Received Adalimumab Treatment Research Articles

Effect of adalimumab treatment on inflammatory and hematological parameters in patients with Hidradenitis suppurativa

Objective Hidradenitis suppurativa (HS), a chronic inflammatory disease that typically manifests after puberty, is characterised by painful nodules, abscesses, draining sinus tracts, and scars in areas rich in apocrine glands such as the axillary and inguinal regions. In recent years, blood-based biomarkers such as the Neutrophil/Lymphocyte Ratio (NLR), Platelet/Lymphocyte Ratio (PLR), Monocyte/Lymphocyte Ratio (MLR), Mean Platelet Volume (MPV), Systemic Immune-Inflammation Index (SII) and Pan-Immune-Inflammation Value (PIV) have been used as significant indicators of systemic inflammation. While there are few studies evaluating these biomarkers in HS, the response of these markers to treatment has only been assessed in one study to date. Our study aims to investigate the effect of adalimumab treatment on blood-based systemic inflammation biomarkers in HS, where inflammation plays a significant role. Methods The study included 42 adult patients who received adalimumab treatment at our dermatology and venereology clinic between January 2020 and January 2023. Medical records for complete blood count results of the patients were retrospectively reviewed. All systemic inflammation-based biomarkers were calculated from the absolute values of the complete blood count. The SII was calculated with the following formula: (neutrophil count × platelet count/lymphocyte count). The PIV was calculated as follows: (neutrophil count × platelet count × monocyte count/lymphocyte count). Values before the treatment and at the 12th week of treatment were compared. Results When the changes in the inflammatory parameters of the patients were examined, it was found that NLR (2.13 ± 0.87 vs 2.26 ± 1.12), PLR (111.01 ± 39.89 vs 99.43 ± 35.34), MLR (0.27 ± 0.11 vs 0.28 ± 0.12), MPV (9.59 ± 0.71 vs 9.70 ± 0.79), SII (680.79 ± 330.18 vs 687.89 ± 442.66), and PIV (552.02 ± 330.71 vs 605.05 ± 415.96) values did not change statistically significantly after treatment (p > 0.05). While there was a significant decrease in platelet count compared to before treatment, no statistically significant difference was found in the other evaluated blood cells. Conclusion Adalimumab treatment has not had a significant effect on systemic inflammation markers in HS, an inflammatory disease. More studies are needed to evaluate the effect of adalimumab on these markers in HS.

ASSESSMENT OF THE EFFICACY OF ADALIMUMAB TREATMENT IN HIDRADENITIS SUPPURATIVA: A SINGLE-CENTER STUDY

Hidradenitis suppurativa (HS), is a chronic disease characterized by recurrent subcutaneous nodules, abscesses, and draining sinuses. Adalimumab is used for moderate to severe HS cases that do not respond to systemic treatments. The aim of our study was to evaluate the efficacy of adalimumab treatment in patients with HS who received treatment at our clinic. The medical records of patients aged 18 years and older who received adalimumab treatment for HS between 2016 and 2021 were retrospectively reviewed. When patients were evaluated in terms of Hidradenitis Suppurativa Clinical Response (HISCR) at the end of 3 months, 6 (31.6%) patients had achieved HISCR within 3 months. After 6 months of treatment, an additional 9 (47.4%) patients had reached the HISCR endpoint. At the end of 6 months, no response was observed in 4 patients (21.1%). Based on the data obtained from the study, adalimumab is considered to be an effective and safe treatment method for moderate to severe HS patients.

Tumor Necrosis Factor-Alpha (+489 G/A) Polymorphism Can Predict the Response to Adalimumab in Chinese Han Patients With Ankylosing Spondylitis.

