Safety Of Adalimumab In Patients Research Articles

Effectiveness and safety of adalimumab in patients with intestinal Behçet’s disease: a real-world prospective observational study in South Korea

BackgroundIntestinal Behçet’s disease (BD) is characterized by typical gastrointestinal ulcers in patients with BD followed by complications such as bleeding, perforation and fistula. Biologic agents are currently under active investigation to delay the disease course. Various data regarding infliximab are available, but there is relatively lack of data regarding adalimumab.MethodsThis was a multicenter, real-world prospective observational study to evaluate the effectiveness and safety of adalimumab in intestinal BD. The primary endpoint was disease activity at each follow up, including disease activity index for intestinal Behçet’s disease (DAIBD), serum C-reactive protein (CRP) level, and endoscopic findings. The secondary endpoint was the incidence of adverse drug reactions (ADRs).ResultsA total of 58 patients were enrolled and 8 of them were excluded. Adverse events were reported in 72.0% of patients with 122 events. ADRs were reported in 24.0% with 28 events. For adverse events, arthralgia was most commonly reported (13.1%: 16/122) and only one experienced critical adverse event (0.82%, 1/122: death due to stroke). On multivariable regression analysis, a longer disease duration was significantly associated with decreased ADRs [Odds ratio 0.976 (0.953–0.999, 95% CI); p = 0.042]. Clinical response rates as assessed by DAIBD were 90.9% at Week 12 and 89.7% at Week 56, respectively. The mean serum CRP level at baseline was significantly decreased after 12 weeks (3.91 ± 4.93 to 1.26 ± 2.03 mg/dL; p = 0.0002).ConclusionAdalimumab was found to be safe and effective in Korean patients with intestinal BD. A longer disease duration was significantly associated with decreased ADRs.

Efficacy and Safety of Adalimumab in Patients with Behçet Uveitis: A Systematic Review and Meta-Analysis

ABSTRACT Purpose To examine the long-term efficacy and safety of adalimumab (ADA) in patients with Behçet uveitis (BU). Methods A systematic review and meta-analysis of observational studies was performed. Pooled results are presented as mean difference or standardized mean difference (std diff) and 95% confidence intervals (CI). Visual acuity (VA), intraocular inflammation grade, central macular thickness, corticosteroid (CS) sparing effect and adverse events were evaluated. Results Ten studies were included finally for quantitative and qualitative synthesis. ADA therapy resulted in 0.124 (95%CI: 0.084, 0.165) logMAR improvement in VA. In addition, ADA therapy resulted in decreased grade of intraocular inflammation [std diff, −1.187 (95%CI: -1.508, -0.866)] and macular thickness [std diff, −0.564 (95%CI: -0.843, -0.286)] and caused a decrease in CS dosage [std diff, −1.809 (95%CI: -2.420, -1.198)]. The pooled rate of overall adverse events for ADA in 301 patients was 8.5% (95%CI: 0.039, 0.177). Conclusion ADA is an efficient therapy that improves VA and controls intraocular inflammation, macular edema and retinal vasculitis. As the disease exposure time increased, improvement in VA was less. The safety and CS-sparing effect of ADA were demonstrated with few adverse effects. The results provided evidence that ADA can be used safely and efficiently as the first-line drug in patients with BU.

Efficacy and safety of adalimumab in patients with Crohn's disease

Objective: To assess the effectiveness and safety of adalimumab in Crohn's disease (CD) patients. Methods: We retrospectively reviewed the charts of 41 CD patients who received adalimumab in Zhongda Hospital Southeast University from January 2020 to August 2021. General clinical data, laboratory results, endoscopy and radiologic findings were collected, meanwhile, disease activity and safety events were evaluated at baseline and at 12, 24 and 48 weeks of administration. Adalimumab was given subcutaneously once every 2 weeks in doses of 160 mg for the first time, 80 mg for the second time, and 40 mg for each subsequent time. Results: The clinical remission rates at 12, 24, and 48 weeks of treatment were 43.9% (18/41), 60.6% (20/33), 60.9% (14/23), and the clinical response rates were 75.6% (31/41), 69.7% (23/33), and 56.5%( 13/23), respectively. The proportion of endoscopic remission at 12, 24 and 48 weeks were 4/14, 2/6, 1/4 in patients undergoing endoscopy, and 1/14 patients achieved mucosal healing at 24 weeks. Primary nonresponse rate (PNR) was 17.1% (7/41), loss of response (LOR) rate was 14.6% (6/41). The incidence of adverse reactions was 9.8%(4/41). Conclusion: Adalimumab can effectively relieve the clinical symptoms and intestinal disease activities of Crohn's disease, and deserves to be popularized clinically. Patients with disease course <2 years, first-line biologics, low baseline HBI score, and longer duration of medication may have better results.

