Month 6 Research Articles

Treatment efficacy and patient satisfaction of ustekinumab compared with tumor necrosis factor-alpha inhibitors in Chinese patients with moderate-to-severe psoriasis: a real-world study

Background Ustekinumab is an interleukin (IL)-12/IL-23 inhibitor for the treatment of moderate-to-severe psoriasis. Objective This real-world study compared ustekinumab and tumor necrosis factor-alpha inhibitors (TNFis) in Chinese moderate-to-severe psoriasis patients. Methods Patient health records of 110 moderate-to-severe psoriasis patients initiating or switching biologics were reviewed, with 31 patients receiving ustekinumab (ustekinumab group) and 79 patients receiving TNFis (TNFi group). Results Compared with TNFi group, psoriasis area and severity index (PASI)-75 response rate at month 6 (M6) were elevated (87.1% versus 65.8%, p = 0.026) in the ustekinumab group, whereas the rates at month 1 (M1) and month 3 (M3) and PASI-90 response rates at M1, M3, and M6 only showed an increasing trend (all p > 0.050) in the ustekinumab group than the TNFi group. By subgroup analyses, ustekinumab (versus TNFi) was more effective in patients with biologics therapy history than those without. Compared with the TNFi group, the ustekinumab group had lower dermatology life quality index scores and higher patient satisfaction scores at M3 and M6 (all p < 0.050). Conclusion Chinese moderate-to-severe psoriasis patients treated with ustekinumab have a better treatment response at 6 months with improved quality of life and patient satisfaction after 3–6 months of treatment when compared to TNFi.

Circulating Vesicular-bound HLA-G as Noninvasive Predictive Biomarker of CLAD After Lung Transplantation.

Circulating extracellular vesicles (EVs) have shown promising results as noninvasive biomarkers for predicting disease outcomes in solid organ transplantation. Because in situ graft cell expression of the tolerogenic molecule HLA-G is associated with acceptance after lung transplantation (LTx), we hypothesized that plasma EV-bound HLA-G (HLA-GEV) levels could predict chronic lung allograft dysfunction (CLAD) development. We analyzed 78 LTx recipients from the Cohort-for-Lung-Transplantation cohort, all in a stable (STA) state within the first year post-LTx. At 3 y, 41 patients remained STA, and 37 had CLAD (bronchiolitis obliterans syndrome, BOS, [n = 32] or restrictive allograft syndrome [n = 5]). HLA-GEV plasma levels were measured at month 6 (M6) and M12 in 78 patients. CLAD occurrence and graft failure at 3 y post-LTx were assessed according to early HLA-GEV plasma levels. In patients with subsequent BOS, (1) HLA-GEV levels at M12 were significantly lower than those in STA patients (P = 0.013) and (2) also significantly lower than their previous levels at M6 (P = 0.04).A lower incidence of CLAD and BOS and higher graft survival at 3 y were observed in patients with high HLA-GEV plasma levels at M12 (high versus low HLA-GEVs patients [cutoff 21.3 ng/mL]: freedom from CLAD, P = 0.002; freedom from BOS, P < 0.001; and graft survival, P = 0.04, [log-rank]). Furthermore, in multivariate analyses, low HLA-GEV levels at M12 were independently associated with a subsequent risk of CLAD, BOS, and graft failure at 3 y (P = 0.015, P = 0.036, and P = 0.026, respectively [Cox models]). This exploratory study suggests the potential of EV-bound HLA-G plasma levels as a liquid biopsy in predicting CLAD/BOS onset and subsequent graft failure.

Peripheral blood mononuclear cell low molecular mass protein 7 in acute ischemic stroke: vertical change from admission to discharge and correlation with disability, stroke recurrence, and death.

