Effect Of Adalimumab Treatment Research Articles

Observational data from the adalimumab post‐marketing PYRAMID registry of patients with Crohn's disease who became pregnant: A post hoc analysis

BackgroundPYRAMID was an international post‐marketing registry that aimed to collect data on the long‐term safety and effectiveness of adalimumab treatment per local standard of care in patients with moderately to severely active Crohn's disease (CD). Here, we present post hoc analyses of observational data from patients who became pregnant while participating in this registry and receiving adalimumab.MethodsFrom the subpopulation of patients receiving adalimumab who became pregnant while taking part in PYRAMID, data on patient characteristics, pregnancy outcomes, and complications of pregnancy were analysed retrospectively.ResultsAcross the PYRAMID registry, 293 pregnancies occurred in patients who had gestational adalimumab exposure (average disease duration at last menstrual period: 8.6 years), resulting in 300 pregnancy outcomes. A total of 197 pregnancies (67.2%) were exposed to adalimumab in all trimesters per physician's decision. Of the known reported outcomes (96.3%), 81.7% (236/289) were live births, 10.4% (30/289) were spontaneous abortions, 4.8% (14/289) elective terminations, 2.8% (8/289) ectopic pregnancies, and 0.3% (1/289) was a stillbirth. Congenital malformations (pulmonary valve stenosis and tricuspid valve incompetence) were reported in one infant. In addition to the pregnancy outcomes described above, 23 complications of pregnancy were reported in 20 patients.ConclusionsThis analysis showed that adalimumab treatment in patients with CD, who became pregnant whilst participating in the PYRAMID registry, contributed no additional adverse effects during the pregnancy course or on pregnancy outcomes.

Long-term safety and effectiveness of adalimumab in Japanese patients with Crohn's disease: 3-year results from a real-world study.

Background/AimsCrohn’s disease is a chronic disorder; therefore, it is essential to investigate long-term safety and efficacy of treatments. This study assessed the safety and effectiveness of adalimumab for up to 3 years in Japanese patients with Crohn’s disease in real-world settings.MethodsThis was a multicenter, single-cohort, observational study of patients with Crohn’s disease. Safety assessments included incidence of adverse drug reactions. Effectiveness assessments included clinical remission, mucosal healing, and Work Productivity and Activity Impairment (WPAI).ResultsThe safety and effectiveness analysis populations comprised 389 and 310 patients, respectively. Mean (standard deviation) exposure to adalimumab in the safety analysis population was 793.4 (402.8) days, with a 58.1% retention rate. A total of 105 patients (27.0%) and 43 patients (11.1%) experienced adverse drug reactions and serious adverse drug reactions, respectively, with no patient reporting tuberculosis or hepatitis B. Infections and serious infections were reported in 37 patients (9.5%) and 17 patients (4.4%), respectively. Malignancy was reported as an adverse drug reaction in 2 patients (0.5%). Remission rate increased from 37.8% (98/259) at baseline to 73.9% (167/226) at week 4 and remained > 70% over 3 years. Proportion of patients without mucosal ulcerations increased from 2.7% (2/73) at baseline to 42.3% (11/26) between years > 2 to ≤ 3. WPAI improvement started at 4 weeks, with the overall work impairment score improving from 42.7 (n = 102) at baseline to 26.9 (n = 84) at 4 weeks.ConclusionsResults from this study confirm the long-term safety and effectiveness of adalimumab treatment in Japanese patients with Crohn’s disease in the real-world setting.

The Effect of Adalimumab Treatment on Linear Growth in Children With Crohn Disease: A Post-hoc Analysis of the PAILOT Randomized Control Trial.

Growth impairment is common in children with Crohn disease (CD). We aimed to assess the effect of adalimumab (ADL) treatment on linear growth in children with CD in a post-hoc analysis of the Pediatric Crohn's Disease AdalImumab Level-based Optimization Treatment randomized controlled trial. Children 6 to 17 years who responded to ADL induction were assessed consecutively for anthropometric parameters. Associations of these parameters with disease characteristics and disease activity were analyzed. Overall, 66 patients completed 72 weeks of follow-up (25% girls, mean age of 15.6 ± 2.5 years). Median (interquartile range [IQR]) height z score improved from -0.6 (-1.6-0.15) at baseline to -0.33 (-1.3-0.5) at week 72 (P = 0.005) with lesser improvement in patients with perianal disease. Similar effect was noted in children with growth potential (boys younger than 16 years, girls younger than 14 years). Median (IQR) height velocity standard deviation was -0.32 (-1.5-0.8) at week 26, and +0.11 (-1.1-1.3) at week 72. Median weight z score increased from -0.54 (-1.2-0.15) to -0.1 (-0.9-0.6), P < 0.001 and body mass index from -0.4 (-1.0-0.5) to 0.0 (-0.8-0.9), P = 0.005. Pediatric CD activity index and erythrocyte sedimentation rate at week 4 correlated negatively with height z score changes (P = 0.043 and P = 0.048, respectively), whereas sustained clinical and biologic remission (week 4-72) were positively associated with changes in height z scores. Significant improvement in linear growth was predicted by lower pediatric CD activity index and erythrocyte sedimentation rate at the end of induction and sustained clinical remission (P = 0.05) and sustained normal C-reactive protein (P = 0.001) at all visits. In children with moderate-to-severe CD, ADL treatment had a significant effect on linear growth, with normalization of weight and body mass index (clinicaltrials.gov no: NCT02256462).