Efficacy and safety of adalimumab in hidradenitis suppurativa: A systematic review and meta-analysis of randomized controlled trials.

Background:Adalimumab is used as a first-line biologic agent in the management of moderate-to-severe hidradenitis suppurativa (HS). The objective of the present study was to evaluate the efficacy and safety of adalimumab in patients with moderate-to-severe HS.Methods:We performed a systematic review and meta-analysis according to Preferred Reporting Items for Systematic reviews and Meta-Analysis guidelines. Pooled estimates, namely standardized mean difference (SMD) and relative risk (RR), were calculated using random-effect model with trial sequential analysis. Small study effects were examined using the Doi plot. Certainty of evidence (CoE) was assessed using “The Grading of Recommendations Assessment, Development, and Evaluation” approach, and number-needed-to-treat (NNT) was calculated.Results:Five randomized controlled trials, involving 1014 patients, were included. We performed subgroup analysis of adalimumab administered subcutaneously both weekly and every other week. Adalimumab administered weekly was associated with better clinical response achievement (RR 1.76, 95% confidence interval [95% CI] 1.35–2.29; trial sequential analysis TSA-adjusted CI 1.01–3.08; CoE: low; NNT = 5) and a significant improvement in modified Sartorius score (SMD = −0.45, 95% CI = −0.76 to −0.13; CoE: very low; NNT = 10) and dermatology life quality index (DLQI) (SMD −0.47, 95% CI −0.61 to −0.32; CoE: low; NNT = 10). Nevertheless, adalimumab administered every other week showed an improvement only in modified Sartorius score. The pooled RRs of adverse events in both groups revealed no statistical significance when compared with the placebo.Conclusions:Adalimumab administered weekly resulted in not only better clinical responses than placebo but also significantly improved disease severity and quality of life of patients with moderate-to-severe HS. Our study provides supporting evidence to the current guidelines and aids decision-making in the application of adalimumab in HS management.

Long-term safety of adalimumab for patients with moderate-to-severe hidradenitis suppurativa

ABSTRACTIntroduction: Hidradenitis suppurativa (HS) is a chronic debilitating inflammatory skin disorder that affects regions rich in apocrine glands. Although the etiology of HS is not clear, inflammatory cytokines, like tumor necrosis factor (TNF)-α, participate in pathogenesis. Adalimumab (ADA), a human IgG1 monoclonal antibody that selectively targets TNFα, is the only EMA/FDA-approved biologic agent available for the therapy of moderate-to-severe HS.Areas covered: A comprehensive literature search was conducted to present existing studies with an emphasis on the safety profile of ADA for the treatment of moderate-to-severe HS. ADA is prescribed for more than 15 years for varied indications and has improved the therapeutic outcomes of many diseases. Clinical trials and real-life safety data from ADA administration in HS were presented, with particular attention to special populations, such as children, elderly, and pregnant women.Expert opinion: Existing data advise for limited safety concerns with long-term ADA treatment provided that patients are thoroughly screened for infections, latent tuberculosis, and history of malignancy before the start of treatment.

P494 The efficacy and safety of adalimumab for patients with moderately to severely active ulcerative colitis and predictors of response in Korea