Studies investigating the association between single nucleotide polymorphisms (SNPs) of tumor necrosis factor-alpha (TNFα) and the efficacy of adalimumab (ADA) in ankylosing spondylitis (AS) therapy have reported conflicting results. We aimed to investigate the value of SNP typing of TNFα in predicting the efficacy of ADA in AS. Eighty patients with active AS who received ADA treatment were followed up for 24 weeks. Six known SNPs of TNFα (+489G/A, -238G/A, -308G/A, -857C/T, -863C/A, and -1031C/T) were subjected to the SNaPshot SNP typing method, which has been proven to be a reliable, efficient, and cost-effective method for detecting SNPs. The relationship between each SNP genotype and the therapeutic efficacy of ADA was analyzed. At the end of the 24-week follow-up, 58.8% of the patients with AS achieved Assessment of SpondyloArthritis International Society (ASAS) partial remission (PR), 67.5% of the patients achieved the criteria of an ASAS40response (40% improvement on indices), and 53.8% of the patients achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) major improvement (MI). The univariate analysis showed that patients with AS carrying the TNFα +489 A allele were more likely to achieve ASAS-PR, ASAS40 response criteria, and ASDAS-MI after ADA treatment. In the multivariate regression analysis, the TNFα +489 A allele was an independent factor influencing the efficacy of ADA in treating AS (ASAS-PR odds ratio (OR) = 2.66, 95% confidence interval (CI) = 1.01-7.01; ASAS40 OR = 4.56, 95% CI = 1.39-15.00; ASDAS-MI OR = 3.31, 95% CI = 1.02-10.69). The patients carrying the TNFα +489 A allele may be more likely to experience better therapeutic efficacy and achieve the treatment target (ASAS-PR, ASAS40 response, or ASDAS-MI) after receiving ADA treatment. Detection of TNFα +489 G/A may predict the therapeutic efficacy of ADA, which can be used in clinical practice to tailor treatment for individual patients with AS. Further studies with larger sample sizes and longer follow-up periods with imaging evaluation are needed to verify our findings.

Impact of Single Nucleotide Polymorphisms of the Promoter of the TNF Gene on Adalimumab Treatment Responses in Hidradenitis Suppurativa

Background: Results of randomized clinical trials show great variation in response to treatment with adalimumab (ADA) in hidradenitis suppurativa (HS). This varied response may be associated with genetic polymorphisms. Objectives: The aim of the study was to study the association between carriage of single nucleotide polymorphisms (SNPs) in the promoter of the tumor necrosis factor (TNF) gene and their response to ADA. Methods: Patients with moderate to severe HS who received ADA treatment for at least 12 weeks were enrolled. SNPs were analyzed with PCR-restriction fragment length polymorphism. Hidradenitis Suppurativa Clinical Response (HiSCR) score, International Hidradenitis Suppurativa Severity Scoring System 4 (IHS4) score, inflammatory lesion (AN) count, and draining tunnel (dT) count were collected at weeks 0, 12, 24, 36, and 48. Results: HiSCR response after 12 weeks of ADA treatment was 71.8% among carriers of the common GGG haplotype and 50.0% among carriers of minor frequency SNP haplotypes (p: 0.031; odds ratio: 0.39). This significant difference persisted until week 36. Carriers of minor frequency SNP haplotypes also had a lower relative decrease of the AN count at weeks 12 and 24; the dT count and IHS4 were not statistically different between the two groups. Conclusions: Carriage of at least one minor frequency SNP haplotype of the promoter of the TNF gene is associated with a decreased response to ADA. This association may have an impact on treatment decision-making.

