Differences In Disease Activity Research Articles

РОЛЬ ЕНДОТЕЛІАЛЬНОЇ ДИСФУНКЦІЇ В РОЗВИТКУ АРТЕРІАЛЬНОЇ ГІПЕРТЕНЗІЇ У ХВОРИХ НА АНКІЛОЗИВНИЙ СПОНДИЛОАРТРИТ

Мета: встановити роль ендотеліальної дисфункції в розвитку артеріальної гіпертензії у хворих на анкілозивний спондилоартрит.Матеріали і методи. Обстежено 110 пацієнтів з анкілозивним спондилоартритом, яким проводили оцінку стану ендотелію. До моменту включення в дослідження всі пацієнти отримували базисну антигіпертензивну терапію, котра не змінювалась під час обстеження.Результати. Встановлено, що практично кожен третій пацієнт хворів на артеріальну гіпертензію, порушення функції ендотелію виявлено у 71,8 % хворих. Достатньо велика когорта обстежених демонструвала знижений рівень ЛПВЩ і підвищений рівень ЛПНЩ. Поряд із тим, виявлено суттєві відмінності за показниками активності за­хворювання (СРБ, ШОЕ, BASDAI) та функціонального статусу (BASFI) у пацієнтів з артеріальною гіпертензією та без.Висновки. Можна припустити, що саме дисфункція ендотелію, котра виникає на фоні системного запального синдрому, ймовірно, є основною причиною розвитку артеріальної гіпертензії у пацієнтів з анкілозивним спондилоартритом, адже відмінностей за іншими класичними факторами ССР, окрім дисліпідемій, виявлено не було.

Although female patients with ankylosing spondylitis score worse on disease activity than male patients and improvement in disease activity is comparable, male patients show more radiographic progression during treatment with TNF-α inhibitors

BackgroundThe clinical presentation of ankylosing spondylitis (AS) differs between genders. Our aim was to investigate differences in disease activity, disease outcome and treatment response between male and female AS patients before and after starting tumor necrosis factor (TNF)-α inhibitors in daily clinical practice. MethodsPatients from the Groningen Leeuwarden AS (GLAS) cohort who started TNF-α inhibitors and who had visits at baseline and after 3 months and/or 2years of follow-up were included. ResultsOf 254 included AS patients, 69% were male. At baseline, female patients scored significantly higher on BASDAI, ASDAS, and tender entheses than male patients. In contrast, CRP, swollen joints, and history of extra-articular manifestations were comparable between genders. Women experienced significantly worse physical function and QoL, whereas men showed significantly more kyphosis and spinal radiographic damage. After 3 months and 2years of follow-up, all clinical assessments improved significantly, with comparable mean change scores for female and male patients; mean 2-year change in BASDAI -2.7 vs. -2.7, ASDAS -1.50 vs. -1.68, tender entheses -2.4 vs. -1.4, CRP -8 vs. -8, BASFI -2.2 vs. -2.1 and ASQoL -5 vs. -4, respectively. Radiographic progression was significantly higher in male patients. Female patients switched more frequently to another TNF-α inhibitor during 2years of follow-up (32% vs. 14%). ConclusionAlthough female patients experienced higher disease activity, worse physical function and quality of life, and switched TNF-α inhibitors more often, clinical improvement during treatment with TNF-α inhibitors was comparable between genders. However, male patients showed more radiographic spinal damage after 2years.

Widespread pain in axial spondyloarthritis: clinical importance and gender differences