Abstract Background The aim of this study to assess the efficacy and safety of adalimumab (ADA), a monoclonal antibody against tumour necrosis factor α (TNF-α), and to explore predictors of response in Korean patients with ulcerative colitis (UC). Methods We conducted a prospective observational multicenter study over 56 weeks in adult patients with moderately to severely active UC. Clinical response and remission were assessed by Mayo score. Mucosal healing was defined as Mayo subscore 0 or 1. Faecal calprotectin (FC) were assessed at baseline, week 8 and 56. Adalimumab drug levels were checked at week 8 and at loss of response. Missing or incomplete data were handled using the nonresponder imputation method. Results A total of 146 patients were enrolled and included in the analysis. Clinical response rates were 52.1% (76/146) and 37.7% (55/146) at week 8 and 56, respectively. Clinical remission was achieved in 24.0% (35/146) and 21.9% (32/146) of patients at week 8 and 56. Steroid-free remission rates were 21.2% (31/146) at week 56. Mucosal healing rates were 39.0% (57/146) and 30.1% (44/146) at week 8 and 56. Prior use of anti-TNF-α did not affect the clinical and endoscopic responses. Treatment persistence was achieved in 57.5% (84/146) of patients at week 56. Adalimumab drug level was significantly higher in patients with clinical response (10.8 vs. 8.0, p = 0.004), clinical remission (11.7 vs. 8.8, p = 0.007) and mucosal healing (11.0 vs. 8.5, p = 0.010) at week 8. Adalimumab dose was escalated to 40 mg weekly in 25 (17.1%) patients, and clinical response and remission were achieved in 40% and 20% of patients at week 56, respectively. Mean faecal calprotectin levels were significantly more decreased in clinical responders compared with non-responders at week 8 (336.3 mg/kg vs. 628.8 mg/kg, p &amp;lt; 0.001). The Fecal calprotectin levels are well correlated with endoscopic severity, and the best cut-off value to predict mucosal healing was 274 mg/kg. The lower endoscopic severity, higher body mass index and higher serum albumin level at baseline were associated with a clinical response at week 8. The lower Mayo score, lower C-reactive protein level, clinical response (74.5% vs. 38.5%, p &amp;lt; 0.001) and mucosal healing (52.7% vs. 30.8%, p = 0.008) at week 8 were associated with clinical response at week 56. Serious adverse drug reactions were identified in 2.7% (4/146) of patients including 1 case of pulmonary tuberculosis. Conclusion Adalimumab is safe and effective for induction and maintenance in Korean patients with UC, regardless of prior anti-TNF therapy. Adalimumab drug level is associated with the efficacy of induction therapy. A better response to induction therapy can predict a better long-term response.

Assessment of Long-Term Efficacy and Safety of Adalimumab in Patients with Ulcerative Colitis: Results from a 6-Year Real-World Clinical Practice

Background: Although evidence for the short- to medium-term efficacy of adalimumab in ulcerative colitis (UC) patients is emerging, there are a limited number of reports on the long-term efficacy of adalimumab. This study was to understand baseline demographic features, which potentially could be risk factors for relapse or colectomy following induction of remission by adalimumab in UC patients. Additionally, factors affecting long-term outcomes were to be identified. Methods: Twenty-one patients with UC who had been treated with adalimumab were reviewed retrospectively. Comparative analyses were undertaken by factoring steroid withdrawal versus non-withdrawal, long-term remission versus relapse following remission, and requiring surgical intervention for UC versus surgery-free. Results: Adalimumab treatment was associated with steroid tapering in steroid-dependent cases in the long term. Of the 14 patients in whom clinical remission was achieved, the cumulative nonrelapse survival rate at 350 weeks was 43.8% and the cumulative nonoperative survival rate was 85.7%. Risk factors for surgery included intolerance to salicylates (p = 0.005) and past treatment with tacrolimus (p = 0.023). Conclusions: Adalimumab treatment was associated with long-term efficacy in patients with mild UC – patients achieved a high cumulative nonoperative survival rate over a long period of time, beyond 6 years.

Safety of adalimumab in patients with Crohn's disease

Safety of adalimumab in patients with Crohn's disease

Mo1861 - Long-Term Safety of Adalimumab in Patients with Moderate to Severe Ulcerative Colitis: Interim Results of a Noninterventional Registry, Legacy

Mo1861 - Long-Term Safety of Adalimumab in Patients with Moderate to Severe Ulcerative Colitis: Interim Results of a Noninterventional Registry, Legacy

DOP004 Long-term safety of adalimumab in patients with moderate-to-severe ulcerative colitis: Interim results of a non-interventional registry, LEGACY

DOP004 Long-term safety of adalimumab in patients with moderate-to-severe ulcerative colitis: Interim results of a non-interventional registry, LEGACY

Long-Term Effectiveness of Adalimumab in Patients with Rheumatoid Arthritis: An Observational Analysis from the Corrona Rheumatoid Arthritis Registry.