A prospective, longitudinal monocentric study on laser Doppler imaging of microcirculation: comparison with macrovascular pathophysiology and effect of adalimumab treatment in early rheumatoid arthritis

Increased cardiovascular (CV) morbidity and mortality have been found in rheumatoid arthritis (RA). Tumour necrosis factor α (TNF-α) inhibitors may improve vascular function. In the first part of this study, we determined microcirculation during postoocclusive reactive hyperemia (PORH) representing endothelial function. In a nonselected population (n = 46) we measured flow-mediated vasodilation (FMD) of the brachial artery and laser Doppler flow (LDF) by ultrasound. Among LDF parameters, we determined TH1 (time to half before hyperemia), TH2 (time to half after hyperemia), Tmax (time to maximum) and total hyperemic area (AH). We measured von Willebrand antigen (vWF:Ag) by ELISA. In the second part of the study, we assessed the effects of adalimumab treatment on microcirculatory parameters in 8 early RA patients at 0, 2, 4, 8 and 12 weeks. We found significant positive correlations between FMD and LDF Tmax (R = 0.456, p = 0.002), FMD and TH2 (R = 0.435, p = 0.004), and negative correlation between vWF:Ag and Tmax (R = − 0.4, p = 0.009) and between vWF:Ag and TH2 (R = − 0.446, p = 0.003). Upon adalimumab therapy in early RA, TH2 times improved in comparison to baseline (TH2baseline = 26.9 s vs. TH24weeks = 34.7 s, p = 0,032), and this effect prolonged until the end of treatment (TH28weeks = 40.5, p = 0.026; TH212weeks = 32.1, p = 0.013). After 8 weeks of treatment, significant improvement was found in AHa (AHbaseline = 1599 Perfusion Units [PU] vs. AH8weeks = 2724 PU, p = 0.045). The PORH test carried out with LDF is a sensitive option to measure endothelial dysfunction. TH1 and TH2 may be acceptable and reproducible markers. In our pilot study, treatment with adalimumab exerted favorable effects on disease activity, endothelial dysfunction and microcirculation in early RA patients.

P598 Safety and effectiveness of adalimumab treatment in 1523 patients with ulcerative colitis: Results from a prospective, multi-centre, observational study

P598 Safety and effectiveness of adalimumab treatment in 1523 patients with ulcerative colitis: Results from a prospective, multi-centre, observational study

Effect of adalimumab treatment on metabolic parameters over 36 weeks: Integrated analysis from 2 phase 3 studies in patients with hidradenitis suppurativa

Effect of adalimumab treatment on metabolic parameters over 36 weeks: Integrated analysis from 2 phase 3 studies in patients with hidradenitis suppurativa

Effect of adalimumab treatment on metabolic parameters over 3 years: Integrated analysis from phase 2/3 clinical trials in patients with moderate to severe psoriasis

Effect of adalimumab treatment on metabolic parameters over 3 years: Integrated analysis from phase 2/3 clinical trials in patients with moderate to severe psoriasis

Benefits vs. side effects of Adalimumab treatment in Psoriasis/Psoriatic Arthritis

Benefits vs. side effects of Adalimumab treatment in Psoriasis/Psoriatic Arthritis

Five-year analysis from the ESPRIT 10-year postmarketing surveillance registry of adalimumab treatment for moderate to severe psoriasis

