Adalimumab Therapy Research Articles

Comparative safety of infliximab and adalimumab on pregnancy outcomes of women with inflammatory bowel diseases: a systematic review & meta-analysis

BackgroundInflammatory bowel disease (IBD) is a condition that affects most of the digestive tract. There is no report of fertility reduction in medically managed IBD women compared with the general population. On the other hand, active IBD can lead to significantly decreased fertility. Over the previous 2 decades, anti-tumor necrosis factor (anti-TNF) has been an effective treatment for managing patients with IBD, increasing the use of infliximab and adalimumab in clinical practice. However, it is unclear which biologics are better for pregnant women with IBD.AimWe conducted a systematic review and meta-analysis for the risk of adverse pregnancy outcomes following treatment with infliximab and adalimumab in women with IBD.MethodsBibliographic databases were retrieved from their inception to July 2022. The results were adverse pregnancy outcomes, including congenital malformations and spontaneous abortion.ResultsA total of 8 studies included 527 pregnant women with IBD. Of these, 343 received infliximab, and 184 received adalimumab therapy. Compared to adalimumab, adverse pregnancy outcomes were not increased in infliximab therapy including congenital malformations and spontaneous abortion.ConclusionInfliximab and adalimumab therapy did not show the difference of risk in adverse pregnancy outcomes in women with IBD.Systematic review registrationhttp://www.crd.york.ac.uk/PROSPERO, identifier: CRD 42,021,277,869.

Adalimumab plus Conventional Therapy versus Conventional Therapy in Refractory Non-Infectious Scleritis.

Long-term systemic glucocorticoids and non-specific immunosuppressants remain the mainstay of treatment for refractory scleritis, and result in serious side-effects and repeated inflammation flares. To assess the efficacy and safety of additional adalimumab, patients diagnosed with refractory non-infectious scleritis were enrolled. They were assigned to the conventional-therapy (CT, using systemic glucocorticoids and other immunosuppressants) group or the adalimumab-plus-conventional-therapy (ACT) group according to the treatments they received. The primary outcome was time to achieve sustained remission, assessed by a reduction in modified McCluskey's scleritis scores. Other outcomes included changes in McCluskey's scores, scleritis flares, best-corrected visual acuity, and spared glucocorticoid dosage. Patients in the ACT group achieved faster remission than those in the CT group, as the median periods before remission were 4 months vs. 2.5 months (p = 0.016). Scleritis flares occurred in 11/11 eyes in the CT group and 5/12 eyes in the ACT group (p = 0.005). Successful glucocorticoid sparing was realized in both groups, but the ACT group made it faster. No severe adverse events were observed. Data suggest that adalimumab plus conventional therapy could shorten the time to remission, reduce disease flares, and accelerate glucocorticoid withdrawal compared with conventional therapy alone.

Prompt and Sustained Suppression of Intraocular Inflammation with Adalimumab in Pediatric Patients with Non-Infectious Uveitis Resistant to Traditional Managements: A 6-Month Follow-Up Research

ABSTRACT Purpose To assess the efficacy of adalimumab (ADA) on visual acuity (VA), ocular inflammation, vitreous haze and central macular thickness (CMT) in pediatric refractory non-infectious uveitis. Methods Thirty-one eyes of 16 pediatric patients with uveitis of various etiologies were treated with ADA. VA, intraocular active inflammatory cells, vitreous haze, and CMT were evaluated at the baseline and 2nd, 4th, 12th, and 24th weeks following ADA treatment. Results Twenty-three of 31 eyes had active and the remaining 8 eyes had inactive uveitis (with frequent relapse) before ADA therapy. VA (LogMAR) increased at 12th week following ADA treatment (p< .001). Intraocular inflammation degrees significantly improved within 4 weeks (p< .001). Vitreous haze decreased at fourth week and stabilized at 12th week (p= .038). CMT started to decrease within weeks and stabilized at 12th week (p= .006). Conclusions ADA was found to be safe and effective to suppress intraocular inflammation in pediatric non-infectious uveitis, which prevented sight-threatening complications.