BackgroundThere is a remarkable lack of detailed knowledge on pain areas in axial spondyloarthritis (axSpA), and their clinical relevance is largely unknown. Pain area may reflect local disease processes, but amplification of nervous system signalling may alter this relationship. Also, gender differences in pain area may exist in axSpA, possibly confounding disease activity outcomes. Therefore, we firstly detailed pain locations in axSpA and evaluated gender differences. Secondly, we explored the relationship of regional pain definitions with clinical outcomes. Finally, we explored the role of pain area in the assessment of disease activity.MethodsBody charts informed on the presence of axial, peripheral articular and non-articular pain in 170 patients (108 men, 62 women) with axSpA. Multivariate Odds Ratios (ORs) were used to compare genders. General linear models were used to explore clinical differences in disease activity (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]), activity limitations (Bath Ankylosing Spondylitis Functional Index [BASFI]), fear of movement (Tampa Scale for Kinesiophobia 11-item version [TSK-11]), anxiety (Hospital Anxiety and Depression Scale subscale anxiety [HADS-A]) and depression (HADS subscale depression [HADS-D]) between four subgroups classified by widespread non-articular pain (WNAP+/−) and physician global assessment of disease activity (PGDA+/−) (p < .05). Principal Component Analysis (PCA) was performed to explore gender differences in the structure of disease activity.ResultsAxial thoracic pain was least prevalent (lumbar, 74.4%; cervical, 47.6%; cervicothoracic, 47.6%; thoracic, 32.4%), but it was about three times more likely in women (OR, 2.92; p = .009). Axial cervicothoracic junction pain spread more diffusely in women (OR, 2.48; p = .018). Women exhibited a two- to threefold increased likelihood of widespread axial (OR, 3.33; p = .007) and peripheral articular (OR, 2.34; p = .023) pain. A subgroup of WNAP+/PGDA− combined with low PGDA (27% of all patients) was associated with worse BASFI, BASDAI, HADS-A and HADS-D in men and worse TSK-11 and HADS-A in women (p < .05). Disease activity outcomes showed a two-factor structure in women but not in men.ConclusionsIn patients with axSpA, the location and spread of pain was different between genders and was related to worse clinical status. On the basis of pain area and PGDA, clinical subgroups exhibiting a remarkably distinct health status were identified. Outcome instruments such as BASDAI should acknowledge gender differences to ensure structural validity.

Proposal of Classification Criteria for HTLV-1-Associated Myelopathy/Tropical Spastic Paraparesis Disease Activity.

Human T-lymphotropic virus type 1 (HTLV-1)-associated myelopathy/tropical spastic paraparesis (HAM/TSP) is a rare chronic neuroinflammatory disease. While the disease usually progresses slowly without remission, there is a subgroup of patients with rapid progression and another subgroup with very slow progression. However, there have been no reports to date that have successfully determined the criteria to differentiate these subgroups. Therefore, we initially conducted a statistical modeling analysis to explore representative patterns of disease progression using data from our nationwide HAM/TSP patient registration system (“HAM-net”). The latent class mixed model analysis on the retrospective data (n = 205) of disease progression measured by the change in Osame Motor Disability Score from the onset of the disease to diagnosis demonstrated three representative progression patterns of HAM/TSP. Next, to test the effect of the progression rate at the initial phase of the disease on long-term prognosis, we divided 312 “HAM-net” registered patients into three groups (rapid, slow, and very slow progressors) based on the progression rate, then analyzed long-term functional prognosis of each group using the Kaplan–Meier method. Our data clearly demonstrated that the rapid progression at the early phase of the disease is an important poor prognostic factor. Moreover, to determine the biomarkers capable of discriminating the difference in disease activity, we compared the value of potential biomarkers of HAM/TSP among rapid (n = 15), slow (n = 74), very slow (n = 7), and controls (non-HAM/TSP patients, n = 18). The cerebrospinal fluid (CSF) levels of neopterin and C-X-C motif chemokine 10 (CXCL10) were the most valuable markers to discriminate among rapid, slow, and very slow progressors. To differentiate between rapid and slow progressors, the cut-off values of neopterin and CXCL10 were determined to be 44 pmol/mL and 4400 pg/mL, respectively. Furthermore, to differentiate between slow and very slow progressors, these values were determined to be 5.5 pmol/mL and 320 pg/mL, respectively. Notably, we found that CSF levels of these markers in very slow progressors were within the reference range. Thus, we propose a new classification criteria for disease activity of HAM/TSP that may contribute to improving the treatment algorithm for HAM/TSP.

Short article: Switching to a infliximab biosimilar: short-term results of clinical monitoring in patients with inflammatory bowel disease.