Low molecular mass protein 7 (LMP7) aggravates abnormal T cell differentiation and atherosclerosis, but its clinical role in acute ischemic stroke (AIS) is still unclear. This study aimed to investigate the correlation of peripheral blood mononuclear cell (PBMC) LMP7 with T cell subsets, disease severity, and prognosis in AIS patients. A total of 162 AIS patients were enrolled for detecting PBMC LMP7 and T helper (Th) 1, Th2, and Th17 cells via reverse transcriptase-polymerase chain reaction and flow cytometry, respectively. In addition, PBMC LMP7 at discharge was also quantified. Increased LMP7 at admission was associated with decreased Th2 cells (P=0.014), elevated Th17 cells (P<0.001), C-reactive protein (P=0.005), National Institutes of Health Stroke Scale (NIHSS) score (P=0.007), and disease severity (defined by NIHSS score) (P=0.010). LMP7 at admission reflected a high risk of stroke recurrence (area under curve (AUC): 0.748, 95% confidence interval (CI): 0.564-0.932), but not mRS score at month 3 (M3) >2 (AUC: 0.585, 95%CI: 0.479-0.691), or death (AUC: 0.723, 95%CI: 0.338-1.000). LMP7 at discharge was reduced compared to that at admission (P<0.001). LMP7 at discharge was positively correlated with the risk of stroke recurrence (AUC: 0.849, 95%CI: 0.735-0.963) and death (AUC: 0.919, 95%CI: 0.836-1.000), but had a weak capacity to reflect mRS score at M3 >2 (AUC: 0.671, 95%CI: 0.578-0.765). PBMC LMP7 positively correlates with Th17 cells, inflammation, and disease severity in AIS patients, meanwhile, its level at discharge shows a good ability to reflect the risks of stroke recurrence and death.

Older people with mild cognitive impairment exhibit lower semantic noise after six months of frequent social conversations

AbstractBackgroundSemantic noise (SN) is a linguistic measurement that quantifies how well the conversation focuses on topics they are discussing. We hypothesized that by engaging in high frequent conversation which aimed to enhance cognitive reserve, the SN observed in older people’s conversations with mild cognitive impairment (MCI) would resemble those with normal cognition (NC).MethodWe analyzed transcriptions from a behavioral intervention randomized controlled trial, I‐CONECT (NCT02871921), which involved semi‐structured conversations between facilitators and participants. In the project, the experimental group engaged in 30‐minute semi‐structured conversations (four times per week for 6 months) via video‐chats. Every video‐chat is oriented to a predefined topic which was provided in a standardized order (e.g., dancing is the 1st conversation topic in the 2nd week). Out of 186 subjects randomized into the trial, 64 participants were randomized into the experimental group. Among them, 52 participants (26 MCI and 26 normal based on NACC D1) with sufficient recording quality during the 2nd week of the intervention (baseline) and during the last week (i.e., 24th) before the month 6 (M6) post‐intervention assessments (post‐trial assessments at M6) were used in this analysis. We utilized an automatic speech recognition (ASR) system to transcribe these recordings and measured each transcription’s SN. We analyzed the statistical difference of MSN (mean SN) between participants with MCI and those with NC at baseline (2nd week) and M6 (24th week).ResultsUsing two‐tailed t‐test, we found that at the baseline, MSN in MCI group was significantly higher than NC group (MCI: 2.09(0.34), NC: 1.87(0.35), p‐value: 0.024). After six months of social interaction, MCI and NC group were not significantly different (MCI: 1.81(0.47), NC: 1.95(0.47), p‐value: 0.280). Moreover, in MCI group, baseline’s MSN was significantly higher than M6’ (p‐value: 0.017), while, in NC group, there was no significant difference between baseline and M6 (p‐value: 0.465).ConclusionsWe showed that, through six months of social interaction, MCI group’s MSN reduces from significantly higher than NC group at the baseline to not significantly different from NC group at M6. This indicates that the high dosage of interactive conversations reduces MSN in the MCI group.

Real-world effectiveness and persistence of secukinumab in the treatment of patients with psoriatic arthritis.