Adalimumab treatment for chronic recurrent Vogt-Koyanagi-Harada disease with sunset glow fundus

We investigated the efficacy and safety of adalimumab (ADA) treatment for chronic recurrent Vogt-Koyanagi-Harada (VKH) patients with sunset glow fundus (SGF). Medical records of 50 chronic recurrent VKH patients with SGF who received ADA treatment for more than 6 months were retrospectively reviewed. The mean age of chronic recurrent VKH patients with SGF was 55.9 ± 14.4 years, and the male/female ratio was 26/24. Before ADA treatment, the mean daily dose of systemic corticosteroids was 16.5 ± 12.7 mg, and 22 patients (44%) were under immunosuppressors. LogMAR visual acuity (VA), flare counts, subfoveal choroidal thickness (SFCT), indocyanine green angiography scores, and corticosteroid and cyclosporine doses were significantly reduced by ADA treatment at 6 months compared to baseline. Among all parameters, flare count was significantly related to LogMAR VA. LogMAR VA was significantly related to flare counts but not to SFCT nor to ICGA scores. ADA treatment was continued in 94%. ADA was shown to be effective in achieving remission of chronic recurrent VKH disease with SGF refractory to conventional treatments, and was generally well tolerated with few serious adverse events.

Efficacy and Safety of Adalimumab for Exacerbation or Relapse of Ocular Inflammation in Patients with Vogt-Koyanagi-Harada Disease: A Multicenter Study

ABSTRACT Purpose We investigated efficacy and safety of adalimumab (ADA) treatment for exacerbation or recurrence of Vogt-Koyanagi-Harada (VKH) patients. Methods Medical records of 70 VKH patients who received ADA treatment for more than 6 months were retrospectively investigated. Results The mean age of VKH patients was 54.8 ± 15.1 years, and male/female ratio was 34/36, and sunset glow fundus was observed in 71.4%. Subfoveal choroidal thickness, indocyanine green angiography scores, and corticosteroid and cyclosporine doses were significantly reduced by ADA treatment for 6 months compared to baseline, while LogMAR and flare counts were also improved without being statistically significant. Adverse events were observed in 17.1%, in which tuberculosis was at 7.14% and psoriasis was at 2.86%; however, ADA treatment was continued in 91.4%. Conclusions ADA was shown to be effective to achieve remission of VKH disease refractory to conventional treatments and was generally well tolerated with few serious adverse events.

Efficacy and safety of adalimumab in treating patients with moderate to severe plaque psoriasis: a retrospective study

<p class="abstract"><strong>Background:</strong> Psoriasis is a disease of systemic inflammation with multiple organ ramifications. It is a chronic, painful, non-communicable, immune-mediated, genetic disease-causing disfiguration and disability, for which there is no cure and with great negative impact on patients’ quality of life (QoL). Aim and objective was to assess the efficacy and safety of adalimumab (ADA) in moderate to severe plaque psoriasis.</p><p class="abstract"><strong>Methods:</strong> A hospital based, analytical retrospective observational study was conducted among patients aged 18 years and above, irrespective of gender and who received adalimumab treatment for moderate-to-severe plaque psoriasis and attended the outpatient clinic of dermatology at a tertiary care hospital for a period of 12 months. Efficacy was evaluated in all patients at 4, 12 and at last visit by calculating PASI (psoriasis area and severity index) relative to pre-treatment visit (baseline 0 week) as there was no comparative group. Safety was assessed by recording of side effects if any. Data was entered in MS excel 2019 and statistical analysis was done using SPSS 23 demo version.<strong></strong></p><p class="abstract"><strong>Results:</strong> The mean PASI score at 0 week was 24.4±3.26, this when compared to PASI score at 4 weeks (11.2±4.08), at 12 weeks (3.2±2.40), at 52 weeks (0.5±0.96) had shown an extreme statistically significant difference. Side effects reported were urticaria, diarrhea, upper respiratory tract infections.</p><p class="abstract"><strong>Conclusions:</strong> Adalimumab was very effective for chronic psoriasis, when given at high loading dose followed by maintenance dose every other week with minimal side effects.</p><p class="abstract"> </p><p align="left"> </p>

The risk of tuberculosis infection in 410 Saudipatients receiving adalimumab therapy.

