Adalimumab Therapy Research Articles

Effect of adalimumab on choroidal thickness and choroidal vascularity index in eyes with non-infectious uveitis using enhanced-depth imaging optical coherence tomography

ObjectiveTo evaluate the effect of adalimumab (ADA) on choroidal thickness (ChT) and choroidal vascularity index (CVI) in eyes with non-infectious uveitis (NIU).MethodsThirty-seven eyes with NIU including Behçet disease (BD), sarcoidosis, ankylosing spondylitis (AS), juvenile idiopathic arthritis and idiopathic arthritis, 38 eyes of non-uveitic (NU) patients including BD, AS and rheumatoid arthritis, and 40 healthy control eyes were included. ADA was used for anti-TNF-naive adult (80 mg) or paediatric (40 mg) patients with refractory NIU, then 40 mg every 2-week (20 mg in children<30 kg) with controls at weeks 1, 4, 12, and 24. Images were used to measure central, nasal, and temporal ChT, and the luminal area (LA), stromal area, and total choroidal area (TCA) were analysed using enhanced-depth imaging optical coherence tomography (EDI-OCT) by ImageJ software. The CVI was then calculated as the ratio of LA to TCA.ResultsMean ages were similar between the groups. Mean (SE) subfoveal ChT measurements for each location were also similar (for each, p > 0.05). However, calculated CVI values in eyes with NIU (0.63 ± 0.007) were significantly (p < 0.001) lower than NU eyes (0.66 ± 0.006) and controls (0.70 ± 0.007) (p < 0.001). Moreover, CVI was significantly lower in NU eyes compared to controls (p < 0.001). There were no significant CVI changes between the consecutive visits after ADA therapy in eyes with NIU (for each, p > 0.05).ConclusionsDecreased CVI in NIU and NU eyes indicates that systemic inflammation affects the choroidal vasculature and perfusion both in the presence and absence of ocular involvement. Although CVI may be used as a possible novel tool in monitoring ocular involvement and progression of NIU, CVI does not seem to be a biomarker for treatment monitoring in NIU.

A229 DRUG PERSISTENCE WITH THERAPY OF ADALIMUMAB BIOSIMILAR, IDACIO, IN INFLAMMATORY BOWEL DISEASES

Abstract Background For post marketed medicine, drug persistence could be used as an indication for effectiveness and safety in routine clinical care over time. Non-adherence and non-persistence to treatment are associated with disease flares and may lead to disease progression among patients with inflammatory bowel diseases (IBD) in real-life. Aims The aim of this analysis was to explore drug persistence with an adalimumab biosimilar, Idacio, in IBD patients using the data collected by Fresenius Kabi patient support program (KabiCare) in Canada. Methods Patients with IBD enrolled in KabiCare and received at least one dose of adalimumab biosimilar, Idacio, were followed up from February 2021 to September 2023 in Canada. Medication initiation date and stop date, disease types (Crohn’s disease [CD], and ulcerative colitis [UC]) and patient treatment (categorized by naïve to biologic,or switched from other biologics) were recorded in the database. The stop date was the date when KabiCare was informed that medication was discontinued. The patients continuing medication were censored at the maximal follow-up date of analysis, September 12, 2022. Log-rank tests were used for KM (Kaplan-Meier) plot comparison to examine if there were differences in medication adherence between CD and UC, and between naïve group vs. switch group by disease. Results The study sample consisted of 1049 patients: 830 (79.1%) had CD, and 338 (32.2%) were in naïve group. KabiCare followed patients with CD for a median time of 512 days (interquartile range: 285-673 days; maximum: 895 days), and followed patients with UC for a median time of 492 days (interquartile range: 183-672 days; maximum: 925 days). At 800 days after starting the medicine, the drug persistence probability was similar for patients with CD and UC (At day-800: 76.6% vs. 67.6%, p=0.07). Among patients with CD, the drug persistence probability was higher in the switch group compared to naïve group (At day-800: 78.9% vs. 71.7%, p=0.0028). Among patients with UC, the drug persistence probably was similar in the switch group compared to naïve group (At day-800: 78.4% vs. 62.3%, p=0.34). Conclusions The drug persistence of adalimumab biosimilar, Idacio, was over 76% in patients with CD and over 67% in patients with UC 800 day after therapy initiation. Compared to patients in the naïve group, patients in the switch group were more likely to stay on adalimumab therapy. Funding Agencies None

Long-term efficacy, safety, and cumulative retention rate of antitumor necrosis factor-alpha treatment for patients with Behcet's uveitis: A systematic review and meta-analysis.