Psoriatic arthritis (PsA) is a complex and heterogeneous inflammatory disease. Secukinumab, a biologic disease-modifying antirheumatic drug (bDMARD), has extensive clinical evidence of efficacy and safety in the treatment of PsA but data in clinical practice are still limited. This study aims to provide real-world evidence on secukinumab use, effectiveness, and persistence in PsA. A retrospective, multicenter study was conducted on patients diagnosed with PsA and treated with secukinumab up to June 2021 at 12 centers in the Valencian Community (Spain). Data on DAS28-CRP, DAPSA, Tender and Swollen Joint Counts (TJC, SJC), enthesitis, dactylitis, skin and nail involvement, pain, patient and physician global assessment (ptGA, phGA) using 100-mm visual analog scale (VAS), and persistence for up to 24 months were collected. A total of 178 patients were included (49% men; mean [standard deviation, SD] age: 51.4 [10.5] years; 39% obese). Secukinumab was used as a first-, second-, or ≥ third-line bDMARD in 37, 21, and 42% of patients, respectively. The percentage of patients achieving at least low disease activity (DAS28-CRP ≤ 3.2) increased from 25% at baseline to 66% at month 6 (M6) and was maintained (75%) up to M24. Mean (SD) DAS28-CRP baseline values (3.9 [1.2]) decreased to 2.9 (1.1) (p < 0.001) at M6 and remained low through M24 (2.6 [1.1]) (p < 0.001). Secukinumab also improved peripheral arthritis increasing the percentage of patients with TJC = 0 (20% baseline; 57% M24) and SJC = 0 (37% baseline; 80% M24). Treatment reduced the percentage of patients with enthesitis (25% baseline; 6% M24), dactylitis (20% baseline; 4% M24), and skin (70% baseline; 17% M24), and nail (32% baseline; 2% M24) involvement. Additionally, we observed improvements in the mean pain VAS (-26.4 mm M24), ptGA (-26.2 mm M24), and phGA (-24.8 mm M24). Secukinumab showed an overall 24-month persistence rate of 67% (95% confidence interval [CI]: 60-74%). Patients receiving first-line secukinumab showed the highest 24-month persistence rate (83, 95% CI: 73-92; p = 0.024). Secukinumab showed long-term effectiveness across the six key PsA domains thus reducing disease activity and pain, which are major treatment goals. This was accompanied by high persistence rates, especially in bDMARD naive patients.

Community-based treatment of cutaneous leishmaniasis using cryotherapy and miltefosine in Southwest Ethiopia: the way forward?

Cutaneous leishmaniasis (CL) is a common, yet massively underreported skin morbidity in Ethiopia. Most patients never seek treatment, as this is offered only in specialized treatment centers. Early diagnosis and treatment through decentralization is crucial to decrease transmission and to reach the NTD roadmap goals. However, little information is available on outcomes and challenges of community-based treatment initiatives. A community-based prospective cohort study was conducted in Ochollo. Patients with clinically or microscopy confirmed CL were included. Cryotherapy was (to be) given weekly with at least four sessions for uncomplicated lesions, and miltefosine was given for 4 weeks for complicated lesions. Miltefosine adherence was assessed by counting pill strips. Clinical and patient-reported outcomes (dermatological life quality index and patient-global assessment) were assessed at month 6 (M6). A total of 107 patients were included, with a median age of 6 years. Two patients refused, and 15 could not be treated as they were too young (<4 years) for miltefosine. Giving cryotherapy to patients weekly was not feasible due to long wound healing times and required use of topical antibiotics. Only 52.4% of miltefosine patients finished >90% of their tablets by M1. Among 46 patients treated with cryotherapy, 24 (52.2%) were cured at M6, and 9 (19.6%) had substantial improvement. The cure rate was 16/39 (41.0%) for miltefosine with 28.2% (11/39) substantial improvement. Before treatment, more than half (57.8%) of patients reported that CL did not negatively impact their life, which significantly increased to 95.2% at M6. At this time, 61.7% of patients said their lesion was clear, which was 1% before treatment. Our study is the first to identify the challenges and opportunities of miltefosine and cryotherapy for community treatment of CL. Although overall cure rates were lower than expected, patient-reported outcomes were generally positive and quite some patients had good improvement.

Variation of Biological and Biochemical Parameters in Patients Receiving Antiretroviral Treatment at the Maradi Regional Hospital during 2021-2022

Aims: To follow the variation of some biological and biochemical parameters in HIV-infected patients under antiretroviral treatment at the Maradi Regional Hospital.&#x0D; Study Design: Retrospective and prospective study&#x0D; Study Location and Duration: Maradi Regional Hospital; from August 2021 to April 2021, a duration of 9 months.&#x0D; Methodology: We followed the variation of some immunological and biochemical parameters in patients living with HIV, evaluated the CD4+ T cell counts, the viral load, the leukocyte count, and carried out the measurement of haemoglobin, glycaemia, creatinemia, and ALAT levels in the blood at the follow-up visits (month 0 (M0), month 3 (M3), and month 6 (M6)), except for the viral load and CD4+ T-cell counts, which were measured at M0 and M6, and the HBsAg test at M0.&#x0D; Results: 99 patients were included in this study. The sex ratio was 2.6 in favour of females. At enrolment, 63.6% of patients had a CD4+ T-cell count &lt; 200/mm³, 56.6% had anaemia, 40.4% had hypoglycaemia and there was a significant increase in patients with an undetectable viral load from enrolment to the last visit at M6. At the end of the study, we observed an improvement in CD4+ T-cell counts, haemoglobin, glycaemia and viral load at each subsequent visit. We did not observe any significant evolution of creatinemia and alanine aminotransferase rate.&#x0D; Conclusion: At the end of the study, we observed an improvement in CD4+ T-cell count, glycaemia, haemoglobin and viral load. We did not observe any particular change in the biochemical parameters of creatinemia and ALAT levels. This shows the non-toxicity of the antiretroviral treatments. Finally, we observed some difficulties in our study which deserve to be improved.