BACKGROUND: Adalimumab is a fully humanized monoclonal antibody inhibitor of tumor necrosis factor-a used to treat various autoimmune disorders. Adalimumab poses a risk for tuberculosis (TB) infection, especially in countries where TB is endemic.OBJECTIVE: Determine the rate of TB infection after adalimumab therapy in Saudi Arabia.DESIGN: Medical record review.SETTINGS: Tertiary care center in Riyadh.PATIENTS AND METHODS: Demographic and clinical data were retrieved from the electronic healthcare records of all patients who received adalimumab treatment from 2015 to 2019.MAIN OUTCOME MEASURES: Occurrence of TB after adalimumab therapy.SAMPLE SIZE: 410 patients (median ([QR] age, 37 [28], range 4–81 years), 40% malesRESULTS: Rheumatoid arthritis was the most frequent indication (n=153, 37%). The patients were followed for a mean of 36 (8.9) months. No case of TB infection or reactivation was observed. An inter-feron-gamma release assay (IGRA) was requested in 353/391 (90.3%) patients, prior to initiating therapy. The IGRA was positive in 26 cases (6.6%). The IGRA-positive patients received isoniazid prophylactically. Bacterial infectious complications of adalimumab therapy occurred in 12 (2.9%) patients. Urinary tract infection was the most frequent complication (culture requested in 48 patients, positive in 8).CONCLUSION: Adalimumab treatment was not associated with a risk of TB disease or TB reactivation in our cohort over the follow-up observation period. No TB reactivation occurred with adalimumab therapy when TB prophylaxis was used. The positive IGRA rate in patients on adalimumab treatment was low (7%).LIMITATIONS: Single center and one geographical area in Saudi Arabia.CONFLICT OF INTEREST: None.

Cost of Illness, Quality of Life, and Work Outcomes in Active Ankylosing Spondylitis Patients Treated With Adalimumab in China.

Objectives: To access the cost of illness, quality of life and work limitation in active ankylosing spondylitis (AS) patients using adalimumab in China.Methods: A prospective study was performed in 91 patients with active AS in China. Adult patients (aged ≥ 18 years) fulfilled the 1984 New York modified criteria of AS with the Bath Ankylosing Spondylitis Disease Activity Index ≥ 4 were enrolled. All participants received adalimumab (40 mg per 2 weeks) therapy and completed questionnaires about disease characteristics, quality of life and cost. Only patients with pay-work completed the Work Limitation Questionnaire and Work productivity and activity impairment questionnaire in AS. Factors associated with work outcomes were evaluated.Results: A total of 91 patients with mean age of 30 years old (87.8% males) and mean disease duration of 10 years received adalimumab treatment for 24 weeks. The annual estimated cost of each patient was $37581.41 while the direct cost accounted for 84.6%. Seventy-eight percent of patients have a paid job with average work productivity loss of 0.28 measured by work limitation questionnaire, absenteeism and presenteeism were 10.22 and 43.86%, respectively, with a mean work productivity loss of 47.92% measured by Work productivity and activity impairment questionnaire in AS. Patients experienced significantly greater improvements after adalimumab treatment in presenteeism, absenteeism, work productivity, and quality of life.Conclusions: The cost of AS patients with adalimumab therapy was high in China. Disease activity, physical function, quality of life, and work outcomes improved significantly after therapy.

Circulating Retinol-Binding Protein 4 as a Possible Biomarker of Treatment Response for Ankylosing Spondylitis: An Array-Based Comparative Study.