Currently, a biosimilar of Remicade is available (CT-P13). Switching patients from Remicade to a biosimilar is still under debate, especially for patients with inflammatory bowel disease (IBD). In a retrospective study, we investigated the feasibility and safety of switching patients with IBD from Remicade to a biosimilar infliximab. At two large general hospitals in The Netherlands, adult patients with a diagnosis of Crohn's disease or ulcerative colitis being treated with Remicade were asked to switch to the biosimilar infliximab (CT-P13). After switching, patients were closely monitored by assessing disease activity and evaluating disease-specific measures (serum C-reactive protein and fecal calprotectin). Adverse effects were recorded and serum infliximab concentrations measured. All parameters were assessed at baseline (t=0) and after two infusions with biosimilar infliximab (±week 16). Among 197 patients with IBD switched to the biosimilar infliximab (∼77%), and no difference in disease activity was observed. Disease-specific measures did not differ between baseline and after two infusions with the biosimilar. Apart from one infusion-related reaction, no serious or unexpected adverse reactions were reported. Serum trough concentrations did not differ between baseline and after switching [median: 4.1 µg/ml (range: 0.03-22 µg/ml) vs. 4.6 µg/ml (range: 0.03-22 µg/ml); P=0.08, n=98]. These data suggest that switching patients with IBD to the biosimilar infliximab is safe in clinical practice. After the switch, no clinically relevant differences were observed in disease activity, adverse effects, and serum infliximab concentrations.

Smoking, body mass index, disease activity, and the risk of rapid radiographic progression in patients with early rheumatoid arthritis

BackgroundIdentification of risk factors for rapid joint destruction in early rheumatoid arthritis (RA) can be helpful for optimizing treatment, and improving our understanding of destructive arthritis and its mechanisms. The objective of this study was to investigate the relationship between early RA patient characteristics and subsequent rapid radiographic progression (RRP).MethodsAn inception cohort of patients with early RA (symptom duration < 12 months), recruited during 1995–2005 from a defined area (Malmö, Sweden), was investigated. Radiographs of the hands and feet were scored in chronological order according to the modified Sharp–van der Heijde score (SHS), by a trained reader. RRP was defined as an increase of ≥ 5 points in SHS per year.ResultsTwo hundred and thirty-three patients were included. Radiographs were available from 216 patients at baseline, 206 patients at 1 year, and 171 patients at 5 years. Thirty-six patients (22%) had RRP up to 5 years. In logistic regression models, rheumatoid factor (RF) and anti-cyclic citrullinated peptides (anti-CCP), and increased erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) at baseline, predicted RRP over 5 years. Patients identified as overweight or obese had a significantly reduced risk of RRP up to 5 years (odds ratio (OR) 0.26; 95% confidence interval (CI) 0.11–0.63; adjusted for RF, baseline erosions, and ESR). Similar point estimates were obtained when stratifying for antibody status, and in models adjusted for smoking. A history of ever smoking was associated with a significantly increased risk of RRP up to 5 years, independent of body mass index (BMI) (OR 3.17; 95% CI 1.22–8.28; adjusted for BMI). At the 1-year follow-up, erosive changes, Disease Activity Score of 28 joints, Health Assessment Questionnaire, swollen joint count, and patient’s global assessment of disease activity and pain were also significantly associated with RRP up to 5 years.ConclusionsA history of smoking, presence of RF and/or anti-CCP and early erosions, high initial disease activity and active disease at 1 year, all increase the risk of RRP. Patients with a high BMI may have a reduced risk of severe joint damage. This pattern was not explained by differences in disease activity or antibody status. The results of this study suggest independent effects of smoking and BMI on the risk of RRP.

P709 Is there a difference in adalimumab drug levels according to pen vs. syringe use: An international, multi-centre retrospective analysis