This study aims to evaluate the long-term efficacy, safety, and cumulative retention rate of antitumor necrosis factor-alpha (anti-TNF-α) therapy for patients with Behcet's uveitis (BU) using meta-analysis. We searched the Web of Science and PubMed databases for eligible studies up to December 1, 2022. The quality of each identified study was assessed using the Joanna Briggs Institute's case series literature quality assessment tool. Statistical analysis was conducted using Stata 16.0 software with a random-effects model. Twelve studies comprising 1156 patients with BU were included in our analysis. We found that 85.0% of patients achieved ocular inflammation remission after receiving anti-TNF-α treatment, with a 95% confidence interval (CI) ranging from 78.7% to 90.5%. Additionally, 77.4% (95% CI: 57.5%-92.5%) experienced an improvement in visual acuity (VA). Moreover, the pooled dose reduction of glucocorticoids (GCs) was 11.08 mg (95% CI: -13.34 mg to -8.83 mg). Throughout the follow-up period, the cumulative retention rate of the medication was 67.3% (95% CI: 53.7%-79.6%). Serious adverse events occurred in 5.8% (95% CI: 3.1%-8.9%) of cases, with the three most common types being severe infusion or injection reactions (2.7%; 95% CI: 0.8%-5.4%), tuberculosis (1.3%; 95% CI: 0.0%-3.9%), and bacterial pneumonia (1.3%; 95% CI: 0.1%-3.4%). Subgroup analysis revealed that ocular inflammation remission rates were 89.3% (95% CI: 81.2%-95.5%) for adalimumab treatment and 83.7% (95% CI: 75.3%-90.8%) for infliximab treatment. The drug retention rate after adalimumab therapy was 70.3% (95% CI: 62.0%-78.0%) compared to 66.4% (95% CI: 48.6%-82.2%) for infliximab treatment. Furthermore, the incidence of severe infusion or injection reactions was 2.2% (95% CI: 0.1%-5.8%) following adalimumab treatment and 3.5% (95% CI: 0.7%-7.7%) following infliximab treatment. Anti-TNF-α therapy represents an effective treatment for BU patients with favorable safety profile and high drug retention rate and a potential advantage of adalimumab over infliximab in terms of ocular inflammation remission, drug retention, and the incidence of severe infusion or injection reactions.

P468 Relevance of anti-drug antibodies in context of supra-therapeutic anti-TNF concentrations

Abstract Background The low serum concentration of anti-tumor necrosis factor-alpha (anti-TNFα) agents and the presence of anti-drug antibodies are related to poor therapeutic outcomes in inflammatory bowel disease (IBD). We aimed to evaluate the prognosis of patients having both antidrug antibodies and supratherapeutic drug concentrations. Methods IBD patients on maintenance infliximab (IFX) or adalimumab (ADA) therapy were prospectively recruited. Serum drug concentrations and antidrug antibodies were measured (Anser, Prometheus). The drug concentrations were classified as subtherapeutic (IFX: &amp;lt;3 µg/mL; ADA: &amp;lt;5 µg/mL), therapeutic (IFX: 3-8 µg/mL; ADA 5-10 µg/mL), and supratherapeutic (IFX &amp;gt; 8 µg/mL; ADA &amp;gt; 10 µg/mL) concentrations regardless of the timing of blood sample collection. We analysed the relationship between i) drug concentrations and ii) the presence and absence of anti-drug antibodies with use of systemic corticosteroids and anti-TNF discontinuation. Results Of 172 patients (122 CD [70.9%], 44 UC [25.6%], 3 IBD-U [1.7%], and 3 IBD-pouch [1.7%]), the median age was 32.3 years (range, 24.8-42.5), and the median duration of IBD was 9.7 years (range 5.3-15.6). IFX and ADA were used in 81 (47.1%) and 91 (52.9%) patients, respectively, and concurrent usage of immunomodulators and systemic corticosteroids was observed in 39 (22.7%) and 23 (13.4%) patients, respectively. Supratherapeutic, therapeutic, and subtherapeutic concentrations were observed in 74 (43.0%), 32 (18.6%), and 66 (38.4%), respectively. The patients with antidrug antibodies (n = 79, 45.9%) showed a higher frequency of having subtherapeutic drug concentrations (68.4% vs 12.9%, P &amp;lt; 0.001) compared to those without antibodies, and the presence of antibodies was an independent predictor of discontinuation of anti-TNFα agents (hazard ratio 3.50, 95% confidence interval 1.88-6.51, P &amp;lt; 0.001, Fig. 1A). In subgroup analysis, patients with antidrug antibodies and supratherapeutic drug concentration exhibited a tendency to have improved drug persistence compared to those with subtherapeutic drug concentration, albeit insignificantly (P = 0.099, Fig. 1B). However, the persistence in this group was still poorer than that observed in patients without antibodies (P = 0.003). Finally, neither anti-TNFα concentrations nor the presence of antidrug antibodies were associated with the need for additional systemic corticosteroid use within 6 months. Conclusion The presence of antidrug antibodies can predict the discontinuation of anti-TNFα agents despite supratherapeutic drug levels. While supratherapeutic drug concentration may improve the treatment persistence of anti-TNFα agents in patients with anti-drug antibodies, it does not last as long as in those without antibodies.