ObjectiveTo explore proteins associated with ankylosing spondylitis (AS) and to investigate potential proteins that may predict treatment response of adalimumab (ADA) in AS patients.MethodsIn the discovery cohort, 39 AS patients and 20 healthy controls (HCs) were included, and 16 AS patients received ADA treatment for 24 weeks after included. In the validation cohort, 43 AS patients and 39 HCs were enrolled, and all 43 patients received ADA treatment after enrollment. Blood samples and clinical information were collected from two cohorts at baseline from all participants and week 24 from patients received ADA treatment. A human antibody array containing 1,000 proteins was used in the discovery phase, and Elisa kits were used for protein validation.ResultsCompared with HCs, we identified 53 differentially expressed proteins (DEPs) in AS patients. Bioinformatics analysis revealed they were mostly enriched in coagulation function-related pathways, acute response signaling, and LXR/RXR activation. Bone metabolism pathways were also associated. Comparison between samples of pre- and post-ADA treatment revealed 42 DEPs. They were mostly associated with bone metabolism and inflammation response pathways. Significant enrichment was also found in LXR/RXR activation but not the coagulation function-related pathways. Upstream regulator analysis suggested that most regulators also significantly functioned under usage of ADA. Precisely, seven proteins were abnormally expressed in AS and restored after ADA treatment. Retinol-binding protein 4 (RBP4), one of the seven proteins, was validated that its baseline levels were inversely correlated with improvements in Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP). Likewise, percentage changes in RBP4 levels were inversely correlated with changes in ASDAS-CRP score.ConclusionA dysregulated serum protein profile existed in AS. ADA exerted a considerable but not entire alteration toward the dysregulation. RBP4 could be a biomarker for predicting and monitoring ADA treatment response.

Monitorization of tuberculosis screening tests during anti-TNF- and #945; treatment in children with rheumatic diseases

Aim: We aimed to investigate the incidence of latent tuberculosis infection (LTBI) and seroconversion rate of LTBI screening tests under anti-TNF-α treatment, in our pediatric patients with chronic rheumatic diseases.Material and Methods: The data of 47 patients received anti-TNF-α treatment for different chronic rheumatic diseases between May-2015 and May-2018, were reviewed retrospectively. Demographics and clinical findings of the patients, as well as the treatments and their durations, were collected. The tuberculin skin test (TST) and Quantiferon-TB-Gold in-tube (QFT) test results at initiation and one year after the anti-TNF-α treatment were compared. Results: The study group included 38 (80.8%) patients with juvenile idiopathic arthritis, six (12.7%) with idiopathic uveitis, two (4.2%) with Behcet's disease related uveitis and one (2.1%) with juvenile dermatomyositis. For a period at least one year, 33 (70.2%) patients received etanercept, 12 (25.5%) received infliximab and two (4.2%) received adalimumab treatment. Before anti-TNF-α treatment, 31.9% of the patients were diagnosed with LTBI. After one year of treatment, it was found to be increased to 44.6%. During treatment, the seroconversion rate of the screening tests for LTBI was determined to be 12.7% (6/47).Conclusion: The seroconversion rate of screening tests for LTBI was found high in pediatric patients receiving anti-TNF-α treatment. Although the consistency between TST and QFT tests was found weak in our study, the fact that these tests should be used and evaluated together in the follow-up in the light of current guidelines in terms of LTBI and active tuberculosis development, remains still up to date. Further research is need in order for more enlightening data on the risk of LTBI and active tuberculosis in patients under anti-TNF-α treatment.

ADALIMUMAB THERAPY FOR REFRACTORY BIRDSHOT CHORIORETINOPATHY.

To report the outcome of using adalimumab to treat birdshot chorioretinopathy. Retrospective case series of 19 patients (38 eyes) with HLA-A29-positive birdshot chorioretinopathy who received adalimumab treatment. Patients had been refractory to previous standard systemic immunomodulatory therapy. They received biweekly subcutaneous injections of 40 mg of adalimumab. Outcome measures were change in visual acuity, fluorescein angiography, and optical coherence tomography features, the concomitant use of immunosuppressive drugs, and the occurrence of adverse effects between 1 year before, at baseline, and after 1 year of adalimumab treatment. Mean Snellen visual acuity at 1-year follow-up was 20/28, an improvement from 20/43 at the start of the treatment (P = 0.011) and equal to the visual acuity 1 year before the treatment (20/29). Only 2 of the 9 patients who had complete fluorescein angiography and optical coherence tomography results after the 1 year of treatment were completely free of inflammation signs at the end of the follow-up. Half (53%) of 17 patients were receiving adalimumab monotherapy after 1 year of treatment, an increase from 21% at the start of treatment (P = 0.047). Three of the 19 patients reported possible side effects; 2 discontinued treatment within 1 year. The results suggest that adalimumab is effective at improving visual acuity and at tapering concomitant immunomodulatory therapy, in patients with refractory birdshot chorioretinopathy. However, complete remission is rarely achieved.

