI-2K variation presented an area under the curve (AUC) of 0.697 (95% confidence interval (CI) (0.628-0.766), p < 0.0005) to detect a clinically meaningful improvement, with a sensitivity of 28.8% for a SLEDAI-2K ≥ 4 reduction. The AUC to detect a clinically meaningful worsening was 0.877 (95% CI (0.822-0.932), p < 0.0005), with a sensitivity of 35.3%. SLEDAI-2K has a limited ability to detect clinically meaningful changes in SLE disease activity, failing to identify almost two-thirds of cases judged as having a clinically meaningful improvement or worsening. There is a need for more sensitive SLE disease activity measures in clinical practice and research.

Fractional microneedling radiofrequency and fractional 1927 nm thulium laser treatment offer synergistic skin rejuvenation: A pilot case series.

Facial rejuvenation has become an increasingly patient-driven procedure with speedy but significant results and minimal downtime being the holy grail of both patient and practitioners. Fractional techniques with both laser and radiofrequency sources have attracted attention with some good results, but still with some downtime. Combination therapy could offer the best points of the separate techniques to give synergistic results with minimal downtime. The present pilot mini-study investigated the safety and efficacy of facial rejuvenation with a combination of microneedling fractional radiofrequency (MFR) and fractional minimally-invasive thulium laser (FTL) treatment. Four Korean females, ages from 53-63 yr (mean age 58.25), Fitzpatrick skin type Ⅲ-Ⅳ with mild to moderate photoaging-related sequelae participated in the study. On the first pass an MFR system was used with insulated microneedles to deliver a single pass of RF energy to a depth of 1.5 mm-1 mm in the dermis (7.5 W, 30 ms exposure). This was immediately followed by an FTL (5 W, 10 mJ) with 2-3 passes over the whole face, and a further 4-5 passes over the target wrinkles. This was repeated for 6 treatment sessions with 2-weekly intervals, and with a follow-up of 16 weeks after the final session. An analytical digital clinical imaging system captured gross and analytical images, and an independently-scored Physician Global Assessment (PGA) scale was used to assess efficacy in addition to patient satisfaction. Apparent smoothing of wrinkles and general improvement in skin condition was seen following the 3rd to 4th sessions. At the 16-week assessment very clear improvement was seen both with the naked eye and with specific analytical software from the imaging system. The total mean PGA score was 3.35 (out of 4), and all patients were extremely satisfied with the results. No adverse events were reported and pain was minimal. The combination of MFR and FTL was safe and effective, and produced synergistic results in skin rejuvenation in the Asian skin type which were judged to be better than either system used on its own. Further larger population, split-face and controlled trials are warranted to confirm these optimistic results.

Alitretinoin can be a good treatment option for idiopathic recalcitrant trachyonychia in adults: an open-label study.

Trachyonychia can be refractory to conventional treatments including topical, intralesional or systemic corticosteroids, as well as cyclosporine and retinoids. Therefore, new treatment options are needed for recalcitrant trachyonychia. To evaluate the efficacy and safety of oral alitretinoin for idiopathic recalcitrant trachyonychia. A total of 21 adult patients with 210 nails affected by idiopathic recalcitrant trachyonychia were evaluated in this open-label prospective study. All patients took 30 mg of alitretinoin daily for at least 3 months. Clinical outcomes were assessed using the Physician Global Assessment (PGA) scale proposed by Park et al. (degree of roughness: 0, clear; 1, mild; 2, moderate; 3, marked; 4, severe) at baseline and 1, 3 and 6 months after treatment. After 1, 3 and 6 months of treatment, 74.3% (123/210), 98.1% (206/210) and 99.2% (119/120) of nails showed clinical improvement, respectively; 0% (0/210), 22.9% (48/210) and 69.2% (83/120) were completely free from nail abnormalities. The mean PGA score at baseline was 3.4, decreasing significantly to 2.7, 1.3 and 0.7 at 1, 3 and 6 months following treatment, respectively. A small number of participants and lack of a control group were limitations. For the first time, this study evaluated the efficacy and safety of oral alitretinoin for idiopathic recalcitrant trachyonychia in adults. The results suggest that oral alitretinoin can be a good treatment option for adult patients with recalcitrant trachyonychia.

Efficacy of a bleomycin microneedle patch for the treatment of warts.

Warts are a common skin disease caused by infection of the human papilloma virus. Most treatments involving physical destruction of the infected cells, such as cryotherapy and electrocautery, are limited by intense pain, failure, or recurrences. Our aim was to compare the therapeutic effects of a newly developed bleomycin microneedle patch with cryotherapy in the treatment of warts. Forty-two patients with more than two wart lesions were included in the study. The two treatment modalities were randomly applied to different warts on each patient. Treatment efficacy was assessed using the Physician's Global Assessment (PGA) and the Patient's Global Assessment (PaGA). Mean PGA and PaGA scores were not significantly different between cryotherapy and bleomycin microneedle patch treatment. It was also determined that the mean size of all the warts treated with either modality shrank about equally at weeks 8 and 16 after initial treatment. Thus, treatment efficacy of the bleomycin microneedle patch was comparable to that of conventional cryotherapy. According to a visual analogue scale of pain, bleomycin microneedle patch treatment was significantly less painful than cryotherapy (p < .0001). In addition, use of the bleomycin microneedle patch was more tolerable for patients who were reluctant to receive the painful treatment. Thus, the bleomycin microneedle patch can be an effective, convenient, and innovative treatment modality for warts.

Determinants of Patient-Physician Discordance in Global Assessment in Psoriatic Arthritis: A Multicenter European Study.

Patient-physician discordance in global assessment of disease activity concerns one-third of patients, but what does it reflect? We aimed to assess patient-physician discordance in psoriatic arthritis (PsA) and patient-reported domains of health (physical and psychological) associated with discordance. We analyzed the PsAID (Psoriatic Arthritis Impact of Disease), a cross-sectional, multicenter European study of patients with PsA according to expert opinion. Patient global assessment (PGA) and physician global assessment (PhGA) were rated on a 0-10 numeric rating scale. Discordance was defined as the difference (PGA-PhGA) and as the absolute difference |PGA-PhGA| ≥3 points. Determinants of PGA-PhGA were assessed by a stepwise multivariate linear regression among 12 physical and psychological aspects of impact: pain, skin problems, fatigue, ability to work/leisure, functional incapacity, feeling of discomfort, sleep disturbance, anxiety/fear, coping, embarrassment/shame, social participation, and depressive affects. In 460 patients (mean ± SD age 50.6 ± 12.9 years, 52.2% female, mean ± SD disease duration 9.5 ± 9.5 years, mean ± SD Disease Activity Index for Psoriatic Arthritis score 30.8 ± 32.4, and 40.4% undergoing treatment with biologic agents), the mean ± SD PGA was higher than the mean PhGA, with a mean absolute difference of 1.9 ± 1.8 points. Discordance defined by |PGA-PhGA| ≥3 of 10 concerned 134 patients (29.1%), and 115 patients (85.8% of the patients with discordance) had PGA>PhGA. Higher fatigue (β = 0.14), lower self-perceived coping (β = 0.23), and impaired social participation (β = 0.16) were independently associated with a higher difference (PGA-PhGA). Discordance concerned 29.1% of these patient/physician dyads, mainly by PGA>PhGA. Factors associated with discordance were psychological rather than physical domains of health. Discordance was more frequent in patients in remission, indicating more work is needed on the patient perspective regarding disease activity.