In an intensive pharmacokinetic study of adalimumab (ADA) in Crohn’s disease (CD), trough drug levels were significantly higher in syringe compared with pen users.1 Further data addressing the impact of delivery device on ADA drug level are lacking. Retrospective observational study of adult CD patients receiving 40 mg ADA fortnightly (for >14 weeks) across five centres. Therapeutic drug monitoring (TDM) was performed with the following ELISA kits: Shikari (Matriks) at Alfred Health, St Vincent’s Hospital, Monash Health and 54% of samples from Liverpool Hospital, Australia; LISA Tracker (Theradiag) at CHU Saint-Étienne, France; Promonitor (Grifols) for 46% of samples from Liverpool Hospital. The first recorded drug level (independent of indication), markers of disease activity including Harvey Bradshaw Index (HBI), C-reactive protein (CRP) and faecal calprotectin (FCP), and patient/disease demographics were collected. Drug levels >4.9 μg/ml were considered therapeutic, active disease was defined as CRP >5 mg/l or FCP >150 μg/g. A total of 218 patients were included. 52% of patients were male, mean age 39 years, 60% received concomitant immunomodulation. Mean FCP was 283 μg/g and CRP 10.2 mg/l at TDM. Pens were used by 64% of the cohort. Syringe users had a higher albumin, lower HBI and higher rates of concomitant immunomodulation than pen users (40 vs. 38 g/l, p = 0.016; 2.2 vs. 3.4, p = 0.017; 71 vs. 54%, p = 0.014). No significant differences in disease activity (CRP or FCP), duration or patient demographics between delivery device were observed. Considering all patients, there was no difference in drug levels in pen vs. syringe (5.3 vs. 5.2 μg/ml, p = 0.442, Figure 1a). Furthermore, drug levels did not differ between pen vs. syringe when controlling for disease activity (CRP or FCP). On subgroup analyses by centre, syringe users at Alfred Health had significantly higher drug levels than pen users (6.1 vs. 4.5 μg/ml, p = 0.039; Figure 1b) and a greater proportion were therapeutic (75 vs. 44%, p = 0.045). In contrast, a higher proportion of pen users from CHU Saint-Étienne had therapeutic ADA level (79 vs. 42%, p = 0.027), yet no significant difference in absolute drug level (7.9 vs. 4.5 μg/ml, p = 0.119). No differences between delivery device were seen at the remaining sites. Drug level according to pen and syringe use at all participating sites (a) and at Alfred Health (b) Drug delivery device does not appear to significantly affect ADA drug levels. Nevertheless, given site-specific differences between pen and syringe, further prospective controlled studies which include patient administration training are warranted. 1. Ward MG, Thwaites PA, Beswick L, et al. Intra-patient variability in adalimumab drug levels within and between cycles in Crohn’s disease. Aliment Pharmacol Ther, 2017;45:1135–1145.

Obesity is a strong predictor of worse clinical outcomes and treatment responses in early rheumatoid arthritis: results from the SWEFOT trial

ObjectivesThe aim of this paper was to analyse the impact of obesity, in addition to known predictors, on disease outcome in early rheumatoid arthritis (RA).MethodsBody mass index (BMI) was available...

Efficacy of embedded nurse-led versus conventional physician-led follow-up in rheumatoid arthritis: a systematic review and meta-analysis

ObjectiveTo compare the efficacy of embedded nurse-led versus conventional physician-led follow-up on disease activity in patients with rheumatoid arthritis (RA).MethodsIn a systematic literature search, we identified randomised controlled trials (RCTs)...

Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis Frequently Have Subclinical Inflammation in the Proximal Colon

Patients with primary sclerosing cholangitis (PSC) and ulcerative colitis (UC) have a high risk of colonic neoplasia. Neoplasia frequently develops in the proximal colon in patients with PSC. Histologic inflammation is an independent risk factor for the development of neoplasia; we investigated whether patients with UC and PSC have more subclinical disease activity than patients with UC alone. We performed a retrospective analysis of data from 143 patients (205 examinations) with ulcerative pancolitis who were in clinical remission and treated at a tertiary medical center from May 2011 through May 2016. Endoscopic and histologic activity were compared between patients with PSC (from 36 examinations) and without PSC (from 169 examinations). Disease activity was scored per colonic segment using a modified Mayo endoscopic subscore and histologic assessment. In each colonic segment, differences in disease activity and the degree of discordance between endoscopic and histologic inflammation among UC patients with and without PSC were compared. Patients with UC-PSC had significantly more subclinical endoscopic (odds ratio [OR], 4.21; 95% CI, 1.67-10.63) and histologic activity (OR, 5.13; 95% CI, 2.25-11.68) in the right colon, as well as greater degree of histologic than endoscopic inflammation in the proximal colon (OR, 3.14, 95% CI, 1.24-7.97), compared with patients without PSC. Patients with UC-PSC had significantly less histologic activity in the rectum on multivariate analysis (OR, 0.24; 95% CI, 0.08-0.72). Patients with UC and PSC who are in clinical remission are significantly more likely to have endoscopic and histologic inflammation in the right colon than patients with UC without PSC. Our findings provide insight into cause of colorectal cancer in UC patients with PSC.