Validation of a population pharmacokinetic model of adalimumab in a cohort of patients with inflammatory bowel disease.

therapeutic monitoring of anti-TNF drugs and anti-drug antibody levels are useful for clinical decision-making, via the rationalization and optimization of the use of anti-TNF treatments. The objective of the present study was to validate the model of Ternant et al., in a cohort of patients with inflammatory bowel diseases (IBD). This model was originally established for patients with rheumatoid arthritis and was used in this study to optimize the adalimumab (ADA) dose and predict ADA trough levels (ATL). this study used concentration data points from 30 IBD patients who received ADA treatment between 2014 and 2015. A goodness-of-fit of the model was determined by evaluating the relationship between the observed ATL values and population model-predicted values (PRED) or individual model-predicted values (IPRED). a total of 51 ADA concentration points were analyzed. The bias of the model was 2.39 (95% CI, 1.63-3.15) for PRED and 0.63 (95% CI, 0.23-1.03) for IPRED. The precision was 3.57 (95% CI, 2.90-4.13) and 1.53 (95% CI, 1.22-1.80), respectively. therapeutic drug monitoring involving ATL may allow the optimization of the treatment of IBD patients. The validation results of the phamacokinectic (PK) model for ADA in IBD patients are inadequate. However, additional studies will strengthen the bias and precision of the model.

Pregnancy Outcomes of Patients Exposed to Adalimumab in Japan

Background: This is the first retrospective report of pregnancy outcomes after exposure to adalimumab treatment in Japan. Methods: Using the AbbVie safety database, we analyzed pregnancy outcome data from patients who received adalimumab treatment from April 16, 2008, to May 15, 2017. Results: Data were extracted retrospectively for 74 pregnancies in 73 patients. More than half of the patients included in the study received adalimumab for the treatment of Crohn’s disease (37.8%) or ulcerative colitis (20.3%), while 9.5% received adalimumab for rheumatoid arthritis. Of the 53 pregnancies with available outcome data, 45 newborns (45/53 [84.9%]) were delivered. Of these births, 30 were full-term, 2 were preterm, and 13 were unknown. Apgar scores were available for 11 of the 16 newborns whose mothers were exposed to adalimumab in the third trimester; all scores were within the normal range. Low birth weight was observed in 5 infants out of the 30 full-term deliveries. There were also 5 miscarriages (5/53 [9.4%]), 2 induced abortions (2/53 [3.8%]), and 1 stillbirth (1/53 [1.9%]). Eight maternal adverse events were observed in 5 pregnancies; no serious adverse events occurred. Conclusion: Although safety concerns were inconclusive, these data do not report additional risk to pregnancy outcomes with adalimumab exposure.

P048 HISTORY OF CYTOMEGALOVIRUS COLITIS IS ASSOCIATED WITH POOR LONG-TERM OUTCOMES IN ADALIMUMAB THERAPY IN KOREAN PATIENTS WITH ULCERATIVE COLITIS: A HOSPITAL-BASED COHORT STUDY