IntroductionCurrent recommendations for the management of rheumatoid arthritis (RA) focus on a treat-to-target approach with the objective of maximizing long-term health-related quality-of-life in patients with RA. Published studies from randomized clinical trials have reported limited data regarding the long-term efficacy and safety of adalimumab in patients with RA. This study aims to evaluate the long-term (10+ years) persistency and effectiveness of adalimumab in patients with RA in a real-world setting.MethodsIncluded in this study were biologic-naïve adults with RA initiating adalimumab during follow-up enrolled in the Corrona RA registry. More than 10 years of data on persistency of adalimumab and rheumatologist-supplied reasons for discontinuation were examined. Among patients who persisted on adalimumab over the years, clinical [e.g., clinical disease activity index scores (CDAI), physician global assessment, tender joint count, and swollen joint count] and patient-reported outcomes (PRO), such as physical function, pain, fatigue, and morning stiffness, were examined.ResultsOf 1791 biologic-naive patients treated with adalimumab who had ≥1 follow-up registry visit, 64.1% were still on therapy at 1 year and 10.2% were still on therapy by the end of year 12. Among patients who persisted on adalimumab for at least 1 year (77.1% female, mean age 53.9 years), 67.0% were in low disease activity (LDA)/remission (CDAI ≤10) and had clinically meaningful improvements from baseline in all clinical assessments and PROs. Initial improvements in LDA/remission and in clinical and PRO assessments observed at year 1 were sustained in those patients who remained on adalimumab over 10 years of follow-up. Among patients who discontinued adalimumab, 61.6% were not in LDA/remission and 41.9% switched to another biologic within 12 months after discontinuing adalimumab.ConclusionsReal-world data demonstrate a sustained effectiveness of adalimumab in the treatment of RA for patients who remained on therapy for 10 years.FundingCorrona, LLC and AbbVie.

616 - Long-Term Safety of Adalimumab in Patients with Crohn's Disease: Final Data from Pyramid Registry

616 - Long-Term Safety of Adalimumab in Patients with Crohn's Disease: Final Data from Pyramid Registry

P353 Long-term safety of adalimumab in patients with Crohn's disease: final data from PYRAMID registry

P353 Long-term safety of adalimumab in patients with Crohn's disease: final data from PYRAMID registry

Long-term Efficacy and Safety of Adalimumab in Pediatric Patients with Crohn's Disease.

IMAgINE 1 assessed 52-week efficacy and safety of adalimumab in children with moderate to severe Crohn's disease. Long-term efficacy and safety of adalimumab for patients who entered the IMAgINE 2 extension are reported. Patients who completed IMAgINE 1 could enroll in IMAgINE 2. Endpoints assessed from weeks 0 to 240 of IMAgINE 2 were Pediatric Crohn's Disease Activity Index remission (Pediatric Crohn's Disease Activity Index ≤ 10) and response (Pediatric Crohn's Disease Activity Index decrease ≥15 from IMAgINE 1 baseline) using observed analysis and hybrid nonresponder imputation (hNRI). For hNRI, discontinued patients were imputed as failures unless they transitioned to commercial adalimumab (with study site closure) or adult care, where last observation was carried forward. Corticosteroid-free remission in patients receiving corticosteroids at IMAgINE 1 baseline, discontinuation of immunomodulators (IMMs) in patients receiving IMMs at IMAgINE 2 baseline, and linear growth improvement were reported as observed. Adverse events were assessed for patients receiving ≥1 adalimumab dose in IMAgINE 1 and 2 through January 2015. Of 100 patients enrolled in IMAgINE 2, 41% and 48% achieved remission and response (hNRI) at IMAgINE 2 week 240. Remission rates were maintained by 45% (30/67, hNRI) of patients who entered IMAgINE 2 in remission. At IMAgINE 2 week 240, 63% (12/19) of patients receiving corticosteroids at IMAgINE 1 baseline achieved corticosteroid-free remission and 30% (6/20) of patients receiving IMMs at IMAgINE 2 baseline discontinued IMMs. Adalimumab treatment led to growth velocity normalization. No new safety signals were identified. Efficacy and safety profiles of prolonged adalimumab treatment in children with Crohn's disease were consistent with IMAgINE 1 and adult Crohn's disease adalimumab trials.