A pilot study of intraneural facilitation versus standard physical therapy for prevention of chemotherapy-induced peripheral neuropathy.

12068 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a debilitating side effect necessitating chemotherapy (CT) dose adjustments or early termination. Intraneural Facilitation (INF) is a novel form of manual physical therapy (PT) developed to mitigate CIPN-related symptoms and improve patients’ functional outcome. We conducted a randomized pilot study evaluating the efficacy of INF vs. standard PT in the prevention of CIPN (NCT 03272919). Methods: Eligible participants were patients with newly diagnosed breast cancer (stages I-III) and gynecologic cancer without preexisting peripheral neuropathy planning to receive platinum-based and/or taxane-based CT. Participants were randomly assigned to either INF or PT arm and received two 45-minute treatments twice a week for six weeks during their CT course. Outcomes reported here are a) assessment of pain between the 2 arms using the Pain Quality Assessment Scale (PQAS), and b) measurement of vascular patterns using ultrasound (US), evaluating pulsatility index, volume flow and peak systolic velocity between the 2 arms. Participants were evaluated at baseline, week 3 (W3), week 6 (W6), and month 3 (M3). PQAS scores ranged from 0 to 10 with subscale evaluations of paroxysmal, surface, and deep pain. Pain scores on a scale from 0 to 10 were grouped into none (0), mild (1-3), moderate (4-6) and severe (7-10). The use of neuropathy medications, CT dose reductions, premature CT discontinuation and participant satisfaction surveys between the two groups were previously reported at SABCS 2022. Results: Of 104 screened participants, 44 met the eligibility criteria, with 38 eligible for analysis (n=20 INF arm and n=18 PT arm). Participants reporting moderate or severe pain in either arm were combined (Table). Pain symptoms peaked at W6 coinciding with cumulative CT effects. At M3, none in the INF arm reported moderate or severe paroxysmal pain compared to two participants in the PT arm. One participant in each arm reported moderate or severe surface or deep pain at M3. The US results showed physiologic impact in both arms at W3 and W6, suggesting their role in preserving neural tissue blood flow and reducing vascular damage. Conclusions: Our study shows fewer number of participants on both intervention arms reporting pain, with numerically lower scores on PQAS in INF arm compared to PT arm, especially during ongoing CT. The US results suggest that INF has a unique pathophysiological impact on the microvasculature compared to standard PT; further studies are needed to validate these findings and potentially address their clinical significance as a combined modality. Clinical trial information: NCT03272919 . [Table: see text]

PHOTOBIOMODULATION THERAPY FOR LARGE SOFT DRUSEN AND DRUSENOID PIGMENT EPITHELIAL DETACHMENT IN AGE-RELATED MACULAR DEGENERATION: A Single-Center Prospective Pilot Study.

To evaluate visual acuity and morphologic changes after photobiomodulation (PBM) for patients affected with large soft drusen and/or drusenoid pigment epithelial detachment associated with dry age-related macular degeneration. Twenty eyes with large soft drusen and/or drusenoid pigment epithelial detachment age-related macular degeneration were included and treated using the LumiThera Valeda Light Delivery System. All patients underwent two treatments per week for 5 weeks. Outcome measures included best-corrected visual acuity, microperimetry-scotopic testing, drusen volume, central drusen thickness, and quality of life score at baseline and month 6 (M6) follow-up. Data of best-corrected visual acuity, drusen volume, and central drusen thickness were also recorded at week 5 (W5). Best-corrected visual acuity significantly improved at M6 with a mean score gain of 5.5 letters ( P = 0.007). Retinal sensitivity decreased by 0.1 dB ( P = 0.17). The mean fixation stability increased by 0.45% ( P = 0.72). Drusen volume decreased by 0.11 mm 3 ( P = 0.03). Central drusen thickness was reduced by a mean of 17.05 µ m ( P = 0.01). Geographic atrophy area increased by 0.06 mm 2 ( P = 0.01) over a 6-month follow-up, and quality of life score increased by 3,07 points on average ( P = 0.05). One patient presented a drusenoid pigment epithelial detachment rupture at M6 after PBM treatment. The visual and anatomical improvements in our patients support previous reports on PBM. PBM may provide a valid therapeutic option for large soft drusen and drusenoid pigment epithelial detachment age-related macular degeneration and may potentially slow the natural course of the disease.