Studies regarding long-term outcomes of adalimumab treatment in non-Caucasian patients with ulcerative colitis (UC) are still lacking. We analyzed long-term outcomes of Korean UC patients on adalimumab treatment in Asan Medical Center, Korea. Between July 2013 and June 2017, adalimumab treatment was commenced on in 72 patients; 49 males (68.1%), median age 40.5 years (Interquartile range [IQR], 24.25–50.00), and median disease duration 39.5 months (IQR, 22.00–85.00) at initiation of adalimumab. Twelve patients (16.7%) had a history of cytomegalovirus colitis within 3 months prior to starting adalimumab. Median duration of adalimumab therapy was 10.50 months (IQR, 2.00–26.75). Seventeen out of 72 patients (23.6%) were primary non-responders, and 7 out of those (9.7%) finally received colectomy. Out of 55 patients who received scheduled adalimumab maintenance therapy, 9 (16.4%) and 3 (5.5%) stopped adalimumab treatment due to loss of response and patients’ preference for discontinuation/loss to follow-up, respectively. Adalimumab dose intensification was required in 22 (40.0%) and corticosteroid rescue therapy was needed in 15 (27.3%) out of 55 patients during adalimumab maintenance therapy. The cumulative proportion of patients without adalimumab discontinuation was 61.0% at 1 year and 56.5% at 3 years among 72 patients who received adalimumab treatment more than once, and 80.1% at 1 year and 74.1% at 3 years among 55 patients who received adalimumab maintenance therapy. History of cytomegalovirus colitis within 3 months prior to starting adalimumab treatment was turned to be a predictor of adalimumab discontinuation (hazard ratio, 3.976; 95% confidence interval, 1.149–13.755; p = 0.029). Long-term outcomes of adalimumab treatment in Korean UC patients appears to be comparable to Western studies. Furthermore, a recent history of cytomegalovirus colitis was a predictor for adalimumab discontinuation.

P048 HISTORY OF CYTOMEGALOVIRUS COLITIS IS ASSOCIATED WITH POOR LONG-TERM OUTCOMES IN ADALIMUMAB THERAPY IN KOREAN PATIENTS WITH ULCERATIVE COLITIS: A HOSPITAL-BASED COHORT STUDY

Studies regarding long-term outcomes of adalimumab treatment in non-Caucasian patients with ulcerative colitis (UC) are still lacking. We analyzed long-term outcomes of Korean UC patients on adalimumab treatment in Asan Medical Center, Korea. Between July 2013 and June 2017, adalimumab treatment was commenced on in 72 patients; 49 males (68.1%), median age 40.5 years (Interquartile range [IQR], 24.25-50.00), and median disease duration 39.5 months (IQR, 22.00-85.00) at initiation of adalimumab. Twelve patients (16.7%) had a history of cytomegalovirus colitis within 3 months prior to starting adalimumab. Median duration of adalimumab therapy was 10.50 months (IQR, 2.00-26.75). Seventeen out of 72 patients (23.6%) were primary non-responders, and 7 out of those (9.7%) finally received colectomy. Out of 55 patients who received scheduled adalimumab maintenance therapy, 9 (16.4%) and 3 (5.5%) stopped adalimumab treatment due to loss of response and patients’ preference for discontinuation/loss to follow-up, respectively. Adalimumab dose intensification was required in 22 (40.0%) and corticosteroid rescue therapy was needed in 15 (27.3%) out of 55 patients during adalimumab maintenance therapy. The cumulative proportion of patients without adalimumab discontinuation was 61.0% at 1 year and 56.5% at 3 years among 72 patients who received adalimumab treatment more than once, and 80.1% at 1 year and 74.1% at 3 years among 55 patients who received adalimumab maintenance therapy. History of cytomegalovirus colitis within 3 months prior to starting adalimumab treatment was turned to be a predictor of adalimumab discontinuation (hazard ratio, 3.976; 95% confidence interval, 1.149-13.755; p = 0.029). Long-term outcomes of adalimumab treatment in Korean UC patients appears to be comparable to Western studies. Furthermore, a recent history of cytomegalovirus colitis was a predictor for adalimumab discontinuation.

Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial.