Assessment of clinical efficacy and safety in a randomized double-blind study of etanercept and sulfasalazine in patients with ankylosing spondylitis from Eastern/Central Europe, Latin America, and Asia.

Despite the demonstrated efficacy of etanercept for the treatment of ankylosing spondylitis (AS), sulfasalazine is often prescribed, especially in countries with limited access to biologic agents. The objective of this subset analysis of the ASCEND trial was to compare the efficacy of etanercept and sulfasalazine in treating patients with AS from Asia, Eastern/Central Europe, and Latin America. A total of 287 patients, 190 receiving etanercept 50 mg once weekly and 97 receiving sulfasalazine 3 g daily, from eight countries were included in this subset analysis. Differences in disease activity and patient-reported outcomes assessing health-related quality-of-life (HRQoL) parameters in response to treatment were analyzed using the Cochran-Mantel-Haenszel test for categorical efficacy endpoints and analysis of covariance model for continuous variables. At week 16, a significantly greater proportion of patients receiving etanercept achieved ASAS20 (79.0 %) compared with patients receiving sulfasalazine (61.9 %; p = 0.002). At week 16, treatment with etanercept also resulted in significantly better responses than sulfasalazine for ASAS40 (64.7 vs. 35.1 %; p < 0.001), ASAS5/6 (48.1 vs. 26.3 %; p < 0.001), proportion of patients achieving 50 % response in Bath AS Disease Activity Index (65.8 vs. 42.3 %; p < 0.001), partial remission (35.3 vs. 17.5 %; p = 0.002), and all HRQoL parameters. Both treatments were well tolerated. Etanercept was significantly more effective than sulfasalazine in the treatment of patients with AS from Asia, Central/Eastern Europe, and Latin America.

P-207 Racial Differences in Initial Presentation, Early Treatment, and 1-Year Outcomes of Pediatric Crohnʼs Disease

Racially disparate care has been shown to contribute to suboptimal healthcare outcomes for minorities in some settings. Using data from the ImproveCareNow (ICN) network, we sought to investigate differences in the medical management and outcomes of pediatric patients with Crohn's disease (CD) at time of diagnosis and 1-year post-diagnosis. ICN is a learning health network for children with inflammatory bowel disease. It contains data collected prospectively and longitudinally during outpatient encounters. Inclusion criteria: all CD patients ≤21 years of age with a visit between September 2006 and October 2014, with the first recorded encounter ≤90 days from the date of CD diagnosis and an encounter 1-year post diagnosis (within 60 days). Analyses were conducted at 2 time periods: baseline (diagnosis) and the 1-year encounter. Analyses included summary statistics, nonparametric Kruskal-Wallis test, Χ2, and Fisher's exact tests as appropriate. Baseline: 976 patients (Black = 118 [12%], White = 858 [88%], mean age = 13 years, 63% male) from 39 sites were included. Black children had a higher percentage of Medicaid insurance (44% versus 11%, P < 0.001). There were no race differences in gender, age at diagnosis, BMI, disease behavior or disease location. Black children had more active disease according to Physician Global Assessment (PGA) at diagnosis (remission 29% versus 35%, mild 37% versus43%, moderate/severe 34% versus 22%; P = 0.027), though there was no difference according to the short Pediatric Crohn's Disease Activity Index (sPCDAI) (P = 0.67). Black children had a lower hematocrit (34.8 versus 36.7, P < 0.001) and albumin level (3.6 versus 3.9, P = 0.001). There were no differences in initial treatment (Black versus White: anti-TNFα 12% versus 11%, P = 0.94; thiopurines 32% versus 34%, P = 0.75); corticosteroids 58% versus 61%, P = 0.71). Black children had more psychosocial concerns noted at diagnosis (30% versus 12%, P = 0.021). At 1 year following diagnosis, Black children had more active disease according to PGA (remission 63% versus 75%, mild 26% versus 29%, moderate/severe 11% versus 6%; P = 0.016); however, there was no difference in disease activity based on the sPCDAI (P = 0.060). Black children had a lower hematocrit (36.6 versus 37.9, P = 0.004), lower albumin level (3.9 versus 4.2, P <0.001), and higher erythrocyte sedimentation rate (20.0 versus 15.2, P = 0.03). There were no differences in treatment (Black versus White: anti-TNFα 35% versus 33%, P = 0.69; thiopurines 47% versus 44%, P = 0.52); corticosteroids 7% versus 10%, P = 0.32). In this cohort, minor differences were identified between Black and White children at baseline and 1-year, with Black children having slightly worse disease activity by some measures. Specifically, statistical differences were identified with respect to hematocrit, albumin, and erythrocyte sedimentation rate (at 1-year), although these differences may not have been clinically meaningful. Remission rates were lower in Black children according to PGA, although not according to C-reactive protein and sPCDAI, suggesting that either Black children were perceived to be more ill despite similar disease activity, or that Black children actually were more ill, but this was not adequately reflected by the sPCDAI. Racial differences in treatment were not identified.