Characterisation of gut microbiota composition in patients with axial spondyloarthritis and its modulation by TNF inhibitor treatment

ObjectiveTo assess whether gut microbiota composition is associated with patient characteristics and may have predictive value on the response to TNF inhibitor (TNFi) treatment in axial spondyloarthritis (AxSpA).MethodsThe study involved...

Long term positional stability of the Argus II retinal prosthesis epiretinal implant

BackgroundThe Argus II Retinal Prosthesis System (Second Sight Medical Products, Sylmar, California) is an epiretinal prosthesis that serves to provide useful vision to people who are affected by retinal degenerative diseases such as retinitis pigmentosa (RP). The purpose of this study was to analyze postoperative movement of the electrode array.MethodsFive patients diagnosed with profound retinal dystrophy who have undergone implantation of retinal prosthesis at Stony Brook University Hospital. Fundoscopy was performed at postoperative month 1 (M1), month 3 (M3), month 6 (M6), month 12 (M12), and month 24 (M24) visits. Fundoscopy was extracted and analyzed via NIH ImageJ. Data analysis was completed using IBM SPSS. Various lengths and angles were measured each postoperative month using ImageJ.ResultsThere was no significant change in distance between the optic disc and the surgical handle (length AB) over the two-year span (F = 0.196, p = 0.705). There was a significant change in distance of length AB over time between patients between M3 and M6 (p = 0.025). A repeated measures ANOVA revealed that there was statistically significant change of the optic disc-tack-surgical handle angle (\U0001d6fe) (M1 to M24) (F = 3.527, p = 0.030). There was no significant change in angle \U0001d71f (the angle to the horizontal of the image), angle \U0001d736 (tack-optic disc-surgical handle), and angle \U0001d737 (optic-disc-surgical handle-tack).ConclusionOur results demonstrate that there may be postoperative movement of the retinal prosthesis over time, as a statistically significant downward rotation is reported over the 2 years span. It is important, moving forward, to further study this movement and to take into consideration such movement when designing retinal implants. It is important to note that this study is limited by the small sample size, and therefore, the conclusions drawn are limited.

Does 18F-FDG PET/CT add value to conventional imaging in clinical assessment of chronic disseminated candidiasis?

Chronic disseminated candidiasis (CDC) classically occurs after profound and prolonged neutropenia. The aim of the CANHPARI study was to assess the clinical value of adding 18F-fluorodeoxyglucose PET/CT to conventional radiology for initial and subsequent evaluations of CDC. A pilot prospective study was conducted in 23 French onco-hematological centers from 2013 to 2017 (NCT01916057). Patients ≥ 18 y.o. suspected for CDC on abdominal conventional imaging (CT or MRI) were included. PET/CT and conventional imaging were performed at baseline and month 3 (M3). Follow-up was assessed until M12. The primary outcome measure was the global response at M3, i.e., apyrexia and complete response to PET/CT. The secondary outcome measure consists in comparison between responses to PET/CT and conventional imaging at diagnosis and M3. Among 52 included patients, 44 were evaluable (20 probable and 24 possible CDC); 86% had acute leukemia, 55% were male (median age 47 years). At diagnosis, 34% had fever and conventional imaging was always abnormal with microabscesses on liver and spleen in 66%, liver in 25%, spleen in 9%. Baseline PET/CT showed metabolic uptake on liver and/or spleen in 84% but did not match with lesion localizations on conventional imaging in 32%. M3 PET/CT showed no metabolic uptake in 13 (34%) patients, 11 still having pathological conventional imaging. Global response at M3 was observed in eight patients. Baseline PET/CT does not replace conventional imaging for initial staging of CDC lesions but should be performed after 3 months of antifungal therapy. [www.clinicaltrials.gov], identifier [NCT01916057].