ESPRIT is an ongoing, 10-year, observational registry, evaluating long-term safety and effectiveness of adalimumab treatment in routine clinical practice for patients with moderate to severe, chronic plaque psoriasis. Initial 5-year results are reported. Two populations were analyzed: the "all-treated" population received 1 or more adalimumab dosesin registry, continuing adalimumab treatment from a current prescription or previous study participation, and included the "new-prescription" population initiating adalimumab 4weeks or earlier preregistry entry. Data were collected from September 26, 2008, through November 30, 2013, for all-treated (n=6059), which included new-prescription (n=2580, 42.6%); median registry exposure was 765 and 677days, respectively. In all-treated, rate (events per 100 patient-years of total adalimumab exposure [E/100PY]) of serious treatment-emergent adverse events (inside or outside of the registry) was 4.3E/100PY, serious infection 1.0E/100PY, malignancies 0.9E/100PY (nonmelanoma skin cancers 0.6E/100PY; melanomas <0.1E/100PY). Standardized mortality ratio was 0.30 (95% confidence interval 0.19-0.44). Physician Global Assessment clear or minimal (effectiveness parameter) was achieved by 57.0% at 12months and 64.7% at 60months of treatment. Observational data are subject to outcome-reporting bias. No new safety signals were observed with adalimumab treatment during this initial 5-year registry review. Observed number of deaths was below expected. As-observed effectiveness remained stable through 60months.

Depression Over Psoriasis: Assessment of associated Relief by addition of ADalimumab for the treatment of Psoriasis: Observational study (DORADO - Ps)

BackgroundPsoriasis is associated with a variety of psychological difficulties, including poor self-esteem, sexual dysfunction, anxiety, depression, and suicidal ideation. ObjectivesThe aim of this study was to obtain further data on the extent of depression among psoriatic patients, the effectiveness of adalimumab treatment on the depression symptoms associated with psoriasis and to explore the association between improvement in depression symptoms and improvement in Psoriasis Area and Severity Index. MethodsThe effects of adalimumab (40mg every other week) on ZDS score and PASI at week 24 were assessed. Relationships between ZDS and PASI were assessed. Changes in ZDS score were compared for patients with and without a 75% or greater reduction in baseline PASI score. An improvement of 6 points or more in the Zung depression scale was considered a clinically meaningful improvement. ResultsForty five Patients with moderate to severe psoriasis were assessed for depression symptoms at baseline and week 24 using the Zung Self-rating Depression Scale (ZDS). At month 6 after starting adalimumab, 80% of enrolled patients achieved 75% improvement in their PASI score (PASI75) at month 6 of adalimumab therapy and 97.8% achieved a meaningful improvement of Zung depression score (more than 6 points decline in the Zung depression score). Age at time of assessment significantly predicted depression (p=0∗030), with the younger age predicting a higher depression score (standard co-efficient -.451). Achieving PASI 75 could significantly predict improvement in depression (p=0.002, standard coefficient-.746). ConclusionAdalimumab may be associated with relief symptoms of depression in patients with moderate to severe psoriasis. Reductions in depression symptoms were significantly correlated with reductions in psoriasis severity.

Safety and effectiveness of adalimumab treatment in Japanese patients with psoriasis and psoriatic arthritis: All case postmarketing surveillance in Japan

Safety and effectiveness of adalimumab treatment in Japanese patients with psoriasis and psoriatic arthritis: All case postmarketing surveillance in Japan

Effect of adalimumab treatment on pruritus: A post-hoc analysis of the phase III, randomized REVEAL trial in patients with moderate to severe psoriasis

Effect of adalimumab treatment on pruritus: A post-hoc analysis of the phase III, randomized REVEAL trial in patients with moderate to severe psoriasis

A Prospective, Randomized, Placebo-Controlled Study to Identify Biomarkers Associated with Active Treatment in Psoriatic Arthritis: Effects of Adalimumab Treatment on Lesional and Nonlesional Skin

Background: There is a need for biomarkers to screen the effectiveness of (novel) therapeutic agents for psoriasis at an early stage. Objective: We aimed to determine which of the changes in psoriatic skin correlates best with clinical improvement 4 weeks after effective adalimumab therapy. Methods: Twenty-two psoriatic arthritis patients were randomized to receive adalimumab or placebo. T cell numbers and markers of innate immunity were estimated in lesional and nonlesional skin biopsies at baseline and after 4 weeks of treatment. Results: CD161+ and elastase+ dermal cells in lesional skin were significantly reduced upon 4 weeks of successful adalimumab treatment compared with placebo. Conclusion: Early improvement of psoriasis lesions during adalimumab therapy is associated with a marked reduction of infiltrated dermal CD161+ T cells and elastase+ neutrophils, suggesting that these parameters could be used as biomarkers to monitor early changes after active treatment in small proof-of-concept studies of short duration.