So You Think You Can Dance: Dance as Therapy for Adult Patients With IBD: A Pilot Study

Introduction: Patients with Inflammatory Bowel Disease (IBD) often struggle with psychosocial issues of depression and anxiety with poor quality of life. Dance therapy may be a beneficial untapped resource to address these concerns. Dance therapists believe that mental and emotional problems are held in the body in the form of muscle tension and constrained movement patterns. They believe the body can affect attitude and feelings, both positively and negatively Aim: This study is a pilot study to determine the effectiveness of dance as therapy in adult IBD patients Methods: Patients with IBD were recruited from a single university IBD practice to partake in a 6 week dance class. Each class was 1.5 hours and occurred once a week. Before, during, and after each class, participants were asked to complete questionnaires that explore their emotional and psychological status, their opinions about the experience, disease activity, and quality of life using previously validated scales. Results: Nine patients with IBD,7 female, all non-smokers, 4 with UC and 5 with Crohn's disease, aged 25 to 55 years participated. Seven patients were in clinical remission. 22% reported depression and 33% had generalized anxiety disorder. The mental health component of SF 36 showed a statistically significant improvement in the vitality sub-score (p0.06), Work productivity (p>0.1), Brief COPE (p>0.6), and Pittsburgh Sleep Quality Index (p>0.23 between Week 6 and Week 0. The subjective comments showed all 9 patients enjoyed the group activity, felt a strong sense of community, felt dance gave a positive outlook on life, and can turn to dance as a tool. Conclusion: Conclusion: Though there was no significant difference in disease activity, SIBDQ, work productivity, or sleep quality, there was a trend in improvement in the mental health component of the SF-36, specifically in the vitality score. The subjective opinions about the experience were positive. Dance may improve self-esteem, reduce stress, decrease isolation, and increase feelings of well-being. The negative results of this study may owe to the small sample size. Further research is warranted to look at dance as a component of a multidisciplinary management for IBD.

Differences in disease activity in cryopyrin-associated periodic syndrome in mutation-positive and mutation-negative patients

Cryopyrin-associated periodic syndrome (CAPS) is an inherited disease which is caused by gain-of function mutations in CIAS1 gene function resulting in increased secretion of active IL-1β. As known more than 40% of patients with CAPS are genetic negative in CIAS1 gene. One of theories explains this is a fact is a somatic mozaicism.

Gender-attributable differences in outcome of ankylosing spondylitis: long-term results from the Outcome in Ankylosing Spondylitis International Study.