P703 Comparison of infliximab and adalimumab therapies Persistence in patients with Ulcerative Colitis: Results from a Single Tertiary Turkish IBD Center Cohort

Abstract Background In the last 25 years, the introduction of biological therapies has been a significant milestone in the management of inflammatory bowel diseases. Despite the recent emergence of new biological therapies and small molecules, Anti-TNF agents still play a crucial role in treatment. In a number of countries, anti-TNF agents are still reimbursed as a first line treatment following either a failure or intolerance to conventional therapies such as thiopurines and aminosalycilates. Many studies have been conducted previously to compare the efficacy of these drugs, but a clear conclusion could not be reached. In this study, we aimed to compare the persistence of infliximab (IFX) to adalimumab (ADA) in the treatment of ulcerative colitis at a tertiary IBD center in Turkey. Methods This was a retrospective cohort analysis of patients with ulcerative colitis either received adalimumab or infliximab as a first line biologic treatment. A total of 234 patients were included to this analysis. Demographic information such as gender, age, montreal classification, smoking and prior medications were noted from patients electronic medical records. Weighted Kaplan-Meier and Cox models were used to assess the outcomes. Results Out of the 234 patients included in the study, 116 had used infliximab, and 118 had used adalimumab as a first-line treatment. Age and gender of the patients in both groups did not differ from each other statistically. 88% of the patients treated with adalimumab and 84% of the patients treated with infliximab were thiopurine experienced. Montreal classification did not differ between two groups (in IFX group, 73% of the patients had Montreal E3 involvement where as in ADA group, 66% of the patients had Montreal E3 involvement, p&amp;gt;0.05). Primary non-response rates were not different between IFX and ADA group, 13.6% vs 13.4% respectively. In addition, clinical response rates after first year were 60% and 53% respectively. Drug persistency rates of adalimumab and infliximab in moderate to severe ulcerative colitis patients were not statistically different from each other (Figure 1). Conclusion Neither clinical efficacy rates nor drug persistency rates of adalimumab and infliximab in ulcerative colitis treatment were not different from each other. Factors such as age, gender, location of involvement, concomitant therapies, and smoking did not alter the outcome.

P870 Effectiveness and safety of adalimumab as first line biological treatment in Ulcerative Colitis