Background/AimsIntestinal Behçet's disease (BD) is an immune-mediated inflammatory disorder. We followed up the patients and evaluated safety profile and effectiveness of adalimumab for the treatment of intestinal BD through 100 weeks rolled over from the 52 week clinical trial (NCT01243671).MethodsPatients initiated adalimumab therapy at 160 mg at week 0, followed by 80 mg at week 2, followed by 40 mg every other week until the end of the study. Long-term safety and all adverse events (AEs) were examined. The efficacy was assessed on the basis of marked improvement (MI) and complete remission (CR) using a composite efficacy index, which combined global gastrointestinal symptoms and endoscopic assessments.ResultsTwenty patients were enrolled in this study; 15 patients received adalimumab treatment until study completion. The incidence of AEs through week 100 was 544.4 events/100 person-years, which was comparable to the incidence through week 52 (560.4 events/100 person-years). No unexpected trend was observed and adalimumab was well tolerated. At weeks 52 and 100, 60.0% and 40.0% of patients showed MI, respectively, and 20.0% and 15.0% of patients showed CR, respectively.ConclusionsThis report demonstrates 2 years safety and effectiveness of adalimumab in intestinal BD patients. Patients with intestinal BD refractory to conventional treatment receiving up to 2 years of adalimumab treatment demonstrated safety outcomes consistent with the known profile of adalimumab, and the treatment led to sustained reduction of clinical and endoscopic disease activity.

A2.7 Concomitant transverse myelitis and guillain-barre syndrome after adalimumab therapy in a case with ankylosing spondylitis

BackgroundThe introduction of TNF inhibitors into clinical practice has revolutionalised the treatment of most inflammatory diseases. However, these drugs are associated with various and potentially serious side effects. Despite being...

Gastroparesis and Ischemic Gastric Ulcers in a Patient with Rheumatoid Arthritis Receiving Adalimumab Treatment

Case: A 57-year-old woman with rheumatoid arthritis (treated with adalimumab for the past 8 years) presented with 6 months history of left sided abdominal pain, nausea, vomiting, 15 pounds in 6 months, painless numbness in her feet, orthostatic hypotension and sweating. She did not have active joint symptoms. A 4-hour gastric emptying was low (50 %;normal: 84-98%). Upper endoscopy revealed multiple gastric ulcers and mottled appearing duodenum with biopsies showing ischemia. Ultrasound with Doppler, MRI and CT scan of the abdomen were unremarkable with no evidence of mesenteric artery stenosis. Electromyography demonstrated axonal sensorimotor peripheral neuropathy (PN). This finding was not consistent with PN from rheumatoid vasculitis. Autonomic reflex testing revealed autonomic dysfunction with impairment in cardiovagal and adrenergic function. The work-up for metabolic causes and malignancy associated PN were negative. She was diagnosed with PN with an autonomic component and gastroparesis. It was thought that adalimumab may have caused the autonomic neuropathy which manifested as gastroparesis and ischemic ulcers of the upper gut. The adalimumab was stopped. Her symptoms that she previously had, such as sweating with epigastric pain and weight loss, had improved. Follow-up endoscopy 3 months later showed resolution of gastric ulcers and repeat biopsies were normal and negative for ischemia. Discussion: Neurological events associated with adalimumab are exceedingly rare, developed in 0.1% of patients. To our knowledge, our case is the first reported of autonomic neuropathy, gastroparesis and ischemic gastric ulcers with adalimumab use. In the absence of mesenteric stenosis, we postulate that the ischemia was caused by hypotension secondary to autonomic insufficiency. Most cases of drug-induced PN improve over a period of months after withdrawal of TNF- α antagonists. This case highlights the importance of monitoring for symptoms and signs of neurologic disease in patients being treated with TNF-α antagonists.

Adalimumab effectiveness for the treatment of ankylosing spondylitis is maintained for up to 2 years: long-term results from the ATLAS trial

Objective:To determine the long-term effect of adalimumab on patients with ankylosing spondylitis (AS) who participated in the Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS (ATLAS), a randomised, double-blind,...