To investigate gender-attributable differences regarding clinical outcome [disease activity, physical function and quality of life (QoL)] and radiographic damage in patients with AS over time. Data from the Outcome in AS International Study were used. Disease activity was assessed by the BASDAI, ASDAS and CRP; physical function by BASFI; QoL by the Short Form-36, Ankylosing Spondylitis Quality of Life (ASQoL) score and European Quality Of Life scale; and radiographic damage by the modified Stoke AS Spine Score (mSASSS). Cross-sectional comparative analyses were done at baseline. Next, separate models were created to assess gender-attributable differences on each outcome measure over time using time-adjusted generalized estimating equations. A total of 216 patients [154 (72.3%) males, mean age 43.6 years (s.d. 12.7), symptom duration 20.5 years (s.d. 11.8), mean follow-up duration 8.3 years (s.d. 4.1)] were included. At baseline, male compared with female patients had lower self-reported disease activity (BASDAI 3.2 vs 3.9, P = 0.03) but more radiographic damage (mSASSS 13.8 vs 6.5, P = 0.02). No significant gender-attributable differences in other clinical parameters were found. In multivariable analysis, male gender was significantly associated with a better ASQoL (B = -1.18, 95% CI: -2.17, -0.20, P = 0.02), and in a separate model with a higher mSASSS over time (B = 8.24, 95% CI: 4.38, 12.09, P < 0.01). In this prospective cohort study, no gender-attributable differences in disease activity or physical function over time were found. However, radiographic damage was more severe in males. Furthermore, males had a better QoL over time.

Comparison of golimumab 100-mg monotherapy to golimumab 50 mg plus methotrexate in patients with rheumatoid arthritis: Results from a multicenter, cohort study

Objective. The aim of this study was to compare the efficacy and safety of golimumab (GLM) 50 mg + methotrexate (MTX) combination therapy and GLM 100 mg monotherapy in patients with rheumatoid arthritis (RA).Methods. The subjects were 115 RA patients (92 females and 23 males; median (range) age, 64 (17–87) years; median (range) disease duration, 8 (0.6–48) years) started on GLM. Eighty-three patients received GLM 50 mg/4 weeks + MTX (C group; median (range) MTX dosage 8 (2–16) mg/week), and 32 patients received GLM 100 mg/4 weeks (M group).Serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), matrix metalloproteinase-3, disease activity score (DAS) 28-ESR, DAS28-CRP, simplified disease activity index, and clinical disease activity index were evaluated 4, 12, and 24 weeks after starting GLM.Results. There were no significant differences in disease activity, adverse events, and drug continuation rates at 24 weeks between the groups. The DAS28-ESR remission rate was 34% in the C group and 26% in the M group.Conclusions. GLM 100 mg monotherapy improved disease activity as well as GLM 50 mg + MTX combination therapy. GLM 100 mg monotherapy appears to have a sufficient therapeutic effect in RA patients who cannot take MTX.

Anti-TNFα agents and methotrexate in spondyloarthritis related uveitis in a Chinese population.

This study seeks to evaluate the clinical characteristics of spondyloarthritis (SpA)-related uveitis in a cohort from South China and to assess the efficacy and safety of therapies based on TNF blockers. SpA patients with uveitis admitted to a south China hospital were enrolled. Demographic information, clinical characteristics, laboratory findings, intraocular inflammation, visual acuity, macular thickness, and treatments were documented. Of the 1,036 SpA patients reviewed, 182 had uveitis. Ankylosing spondylitis (AS) was the most common subtype. Unilateral uveitis was found in 51 cases (51/182, 28.0%), and unilateral alternating uveitis was found in 75 cases (75/182, 41.2%). Half of the cases were recurrent uveitis (52.2%), and acute onset was common (76.4%). The most serious complication was vision loss (0.5%). No significant difference in disease activity was found between the SpA patients with or without uveitis. Predominant improvements were found in cases treated with all three anti-TNFs (infliximab, adalimumab, and etanercept) and anti-TNFs plus methotrexate (MTX). Monotherapy of methotrexate was not adequate for inducing remission. Monotherapy of etanercept was not as effective as adalimumab and infliximab, mainly in the prevention of recurrence. No significant difference in effectiveness was found among the three anti-TNFs if MTX was added. Etanercept plus MTX were well tolerated. Infliximab and adalimumab were associated with more tuberculosis and/or hepatitis flares. Uveitis is common in SpA patients. Severe complications may develop in prolonged and intractable cases. Treatments based on anti-TNFs had good clinical response, and better safety documentation were observed in etanercept plus MTX compared to the other two anti-TNF monoclonal antibodies plus MTX.