Abstract Background The increase in licensed therapies for ulcerative colitis (UC) is revolutionizing its treatment but making first line choice more challenging. Adalimumab (ADA) is inexpensive but, anecdotally, is sometimes regarded as less effective than other first line advanced therapies. We aimed to evaluate the results of first line ADA in UC. Methods We performed a single centre retrospective analysis of UC patients started on ADA between January 15 and March 2022 in an IBD referral hospital. Clinical remission was defined as SCCAI &amp;lt;2 points, endoscopic remission as a UCEIS &amp;lt;2 points and treatment failure as the need for colectomy or second biological line Results A total of 79 patients were included (Table 1). Median follow-up was 19 months (2-91); 78.5% were followed &amp;gt;6 months. At 6 months, 80.3% (61/76) and 37.3% (22/59) of the patients were in clinical and endoscopic remission, respectively. 54.3% received combination treatment with immunomodulators (50.6% thiopurines, 3.7% methotrexate). Dose intensification to weekly treatment occurred in 27.8% after median 9 months (4-48 months). During follow-up 51% received corticosteroids at some point (26% topically-acting oral corticosteroids, 10% oral corticosteroids, 15% both). Of patients who received steroids, 55% (22/40) were able to continue adalimumab therapy. 2.5% of patients were hospitalised for a disease flare. 5.1% had an infection recorded during follow up, none discontinued the treatment. No other major adverse events were recorded. In 22.8% (18/79) of patients, ADA was stopped due to treatment failure, mean 15 months after starting the drug (4-56 months), (Figure 1). None of these patients underwent colectomy at the time of stopping the drug; in 17/18 a second biological therapy was started (10 tofacitinib, 1 filgotinib, 1 upadacitinib, 2 ustekinumab, 2 vedolizumab, 1 golimumab). TDM was performed using a drug-sensitive ELISA, which is only able to detect antidrug antibodies when drug levels are low or absent. Drug levels at the time of stopping the drug were &amp;lt;5 µg/mL in 22% of patients (in 2 antibodies were detected), 5-8 µg/mL in 11% and &amp;gt;8 µg/mL in 67%. Conclusion In a real-world UC cohort, ADA appears to be an effective well tolerated first-line advanced therapy with the vast majority of patients reaching clinical remission and a significant proportion achieving mucosal healing. Table 1. Cohort characteristics (N 79, frequency and %). Figure 1: Kaplan-Meier survival analysis of time to ADA discontinuation.

P570 Efficacy and safety of Adalimumab in Very Early-onset IBD- A Multicentre Study from the Paediatric IBD Porto Group of ESPGHAN

Abstract Background Patients with very early onset inflammatory bowel disease (VEOIBD) often present with severe disease course and require escalation to biologics. Exclusion of pediatric patients from clinical trials lead to scarcity of efficacy and safety data on TNFa antagonists therapy in VEOIBD. We aimed to assess safety and efficacy of adalimumab (ADM) induction and maintenance therapy in patients with VEOIBD. Methods This was a retrospective study involving 31 sites affiliated with the IBD Porto Group and IBD Interest Group of ESPGHAN, as well as centers in North America. Demographic, clinical and laboratory data were collected from patients diagnosed with VEOIBD who commenced ADM therapy before 6 years of age between 2014 to 2023. Results We identified 77 VEOIBD patients with a median age at diagnosis of 2.6 years (interquartile range [IQR] 1.3–4.1), of whom 29 (38%) were diagnosed at age &amp;lt;2 years (infantile-onset IBD). Thirty-seven (48%) patients were diagnosed with Crohn’s disease, 25 (32%) with ulcerative colitis and 15 (20%) with IBD-unclassified. Five (9%) from those genetically tested were diagnosed with monogenic disease. Median age at initiation of ADM was 4.2 (IQR 2.8-5.1) years. Forty-four patients (57%) were Infliximab experienced, discontinued mainly due to pharmacokinetic (20 [45%]) and pharmacodynamic (13 [30%]) failures. At initiation of ADM, concomitant corticosteroids and immunomodulators were given in 37 (48%) and 29 (37%) patients, respectively. The median wPCDAI and PUCAI scores at baseline were 45 [37.5-60] and 45 [27.5-57.5], respectively. Median follow-up time was 85.4 (IQR 40.4-139.2) weeks. While patients with CD showed significant clinical improvement after 26 and 52 weeks (PCDAI decreased to 10 [0-33.4], p&amp;lt;0.001, and 10 [0-25], p&amp;lt;0.05, respectively), No significant improvement in PUCAI score was observed among patients with UC (Figure 1). Inflammatory markers and calprotectin showed a gradual decrease over time (Figure 1). Weight and Height Z scores did not differ significantly throughout the follow-up period. ADM discontinuation rates after 1 and 3 years were 40% and 65%, respectively, mainly due to primary non-response (14, 29.8%) and loss of response (19, 40.4%). Drug discontinuation rates were not dependent on concomitant immunomodulator treatment or ADM initiation or on age (less or above 3 years). Four patients (5.2%) developed severe infections, including a patient with TTC7A mutation who died following septic shock. Conclusion Adalimumab therapy was relatively safe and seemed more effective in young patients with Crohn’s disease, but not in those with ulcerative colitis. Durability was relatively low due to high rates of primary non-response and secondary loss of response.