Healing features of outer retinal layers on SS OCT in VKH disease

AbstractPurpose: To describe restoration of outer retinal layers on Swept‐Source OCT (SS OCT) in Vogt Koyanagi Harada (VKH) disease over a year after the disease onset.Methods: Prospective longitudinal study carried out at the department of Ophthalmology of Fattouma Bourguiba University Hospital of Monastir. Twenty‐one patients (42 eyes) were followed‐up for 12 months after the disease onset. The patients were included at the acute phase and subsequently treated. Sequential SS OCT changes were assessed.Results: Structural SS OCT changes occurred in 24 eyes (57.1%) on month 3 (M3), in 23 eyes (54.8%) on month 6 (M6), and in 19 eyes (45.2%) on month 12 (M12). They included external nuclear layer atrophy (14.3% on M3; 11.9% on M6; and 9.5% on M12); ellipsoid zone disruption (40.5% on M3; 38.1% on M6; and 33.3% on M12); interdigitation zone disruption (42.9% on M3; 40.5% on M6; and 33.3% on M12); and multifocal retinal pigment epithelium thickening (50% on M3; 45.2% on M6; and 31% on M12). No significant association between final visual acuity and external retinal layers alterations at any stage of the study was found. Stepwise analysis showed that the presence of serous retinal detachment at presentation was an independent factor for structural SS OCT changes on M3.Conclusions: After initial onset, SS OCT shows thinning of the outer nuclear layer, disruption of the ellipsoid and interdigitation zones, and multifocal retinal pigment epithelium thickening. Serous retinal detachment at presentation is an independent factor for structural SS OCT changes during the first year of the disease.

Efficacy in linguistic characteristics: I‐CONECT project

AbstractBackgroundResearchers have documented ample evidence suggesting progressive decline in linguistic and syntactic abilities due to cognitive decline. Among measures of syntactic complexity derived from natural language processing (NLP) approaches, we hypothesized that the number of coordinated phrases (CPs, an indicator of sentence complexity) would improve from an intervention which intended to enhance cognitive function by providing social interactions through frequent video‐chats.MethodIn the I‐CONECT project, the experimental group engaged in a high dose of semi‐structured conversations (four times per week) via video‐chats, with additional weekly 10 minutes telephone check‐ins. The control group received only the weekly telephone check‐ins. We analyzed language samples derived from the weekly phone check‐ins (WPCs) in this study. WPCs mainly ask about social activities engaged by the participant during the previous week with some semi‐structured open‐ended questions. Out of 186 subjects who were randomized to the trial, 113 subjects had at least one recording of WPCs with sufficient recording quality during the 2nd, 3rd and 4th weeks of the intervention (baseline) and during the 3 weeks (i.e., 22, 23, 24th) before the month 6 (M6) assessments. We extracted the number of CPs from WPCs of 52 experimental (25 MCI, 27 normal) and 61 control (34 MCI, 27 normal) participants. We regressed CP scores at M6 on age, gender, years of education, the experimental (vs. control) group, controlling for baseline CP scores using a linear regression model.ResultAmong the MCI group, the experimental group’s CP scores were 0.60 points higher than the control group (p = 0.046) at M6, which is equivalent to over 10 years of age difference in CP scores (i.e., ‐0.055×10 = ‐0.55), controlling for covariates listed above (see Figure 1). Among those with normal cognition, we did not find any significant differences between the two groups at M6 (p = 0.414).ConclusionWe found that an indicator of sentence complexity improved among the experimental group compared with the control group among the MCI participants. Our results indicated that language measures are capable of tracking clinically meaningful changes in language samples capitalizing their potential use in clinical trials as automated outcome measures.

Simple Application and Adherence to Gout Guidelines Enables Disease Control: An Observational Study in French Referral Centres.

Background: In a context of therapeutic inertia, the French Society of Rheumatology (SFR) published its first recommendations on gout in 2020, which were deliberately simple and concise. The objectives of the study were to determine the profile of patients referred to French gout-expert centres, and to examine the results of their management and the factors leading to those results. Methods: Three hundred patients attending a first visit for gout management in three French referral centres were retrospectively and randomly included in this multicentre observational study. Visits were performed at baseline (M0) and scheduled for month 6 (M6), month 12 (M12), and month 24 (M24). Results: Patients were 81% male and had a mean age 62.2 ± 15.2 years. Management followed French recommendations after the baseline visit in 94.9% of cases. SU levels were below 6.0 mg/dL in 59.4% of patients at M6, 67.9% at M12, and 78.6% at M24, with increasing clinical improvement (i.e., flare decrease) over 2 years of follow-up. At M24, 50% of patients were treated with allopurinol (313 ± 105 mg/d), which exceeded renal restrictions of doses in 61.5% of them, and 48.2% received febuxostat (84 ± 36 mg/d). The need for a sufficient dosage of ULT was the only predictive factor found for successful achievement of SU levels < 6.0 mg/dL at a given visit. Conclusions: Simple application of gout-management guidelines is feasible in clinical practice and is efficient, with a majority of patients achieving SU targets and clinical improvement.