Adalimumab Treatment in Patients with Vogt–Koyanagi–Harada Disease

ABSTRACTPurpose: To evaluate the clinical outcome and safety of adalimumab in patients with Vogt–Koyanagi–Harada (VKH) disease.Methods: VKH patients treated with adalimumab seen at the University of Buenos Aires were reviewed. Main outcome measures were visual acuity, anterior segment inflammation, optic nerve inflammation (ONI), steroid sparing effect, number of immunosuppressives, and relapses.Results: In total, 14 VKH patients, mean age 23.07 ± 8 years; median of adalimumab treatment 10 months, were analyzed. At start of adalimumab treatment (baseline), median of corticosteroid dose was 20 mg and at 6 months, 4 mg. At baseline, 11 patients were on immunosuppressive treatment and at 6 months only four continued with immunosuppressive therapy. In the 28 eyes, the median of active inflammation was 2 at baseline and 0 after 6 months on adalimumab.Conclusions: Treatment with adalimumab is an effective and safe option, reducing the need for oral corticosteroid and conventional immunosuppressive therapy.

Adalimumab for prevention of uveitic flare in patients with inactive non-infectious uveitis controlled by corticosteroids (VISUAL II): a multicentre, double-masked, randomised, placebo-controlled phase 3 trial

Non-infectious uveitis is a potentially sight-threatening ocular disorder caused by chronic inflammation and its complications. Therapeutic success is limited by systemic adverse effects associated with long-term corticosteroid and immunomodulator use if topical medication is not sufficient to control the inflammation. We aimed to assess the efficacy and safety of adalimumab in patients with inactive, non-infectious uveitis controlled by systemic corticosteroids. We did this multicentre, double-masked, randomised, placebo-controlled phase 3 trial at 62 study sites in 21 countries in the USA, Canada, Europe, Israel, Australia, and Latin America. Patients (aged ≥18 years) with inactive, non-infectious intermediate, posterior, or panuveitic uveitis controlled by 10-35 mg/day of prednisone were randomly assigned (1:1), via an interactive voice and web response system with a block size of four, to receive either subcutaneous adalimumab (loading dose 80 mg; biweekly dose 40 mg) or placebo, with a mandatory prednisone taper from week 2. Randomisation was stratified by baseline immunosuppressant treatment. Sponsor personnel with direct oversight of the conduct and management of the study, investigators, study site personnel, and patients were masked to treatment allocation. The primary efficacy endpoint was time to treatment failure, a multicomponent endpoint encompassing new active inflammatory chorioretinal or inflammatory retinal vascular lesions, anterior chamber cell grade, vitreous haze grade, and visual acuity. Analysis was done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov number NCT01124838. Between Aug 10, 2010, and May 14, 2015, we randomly assigned 229 patients to receive placebo (n=114) or adalimumab (n=115); 226 patients comprised the intention-to-treat population. Median follow-up time was 155 days (IQR 77-357) in the placebo group and 245 days (119-564) in the adalimumab group. Treatment failure occurred in 61 (55%) of 111 patients in the placebo group compared with 45 (39%) of 115 patients in the adalimumab group. Time to treatment failure was significantly improved in the adalimumab group compared with the placebo group (median not estimated [>18 months] vs 8·3 months; hazard ratio 0·57, 95% CI 0·39-0·84; p=0·004). The 40th percentile for time to treatment failure was 4·8 months in the placebo group and 10·2 months in the adalimumab group. No patients in either group had opportunistic infections (excluding oral candidiasis and tuberculosis). No malignancies were reported in the placebo group whereas one (1%) patient in the adalimumab group reported non-serious squamous cell carcinoma. The most common adverse events were arthralgia (12 [11%] patients in the placebo group and 27 [23%] patients in the adalimumab group), nasopharyngitis (16 [17%] and eight [16%] patients, respectively), and headache (17 [15%] patients in each group). Adalimumab significantly lowered the risk of uveitic flare or loss of visual acuity upon corticosteroid withdrawal in patients with inactive, non-infectious intermediate, posterior, or panuveitic uveitis controlled by systemic corticosteroids. No new safety signals were observed and the rate of adverse events was similar between groups. These findings suggest that adalimumab is well tolerated and could be an effective treatment option in this patient population. An open-label extension study (NCT01148225) is ongoing to provide long-term safety data for adalimumab in patients with non-infectious uveitis. AbbVie.