A case report on new-onset peritoneal tuberculosis in ankylosing spondylitis patient on adalimumab

Adalimumab, a widely employed tumor necrosis factor-alpha inhibitor for autoimmune diseases, raises concern about reactivating latent tuberculosis (TB) and new-onset TB. Despite its established efficacy in managing inflammation, clinicians must recognize and manage adalimumab-induced TB promptly to minimize associated morbidity. This case report explores guidelines for TB screening in adalimumab-treated patients, utilizing interferon-gamma release assays and tuberculin skin tests, and discusses treatment considerations. Increased TB incidence in adalimumab-treated patients necessitates vigilant screening for latent TB before therapy initiation. Therapeutic decisions must balance the need for continuing immunosuppressive therapy against the potential risks of uncontrolled TB. Diagnostic challenges arise from atypical presentations and the intricate interplay between adalimumab therapy and TB manifestations. Given adalimumab’s expanding use, clinicians should be mindful of potential TB reactivation, emphasizing thorough screening, diagnosis, and management for improved patient care and safety amidst immunosuppressive therapies. Here, we are presenting the case of adalimumab-induced peritoneal TB.

Baseline ANA and Anti‐Ro60/SSA Antibody as Potential Predictors for Immunogenicity and Poor EULAR Response in Adalimumab‐Treated RA Patients

What Is Known and Objective. Given that autoantibodies are relatively abundant and easily measured, the detection of antibody biomarkers would be ideal for predicting therapeutic responses. Although anti‐Ro60/SSA (anti‐TROVE2) antibody has been identified as a useful predictor for the development of immunogenicity and therapeutic failure to adalimumab in RA patients, autoantibodies with similar predictive potentials are not yet sufficiently validated. Methods. We aimed to investigate the baseline autoantibodies, including rheumatoid factor (RF)‐IgM, anti‐citrullinated peptide antibodies (ACPA), antinuclear antibody (ANA), anti‐Ro60/SSA antibody, and anti‐La/SSB antibody, for their relationships with drug immunogenicity and therapeutic responses in RA patients assessed at week 48 of adalimumab therapy. We also compared adalimumab drug survival between participants with or without these autoantibodies. Results and Discussion. Our results showed that poor EULAR responders had significantly higher positive rates of baseline ANA, anti‐Ro60/SSA antibody, and anti‐La/SSB antibody than moderate or good responders. However, no significant differences in circulating levels of RF‐IgM or ACPA were observed among groups with different responses. The multivariate logistic regression analysis revealed that ANA and anti‐Ro60/SSA antibodies were significant predictors of developing immunogenicity to adalimumab (both p &lt; 0.001). The presence of ANA, anti‐Ro60/SSA, and anti‐SSB antibodies could significantly predict poor EULAR response in adalimumab‐treated RA patients (odds ratio, 4.98, 5.60, and 8.08, respectively, all p &lt; 0.01). In Kaplan–Meier analysis, the adalimumab drug survival rate was significantly lower in RA patients with positivity for ANA, anti‐Ro60/SSA, anti‐SSB, and anti‐drug antibodies than in the seronegative group. What Is New and Conclusion. Our results suggest that baseline ANA and anti‐Ro60/SSA antibodies are potential predictive markers of drug immunogenicity and poor EULAR response in adalimumab‐treated RA patients.

Prediction of Clinical Remission with Adalimumab Therapy in Patients with Ulcerative Colitis by Fourier Transform-Infrared Spectroscopy Coupled with Machine Learning Algorithms.

We aimed to develop prediction models for clinical remission associated with adalimumab treatment in patients with ulcerative colitis (UC) using Fourier transform-infrared (FT-IR) spectroscopy coupled with machine learning (ML) algorithms. This prospective, observational, multicenter study enrolled 62 UC patients and 30 healthy controls. The patients were treated with adalimumab for 56 weeks, and clinical remission was evaluated using the Mayo score. Baseline fecal samples were collected and analyzed using FT-IR spectroscopy. Various data preprocessing methods were applied, and prediction models were established by 10-fold cross-validation using various ML methods. Orthogonal partial least squares-discriminant analysis (OPLS-DA) showed a clear separation of healthy controls and UC patients, applying area normalization and Pareto scaling. OPLS-DA models predicting short- and long-term remission (8 and 56 weeks) yielded area-under-the-curve values of 0.76 and 0.75, respectively. Logistic regression and a nonlinear support vector machine were selected as the best prediction models for short- and long-term remission, respectively (accuracy of 0.99). In external validation, prediction models for short-term (logistic regression) and long-term (decision tree) remission performed well, with accuracy values of 0.73 and 0.82, respectively. This was the first study to develop prediction models for clinical remission associated with adalimumab treatment in UC patients by fecal analysis using FT-IR spectroscopy coupled with ML algorithms. Logistic regression, nonlinear support vector machines, and decision tree were suggested as the optimal prediction models for remission, and these were noninvasive, simple, inexpensive, and fast analyses that could be applied to personalized treatments.