Influence of CYP2B6 and CYP3A4 polymorphisms on the virologic and immunologic responses of patients treated with efavirenz-containing regimen.

The main objective of this study was to evaluate the effect of CYP2B6 and CYP3A4 polymorphisms on the virological and immunologic responses of HIV patients. A total of 153 HIV-positive patients were enlisted for the study. Viral load and median CD4 T cell counts were evaluated at baseline and month 6 (M6). Samples were identified using TaqMan genotyping assays. The AG in CYP2B6 rs2279343 was associated with VLS compared to homozygous AA. In the dominant model, the AG/GG genotypes were associated with VLS compared to the AA genotype. Moreover, in overdominant model, the AG genotype was associated with VLS compared to AA/GG. Regarding immunological response, only the AG in SNP rs2279343 CYP2B6 was associated with an increase in CD4 cell count between baseline and M6. In CYP2B6 rs3745274, the CD4 cell count at M6 was higher than that of baseline for GG carriers and for GT carriers. In CYP3A4 rs2740574, the TC carriers showed a higher median CD4 count at M6 compared to that of the baseline count, as well as for CC carriers. The best genotypes combination associated with CD4 cell count improvement were AA/AG in SNP rs2279343 and GG/GT in SNP rs3745274. Our findings support the fact that CYP2B6 rs2279343 could help in the prediction of VLS and both SNPs rs3745274 and rs2279343 in CYP2B6 and CYP3A4 rs2740574 were associated with immune recovery in Malian HIV-positive patients.

P-91 Quality of life (QoL)-based end-points for patients with advanced pancreatic ductal adenocarcinoma (aPDAC): Results from the PanDA prospective observational study

Adequate design of clinical trials using QoL-based primary-end points to assess benefit derived from supportive interventions such as exercise, nutrition or complementary therapies is challenging in PDAC due to a lack of available data describing baseline QoL and changes over time for this patient population. PanDA was a prospective observational study of prevalence, assessment and treatment of pancreatic exocrine insufficiency in patients with aPDAC (NCT03616431). QoL data using the EORTC QlQ-C30 and QLQ-PAN26 questionnaires were collected for the follow-up cohort at baseline (BSL), week6 (W6) and month3 (M3). This post-hoc analysis included patients with aPDAC and explored the mean and standard deviation (SD) of the Physical Functioning Scale (PhFS) at BSL, W6, M3) and mean (SD) intra-patient changes over time (W6-BSL and M3-BSL). Subgroup analysis by stage (locally-advanced vs metastatic) was also performed. Percentage of patients evaluable at each time point was reported. Descriptive statistical analysis was performed (Stata v.17). Of 37 patients recruited into the follow-up cohort, 32 met eligibility criteria for this post hoc analysis. Thirty (93.8%), 17 (53.1%; all had paired BSL data) and 13 (40.6%; all had paired BSL data) patients were evaluable with PhFS data available at BSL, W6 and M3, respectively. PhFS (mean (SD); number of observations) did not vary over time when all patients were analysed together (BSL: 76.17(26.46);30) (W6: 79.18(12.74);17) (M3: 74.46(16.76);13). Intra-patient mean changes at W6 (-6.59(15.13);17) or M3 (-5.46(24.82);13). Subgroup analysis identified that changes in W6 were more marked in patients with metastatic disease (-12.14(15.54);7) compared to locally advanced (-2.70(14.32);10). Changes on PhFS over time were likely impacted by selection bias. Intra-patient mean changes at W6 or M3 seemed more reliable to be utilised as primary-end point and sample size calculation in future clinical trials. Subgroup analysis identified that changes in W6 were more marked in patients with metastatic Intra-patient changes rather than pooled results may be more reliable when designing clinical trials with QoL-based primary end-points in aPDAC. W6 assessment may be most informative, as waiting until M3 may compromise the power of the study due to significant drop out.

Utilisation of composite endpoint outcome to assess efficacy of tocilizumab for non-infectious uveitis in the STOP-Uveitis Study

Background/aimsTo use a composite endpoint scoring system in assessing efficacy of two doses of intravenous tocilizumab (TCZ), in eyes with non-infectious uveitis.MethodsData from STOP-Uveitis Study (a phase 2 multicentre, randomised,...