Efficacy and safety of adalimumab in patients with moderate to severe hidradenitis suppurativa: Results from PIONEER II, a phase 3, randomized, placebo-controlled trial

Efficacy and safety of adalimumab in patients with moderate to severe hidradenitis suppurativa: Results from PIONEER II, a phase 3, randomized, placebo-controlled trial

Efficacy and safety of adalimumab in patients with moderate to severe hidradenitis suppurativa. Our clinical experience

Efficacy and safety of adalimumab in patients with moderate to severe hidradenitis suppurativa. Our clinical experience

Adalimumab in the treatment of moderate-to-severe chronic plaque psoriasis in patients switching from other biologics.

Ample evidence shows that switching from one biological agent to another may prove effective when response to the first one is inadequate. Nevertheless, there are little data so far showing the efficacy and safety of adalimumab in patients with plaque psoriasis who previously received another biologic agent. We evaluated the 1-year effectiveness, safety and quality-of-life outcomes patients with psoriasis who had switched to adalimumab from other biologic therapies. Forty-two patients who participated in this Austrian multicenter study were treated with adalimumab over a 1-year period, after switching from efalizumab, infliximab or etanercept. Effectiveness was assessed using standardized tools for measurement of disease severity [Psoriasis Area and Severity Index (PASI) and Nail Psoriasis Severity Index (NAPSI)] and quality of life [Dermatology Life Quality Index (DLQI)]. The study endpoints were evaluated using the all-treated population. The mean percentage of improvement at the end of the study was 74.3% for PASI, 81.6% for DLQI and 83.6% for NAPSI, demonstrating a considerable benefit of treatment with adalimumab. The safety profile observed was consistent with previous clinical trials for adalimumab, and no new safety signals were observed. Adalimumab therapy in patients with plaque psoriasis previously treated with other biologic agents demonstrates effectiveness, safety and improvement in quality of life.

Efficacy and safety of adalimumab as the first and second biologic agent in juvenile idiopathic arthritis: the German Biologics JIA Registry.

To evaluate the efficacy and safety of adalimumab in patients with juvenile idiopathic arthritis (JIA). Baseline demographic and clinical characteristics and disease activity parameters were prospectively documented in the German Biologics JIA Registry. Efficacy was determined using the American College of Rheumatology (ACR) Pediatric (Pedi) response criteria and the Juvenile Arthritis Disease Activity Score based on a 10-joint count (JADAS-10). Safety assessments were based on adverse event reports from the responsible physician. Two hundred eighty-nine patients with a total of 1,046 visits were identified (435.7 patient-years). A high proportion of patients demonstrated a significant response to treatment, with a marked decrease in the JADAS-10 score in both the biologics-naive group (which consisted of patients who had not received therapy with a biologic agent prior to initiation of adalimumab) and the biologic-switcher group (which consisted of patients who had been treated with a different biologic agent prior to initiation of adalimumab). The median JADAS-10 score at treatment start was significantly higher in the biologics-naive group than in the biologic-switcher group (12.9 versus 8.5; P = 0.00044), although the score in the biologics-naive group was lower over the course of adalimumab treatment. ACR Pedi 30, 50, 70, and 90 scores were achieved in 63.4%, 61.0%, 48.8%, and 34.2% of biologics-naive patients, respectively, at 6 months of treatment, while ACR Pedi 30, 50, 70, and 90 scores were achieved in 47.6%, 38.1%, 21.9%, and 15.2% of biologic-switcher patients, respectively. Forty-eight patients experienced 222 adverse events (50.9 per 100 patient-years). Eleven were reported as serious (2.5 per 100 patient-years). No malignancies were observed during adalimumab exposure. There were 16 uveitis flares in 11 patients. Treatment was discontinued in 58 patients for the following reasons: inefficacy 11.1%, adverse events 5.2%, remission 4.5%, patient request 11.8%, and other reasons 7.9%. Adalimumab appears to be highly effective in children and adolescents with JIA who have been previously treated with biologic agents and in children and adolescents who switched biologic agents. The treatment is safe and its efficacy is similar to that of other biologic agents used to treat JIA. Few patients discontinued therapy due to intolerance or inefficacy.