Improved clinical effectiveness of adalimumab when initiated with clindamycin and rifampicin in hidradenitis suppurativa.

Adalimumab monotherapy for hidradenitis suppurativa (HS) is often insufficient with a maximum clinical efficacy of 60% in Hidradenitis Suppurativa Clinical Response (HiSCR) and limited effect on draining tunnels. Data suggest that adalimumab therapy could be improved by concomitant antibiotics. To compare the clinical effectiveness of adalimumab with clindamycin and rifampicin versus adalimumab monotherapy after 12 weeks. This retrospective study included patients who started adalimumab with additional clindamycin and rifampicin and patients treated with adalimumab monotherapy, matched on sex and refined Hurley score. The primary outcome measure was the difference in change in the International Hidradenitis Suppurativa Severity Score System (IHS4) at 12 weeks. In total, 62 patients were included in the combination therapy group (n = 31) and adalimumab monotherapy group (n = 31), showing comparable IHS4 scores; 32.5 versus 29, p = 0.87 at baseline respectively. The combination therapy demonstrated greater clinical effectiveness expressed in median IHS4 improvement (-20 vs. -9, p < 0.001), IHS4-55 (74% vs. 36%, p = 0.002), median draining tunnel reduction (-4 vs. -2, p < 0.001) and pain response (47% vs. 27%, p = 0.02). Adalimumab initiated with clindamycin and rifampicin shows greater clinical effectiveness than adalimumab monotherapy. An important difference in effect was observed in the decrease of draining tunnels, addressing a serious limitation of adalimumab monotherapy.

Efficacy and Safety of Adalimumab Biosimilar GP2017 in Patients with Inflammatory Bowel Disease.

(1) Background: GP2017 is one of the biosimilar drugs of adalimumab, one of the anti-TNF agents used for inflammatory bowel disease (IBD). To date, there is little real-world data about the use of GP2017 in IBD patients. The aim of our study was to evaluate the effectiveness and safety of this biosimilar in an IBD population. (2) Methods: This is an observational retrospective study including patients that were all treated with GP2017 as a first step or as a switch from the originator or other biosimilars. The clinical activity was evaluated at baseline and after 6 and 12 months of therapy. The therapy discontinuation and side effects were also evaluated. (3) Results: a total of 72 patients were included (65 with Crohn's disease and 7 with ulcerative colitis). Of the 29 patients starting GP2017 as a first adalimumab therapy, clinical remission was achieved in 58.6%. Of the patients starting GP2017 as a switch from the originator (33 patients) or other biosimilars (10 patients), clinical remission was maintained in 78.8% and in 70%, respectively. Regarding the safety, only 11 patients experienced non-serious side effects. During the follow-up, nine patients suspended treatment mainly due to side effects or secondary failure. (4) Conclusions: GP2017 is an effective and safe therapy for IBD patients.

Efficacy, retention rate and safety of adalimumab treatment in patients with non-infectious uveitis and scleritis: a real-world, retrospective, single-centre study.