The effects of adalimumab treatment and psoriasis severity on self-reported work productivity and activity impairment for patients with moderate to severe psoriasis

Psoriasis significantly impairs work productivity and daily activities. We sought to examine the effects of adalimumab on psoriasis-related work productivity and activity impairment and associations between the impairment and psoriasis severity in patients with moderate to severe psoriasis. Data were from the first 16 weeks of the Randomized controlled EValuation of adalimumab Every other week dosing in moderate to severe psoriasis TriAL (REVEAL). Outcomes as measured by the Work Productivity and Activity Impairment Questionnaire for Psoriasis (WPAI-Psoriasis) included employment status, total work productivity impairment, and total activity impairment. Logistic regression and analyses of covariance were used to assess the effects of adalimumab and treatment response (≥ 75% improvement in Psoriasis Area and Severity Index responders) on WPAI-Psoriasis outcomes. Longitudinal generalized estimating equations and Pearson correlation coefficients were used to assess associations between WPAI outcomes and psoriasis severity. Greater improvements in total work productivity impairment and total activity impairment were observed with adalimumab treatment versus placebo (15.5 and 11.1 percentage points, respectively; P < .001). Unemployment rate, total work productivity impairment, and total activity impairment were significantly associated with greater baseline psoriasis severity. Changes in WPAI outcomes were significantly correlated with greater psoriasis severity. The Dermatology Life Quality Index had stronger associations with changes in WPAI outcomes compared with clinical severity measures (Psoriasis Area and Severity Index and Physician Global Assessment). REVEAL only included WPAI data for 16 weeks. Therefore, long-term impact of adalimumab treatment on productivity outcomes could not be assessed. In addition, information on occupational job title or industry was not collected and data were not adjusted for psoriatic arthritis. Adalimumab reduced psoriasis-related work productivity and activity impairment in patients with moderate to severe psoriasis.

THE FIRST RUSSIAN EXPERIENCE OF ADALIMUMAB TREATMENT IN PSORIATIC ARTHRITIS

Objective. To evaluated effect of adalimumab treatment on activity of arthritis, enthesitis, psoriasis and functional status in PsA patients (pts). Subjects and methods. 18 pts with active PsA (12 female, 6 male), median age 43,1±10,2 years (yrs) (range 24-56), median duration of psoriasis 16,7±9,6 yrs (range 4-33), median duration of PsA 9,2±6,7 yrs (range 1,5-23) received Adalimumab 40 mg subcutaneously every other week (wk) for 12 wks in open-label study. Evaluations of treatment effects were conducted by the PSARC, ACR 20, 50 and 70, LEI, PASI, BSA, HAQ and CRP at wks 4 and 12. Results. The sings of activity of PsA at baseline were: DAS=4,8 (4,0; 5,45), LEI=4,25 (0,25; 8,05), PASI=10,5 (7,2; 12,1), BSA=1,75 (1; 2), HAQ=1,125 (0,875; 1,5), СRР=27,9 (11,4; 34,6). After 4 wks all parameters significantly improved: DAS=2,85 (2,1; 3,1), LEI=1,86 (0; 3,97), PASI=6,4 (2,8; 8), BSA=0,75 (0,15; 1), HAQ=0,375 (0,125; 0,625), СRP=1,7 (1,4; 3,2) and were maintained after 12 wks: DAS=1,6 (1,3; 2,03), LEI=0,38 (0; 0,89), PASI=1,1 (0,4; 2,2), BSA=0 (0; 0,9), HAQ=0,312 (0; 0,625), СRР=1,75 (0,7; 3,6); p<0,05. 100% pts achieved PSARC at the 4 and 12 wks 55,6; 11,1 and 27,8% PsA pts achieved ACR 20, 50 and 70 at 4 wks and 11,1; 33,3 and 55,6% at 12 wks respectively. Adalimumab was well tolerated throughout the study. Conclusion. Adalimumab therapy significantly reduced the main clinical symptoms of PsA: arthritis, enthesitis, psoriasis. Additionally it improved quality of life PsA patients and was well tolerated.

W1261 Effect of Adalimumab Treatment on the Microbiota Recovery in the Intestinal Mucosa of Crohn's Disease Patients

W1261 Effect of Adalimumab Treatment on the Microbiota Recovery in the Intestinal Mucosa of Crohn's Disease Patients

A prospective, randomised, placebo-controlled study to identify biomarkers associated with active treatment in psoriatic arthritis: effects of adalimumab treatment on synovial tissue

Objective:To determine which of the changes in synovial tissue correlates best with clinical response associated with effective therapy (adalimumab) to facilitate the planning of future studies with therapeutic agents for...

The effect of adalimumab treatment for moderate to severe psoriasis on concurrent response for both psoriasis and psoriatic arthritis

The effect of adalimumab treatment for moderate to severe psoriasis on concurrent response for both psoriasis and psoriatic arthritis

P322 - A first experimental approach to the effect of adalimumab treatment on the microbial composition of the intestinal mucosa in Crohn's disease patients

P322 - A first experimental approach to the effect of adalimumab treatment on the microbial composition of the intestinal mucosa in Crohn's disease patients