Clinical Presentation and Five-Year Therapeutic Management of Very Early-Onset Inflammatory Bowel Disease in a Large North American Cohort

To evaluate the presentation, therapeutic management, and long-term outcome of children with very early-onset (VEO) (≤ 5 years of age) inflammatory bowel disease (IBD). Data were obtained from an inception cohort of 1928 children with IBD enrolled in a prospective observational registry at multiple centers in North America. One hundred twelve children were ≤ 5 years of age with no child enrolled at <1 year of age. Of those, 42.9% had Crohn's disease (CD), 46.4% ulcerative colitis (UC), and 10.7% had IBD-unclassified. Among the children with CD, children 1-5 years of age had more isolated colonic disease (39.6%) compared with 6- to 10-year-olds (25.3%, P = .04), and 11- to 16-year-olds (22.3%, P < .01). The change from a presenting colon-only phenotype to ileocolonic began at 6-10 years. Children 1-5 years of age with CD had milder disease activity (45.8%) at diagnosis compared with the oldest group (28%, P = .01). Five years postdiagnosis, there was no difference in disease activity among the 3 groups. However, compared with the oldest group, a greater proportion of 1- to 5-year-olds with CD were receiving corticosteroids (P < .01) and methotrexate (P < .01), and a greater proportion of 1- to 5-year-olds with UC were receiving mesalamine (P < .0001) and thiopurine immunomodulators (P < .0002). Children with VEO-CD are more likely to have mild disease at diagnosis and present with a colonic phenotype with change to an ileocolonic phenotype noted at 6-10 years of age. Five years after diagnosis, children with VEO-CD and VEO-UC are more likely to have been administered corticosteroids and immunomodulators despite similar disease activity in all age groups. This may suggest development of a more aggressive disease phenotype over time.

A 24-month prospective study on the efficacy and safety of two different monthly regimens of vitamin D supplementation in pre-menopausal women with systemic lupus erythematosus.

Low vitamin D (vit.D) serum levels are common in patients with systemic lupus erythematosus (SLE) and seem to correlate with higher disease activity. We investigated the effects of different regimens of vit.D supplementation in SLE patients with inactive disease. This 24-month prospective study included 34 SLE women who were randomized to receive, together with their ongoing treatment, a standard regimen (SR) of cholecalcipherol (25,000 UI monthly) or an intensive regimen (IR) (300,000 UI initial bolus followed by 50,000 UI monthly) for one year and then were switched to the other regimen in the second year. Patients were seen quarterly for assessment of 25-OH vit.D levels, disease activity, SLE serology and bone metabolism markers. By intra-patient comparison, only the IR was found able to significantly raise vit.D serum levels. After 12 months, values above 30 ng/ml were found in 75% of patients in IR while in only 28% in SR. No significant differences in disease activity and SLE serology were found at any time point between SR and IR. No changes in the mineral metabolism were observed. The IR was safe and effective in obtaining sufficient levels of vit.D in most SLE patients. However, both regimens of supplementation did not differently affect disease activity nor SLE serology.

Relevance of congenital melanocytic naevi in vitiligo.

Some case reports concerning the concomitant presence of congenital melanocytic naevi (CMN), halo naevi and vitiligo have been published. However, their possible link has never been investigated in a large patient population. To evaluate the relevance of CMN in patients with vitiligo with respect to the presence of halo naevi and some general clinical variables such as age of onset, Koebner phenomenon and body surface area (BSA) involvement. In total, 1004 patients with vitiligo (nonsegmental) and 291 control patients were included in this observational study. CMN were scored in size, location and halo formation, and classified into clinical convincing or possible lesions. Convincing CMN were present in 3·3% of the patient population and in 1·0% of the control population. The presence of halo naevi was significantly higher (P=0·01) and age of onset of vitiligo was significantly lower (P<0·01) in the presence of CMN. Halo formation around the CMN, as observed in 30·3% of cases, was associated with a higher diameter of the CMN. Patients with congenital naevi had a particular predisposition to having lesions on joints/acral areas and reported more often signs of Koebner phenomenon (P=0·01). No clear difference in disease activity, BSA involvement, associated autoimmune diseases or treatment response was observed in patients with vitiligo with or without congenital naevi. This study provides clinical evidence that CMN may influence the age of onset of vitiligo and trigger the development of halo naevi in patients with vitiligo.