Use of a novel Likert scale instrument to assess patient satisfaction following endovascular and surgical treatment of pelvic venous disorders

Objective The study was aimed at assessing satisfaction with endovascular and surgical treatment, using a novel Likert scale procedure satisfaction instrument, in patients with pelvic venous disorder (PeVD) caused by the gonadal vein reflux. Methods This prospective cohort study included 100 women with PeVD who underwent gonadal veins embolization with coils (GVE group, n = 71) or gonadal veins endoscopic resection (GVR group, n = 29) in 2012–2020. The GVE was performed under local anesthesia and sedation, and was left-sided in 61, right-sided in three, and bilateral in seven patients. The GVR was performed under general anesthesia through transperitoneal ( n = 19) or retroperitoneal ( n = 10) access with three access ports in both cases. The GVR was left-sided in 19, right-sided in one, and bilateral in nine patients. To assess satisfaction with GVE and GVR treatment of PeVD, patients were asked to evaluate statements related to their experience using a new Likert scale instrument. The responses for each item were compared between the groups at Day 7 (D7) and at Month 6 (M6) after the procedure, as was a summary score of all the responses at both time points. The summary score allowed categorization on a spectrum from “completely satisfied” to “completely dissatisfied.” Results The comparison between GVЕ and GVR groups at D7 showed that 80% and 100% of patients, accordingly, reported the overall summary satisfaction, 49% and 79% agreed with a complete pelvic pain relief by D7, 79% and 0% agreed with the absence of a significant discomfort during the first postoperative day, 71% and 100% reported no need for analgesics to relief pain in the assess area, 80% and 100% reported fast return to daily activity, and 19.7% and 100% still experienced pelvic pain at D7 (pain in the GVR group was more severe and required the use of analgesics) (all p &lt; .05). At the same time, 94% and 96% patients were satisfied with the aesthetic result of the procedure at D7 ( p = n.s.). The comparison between GVЕ and GVR groups at M6 showed that 100% of patients in both groups reported overall satisfaction with treatment ( p = n.s.), 96% and 100% confirmed a complete pelvic pain relief by M6, 79% and 65% agreed with the absence of a significant discomfort after the procedure, 79% and 65% reported no need for analgesics, 83% and 100% reported about the return to daily activity (all p &lt; .05), and 100% in both groups were satisfied with the aesthetic result of the procedure ( p = n.s.). Conclusions In patients with PeVD, both GVE and GVR are associated with a high, although not significantly different, overall treatment satisfaction in the long term and have advantages and disadvantages. GVE is associated with less severe post-procedural pain, while GVR provides faster relief of pelvic pain and a return to usual daily activity.

Reminiscence therapy exhibits alleviation of anxiety and improvement of life quality in postoperative gastric cancer patients: A randomized, controlled study.

Although reminiscence therapy alleviates mental illness and improves quality of life in neurocognitive disorders patients, little study reports its clinical application in cancer patients. Thus, this study aimed to explore the effect of reminiscence therapy on anxiety, depression, quality of life, and survival profile in postoperative gastric cancer patients.One hundred sixty surgical gastric cancer patients were enrolled in this randomized, controlled study, then randomly assigned to Reminiscence therapy group (N = 80) and Control group (N = 80) as 1:1 ratio. The evaluation was carried at baseline (M0), month 3 (M3), month 6 (M6), month 9 (M9), and month 12 (M12) after intervention by Hospital Anxiety and Depression Scale and European Organization for Research and Treatment of Cancer quality of life Questionnaire-Core 30 (QLQ-C30). Furthermore, disease-free survival and overall survival were analyzed using follow-up data.Reminiscence therapy decreased HADS for anxiety score at M6, M9, and M12, decreased anxiety rate at M9 and M12 compared to control care; while it did not affect HADS for depression score or depression rate at any time-point. Also, reminiscence therapy raised QLQ-C30 global health status score at M12, reduced QLQ-C30 symptoms score at M6, while did not affect QLQ-C30 function score at any time-point compared to control care. Reminiscence therapy did not affect disease-free survival and overall survival, either. Further subgroup analyses (divided by age and gender) observed that the effect of reminiscence therapy seemed more obvious in patients with age ≤60 years and male patients.Reminiscence therapy exhibits alleviation of anxiety and improvement of quality of life in postoperative gastric cancer patients.