To evaluate the outcomes of adalimumab (ADA) treatment of patients with non-infectious uveitis and scleritis, focusing on efficacy, retention rate, and safety. This retrospective, clinical cohort study included 62 patients (104 eyes) with active ocular inflammation treated with ADA. Primary outcomes were efficacy and cumulative drug retention rate (DRR) of ADA. The secondary outcomes included changes in ocular inflammatory parameters, changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT), corticosteroid-sparing effect, impact of concomitant use of disease-modifying antirheumatic drug (DMARD) and ADA as first or ≥2nd biotherapy line on DRR, and adverse events. Forty-five patients (72.6%) achieved inactive disease at the end of follow-up. DRR at 6, 12, 24, and 48 months was 96.8%, 89.2%, 63.1%, and 63.1%, respectively. Of the 18 patients whose bi-weekly ADA treatment was escalated to weekly ADA due to primary or secondary inefficacy, 10 patients had inactive disease finally. BCVA improved (p < 0.001) and CMT decreased (p < 0.001) significantly at 6, 12, and 24 months after ADA therapy compared to baseline. Percentage of patients treated with ≥10 mg/day corticosteroid (61.3% vs. 6.4%) and DMARDs combined with ADA (46.8% vs. 37.1%) were lower at 6 months than at baseline. Concomitant DMARDs (p = 0.579) and use of ADA as first or ≥2nd biotherapy line (p = 0.527) had no significant effect on DRR. Most common adverse event was tuberculosis-related infections. ADA seems to be effective and safe with good DRR to control ocular inflammation. Escalation to weekly ADA treatment may be an effective option in patients with primary or secondary inefficacy.

Efficacy of Switching to Adalimumab for Maintenance of Remission Following Induction Therapy with Tacrolimus in Patients with Ulcerative Colitis.

Tacrolimus (TAC) effectively induces remission in refractory ulcerative colitis (UC). However, TAC therapy usually lasts for 3 months. Although azathioprine (AZA) is often used in maintenance therapy, the relapse rate remains high. Herein, we evaluated the efficacy of adalimumab (ADA) for remission maintenance in patients with UC after induction therapy with TAC. We prospectively enrolled patients with moderate-to-severe UC who achieved clinical remission after 3 months of TAC therapy with endoscopic non-mucosal healing (Cohort A). After TAC discontinuation, the remission maintenance rate up to 1 year after starting ADA therapy was examined. We retrospectively enrolled patients with UC treated with TAC (Cohort B). Among patients in clinical remission after TAC treatment for 3 months, those who received AZA as remission maintenance therapy after TAC discontinuation constituted the AZA group. Patients in Cohort A who received ADA and AZA as remission maintenance therapy after TAC discontinuation constituted the ADA + AZA group. We compared the remission maintenance rates in the AZA and ADA + AZA groups for up to 5 years after TAC discontinuation. In Cohort A, of the 46 patients with UC treated with TAC, 17 were eligible for analysis after receiving ADA as remission maintenance therapy. A notable 88.2% (15/17) were still in remission 1 year after starting ADA. The ADA + AZA group (n = 16) exhibited a significantly higher relapse-free rate than the AZA group (n = 26) (p < 0.05; log-rank test). switching to ADA for remission maintenance in patients with refractory UC who achieved clinical remission with TAC is clinically useful.

Ocular toxoplasmosis following anti-tumour necrosis factor-α therapy combined with oral methotrexate therapy: A case report and review of literature.

Purpose: To report a case of ocular toxoplasmosis following long-term treatment with adalimumab and review the literature on ocular toxoplasmosis following anti-Tumour necrosis factor-α therapy. Method: A retrospective chart review of A 21-year-old male who developed retinochoroiditis in his left eye following adalimumab therapy combined with oral methotrexate. Result: A known patient of juvenile idiopathic arthritis (JIA) on adalimumab and oral methotrexate for the last four years presented to us with a blurring of vision for the last 15 days. Fundus examination of the left eye revealed severe vitritis and two patches of retinochoroiditis in the inferior part of the fundus. Subsequent investigations confirmed it to be a case of toxoplasma retinochoroiditis, and he responded to anti-toxoplasma treatment. A review of literature on a similar topic revealed five such cases, and the index case was the first such report in patients with JIA. Conclusion: The index case highlights the importance of early recognition and management of opportunistic infections in patients receiving biologicals.

S3222 Rash and Remedy: Leukocytoclastic Vasculitis Associated With Adalimumab Therapy in Crohn's Disease

S3222 Rash and Remedy: Leukocytoclastic Vasculitis Associated With Adalimumab Therapy in Crohn's Disease

Paediatric acrodermatitis continua of Hallopeau: perspectives of a patient and their mother.

Rare dermatological conditions can present profound and unique challenges to paediatric patients and their families. This spans from the challenge of referral to appropriate services to understanding of peers, educators and extended family members. We explore the perspectives of a mother and a patient on the difficulty faced navigating a case of acrodermatitis continua of Hallopeau, from their years managing the condition themselves to the rapid response the patient had to fortnightly adalimumab therapy and the positive impact on their lives.

The Humira in Ocular Inflammations Taper (HOT) Study

To assess factors that impact the risk of relapse in patients with noninfectious uveitis (NIU) who undergo adalimumab tapering after achieving remission. Retrospective study. In this multicenter study, patients with NIU were treated with adalimumab and subsequently tapered. Patient demographics, type of NIU, onset and duration of disease, the period of inactivity before tapering adalimumab, and the tapering schedule were collected. The primary outcome measures were independent predictors of the rate of uveitis recurrence after adalimumab tapering. Three hundred twenty-eight patients were included (54.6% female) with a mean age of 34.3 years. The mean time between disease onset and initiation of adalimumab therapy was 35.2 ± 70.1 weeks. Adalimumab tapering was commenced after a mean of 100.8 ± 69.7 weeks of inactivity. Recurrence was observed in 39.6% of patients at a mean of 44.7 ± 61.7 weeks. Patients who experienced recurrence were significantly younger than those without recurrence (mean 29.4 years vs 37.5 years, P=.0005), and the rate of recurrence was significantly higher in younger subjects (hazard ratio [HR]=0.88 per decade of increasing age, P=.01). The lowest rate of recurrence was among Asian subjects. A faster adalimumab taper was associated with an increased recurrence rate (HR=1.23 per unit increase in speed, P < .0005). Conversely, a more extended period of remission before tapering was associated with a lower rate of recurrence (HR=0.97 per 10-weeks longer period of inactivity, P=.04). When tapering adalimumab, factors that should be considered include patient age, race, and duration of disease remission on adalimumab. A slow tapering schedule is advisable.

Clinical Response to Tumor Necrosis Factor-α Inhibitor Therapy in the Management of Cardiac Sarcoidosis

Evidence that tumor necrosis factor-α (TNF-α) inhibitors may benefit patients with cardiac sarcoidosis (CS) is limited to small case series and both imaging and clinical outcomes in this population are not well known. This study aimed to evaluate the disease course of patients with CS treated with either infliximab or adalimumab therapy based on serial 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) imaging and clinical outcomes. An institutional CS research database was queried for patients treated with TNF-α inhibitors between 2016 and 2021. Outcomes included (1) change in mean prednisone dose, (2) FDG-PET improvement, and (3) unplanned hospitalizations, advanced heart failure therapies, or death. Our query yielded 31 patients with CS. A total of 13 patients were on infliximab, 15 patients were on adalimumab, and 3 patients were on adalimumab before transitioning to infliximab. Mean prednisone dose decreased between FDG-PET immediately preceding TNF-α and second after TNF-α FDG-PET (18.6±15.7mg to 7.7±12.4mg, p=0.018). A significant decrease was seen in the mean number of segments demonstrating FDG uptake between most recent pre-TNF-α and first after TNF-α inhibitor FDG-PET (mean segments=4.2 vs 3.1, p=0.048). Between earliest pre-TNF-α and first after TNF-α FDG-PET there was a numerical decrease in average myocardial maximum standard uptake values (SUVmax) (4.4 vs 3.1, p=0.18), and the ratio of SUVmax myocardium:SUVmax blood pool (1.9 vs 1.5, p=0.26). Within 36months of initiating TNF-α inhibitor, 4 patients (13%) experienced unplanned cardiovascular hospitalization (median time to hospitalization=12.1months). In conclusion, in patients with CS, TNF-α inhibitor therapy is associated with decreased glucocorticoid use, numerical decrease in cardiac FDG uptake, and minimal cardiac morbidity.

Peristomal Hidradenitis Suppurativa: A Case and Review of the Literature

Hidradenitis suppurativa (HS) is a chronic, inflammatory condition of apocrine gland-bearing skin that typically presents as deep, inflamed lesions in the axillary, inguinal, perineal, and mammary regions. We present a rare case of a man in his 60s with a history of HS who presented with a peristomal sinus tract, as well as non-healing, draining wounds around his stoma site that responded well to adalimumab therapy. A compounded clobetasol ointment with poly(ethelyene oxide) polymers (POLYOXTM, Dupoont) was utilized to maintain stoma appliance adhesion, and his lesions effectively cleared with adalimumab.