A critical review of adalimumab for the treatment of moderate-to-severe active ulcerative colitis in children

Introduction Anti-TNF antibodies play a major role in treating IBD, both in adult and paediatric patients. While there is a large number of studies on efficacy and safety of infliximab in treating children and adolescents with UC, data on adalimumab (ADA) are scarce. Areas covered Here, we review published case reports, cohort and real time data as well as the first randomized trial, ENVISION I, using ADA for treating paediatric UC. Available evidence confirms good efficacy inducing and maintaining remission in children and adolescents with UC, with even higher response rates compared to adult UC. ENVISION I showed that in UC patients responding to ADA induction therapy almost half of the patients remained in remission after 52 weeks of therapy on high-dosing ADA (weekly administration). As already well experienced with other biologics, dosing schemes are different between paediatric and adult patients, with children often requiring higher dosing. Expert opinion: Further data are required to better understand how to optimize ADA therapy. The present and still growing evidence places sc. anti-TNF-medication as alternative first line therapy also for paediatric UC. This is also reflected by the preference for sc. medication of adolescent patients allowing less frequent and autonomous drug administration.

Adalimumab Therapy in Pediatric Crohn Disease: A 2-Year Follow-Up Comparing "Top-Down" and "Step-Up" Strategies.

European Crohn's Colitis Organization (ECCO) and the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) guidelines recommend the early use of anti-tumor necrosis factor (TNF) biologicals in pediatric Crohn disease (CD) patients with positive predictors for poor outcome. The objective of the present study was to compare early "Top-Down" use of adalimumab (ADA) immunomodulator/biologics-naive patients to conventional "Step-Up" management. One hundred and twenty consecutive patients with a confirmed diagnosis of CD and treated with ADA between 2008 and 2019 were included and allocated to the ADA-Top Down (n = 59) or ADA-Step Up group (n = 61). The primary endpoint was prolonged steroid-/enteral nutrition-free clinical remission at 24 months, defined by a weighted Pediatric Crohn's Disease Activity Index (wPCDAI) < 12.5. Clinical and biological data were collected at 12 and 24 months. At start of ADA, disease activity was comparable between the ADA-Top Down group and the ADA-Step Up group (wPCDAI = 31 ± 16 vs 31.3 ± 15.2, respectively, P = 0.84). At 24 months, the remission rate was significantly higher in the ADA-Top Down group (73% vs 51%, P < 0.01). After propensity score, the Top-Down strategy is still more effective than the Step-Up strategy in maintaining remission at 24 months [hazard ratio (HR) = 0.36, 95% CI (0.15-0.87), P = 0.02]. Patients in the ADA-Top Down group were mainly on monotherapy compared to patients in the ADA-Step Up group (53/55 vs 28/55 respectively, P < 0.001). Serum levels of ADA were higher in the ADA-Top Down group than in the ADA-Step Up group (12.8 ± 4.3 vs 10.4 ± 3.9 µg/mL, respectively, P < 0.01). There were no serious adverse events. Early use of ADA appears to be more effective in maintaining relapse-free remission at 2 years, while using it as monotherapy. These findings further favor the recommendation of early anti-TNF use in high-risk CD patients.

AVT02: An Adalimumab Biosimilar.

AVT02 (Hukyndra®, Libmyris®) is a biosimilar of the reference anti-tumour necrosis factor alpha monoclonal antibody adalimumab. It is approved for use in all indications for which reference adalimumab is approved. AVT02 has similar physicochemical and pharmacodynamic properties to those of reference adalimumab, and the pharmacokinetic similarity of the agent has been shown in healthy adult subjects. AVT02 demonstrated clinical efficacy similar to that of reference adalimumab in patients with chronic plaque psoriasis, and was generally well tolerated in this population. The tolerability, safety and immunogenicity profiles of AVT02 were similar to those of reference adalimumab. Switching from reference adalimumab to AVT02 appeared to have no impact on efficacy, safety or immunogenicity. The role of reference adalimumab in the management of immune-mediated inflammatory diseases is well established and AVT02 provides an effective biosimilar alternative for patients requiring adalimumab therapy.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40261-022-01196-w.

Real-life data on efficacy and safety of original Adalimumab and biosimilar Adalimumab (ABP 501) in pediatric rheumatic diseases

ABSTRACT Background We aimed to compare the efficacy and safety of the original product (OP) and biosimilar product (BP) of adalimumab in pediatric rheumatic diseases. Research design and methods The study group consisted of patients who had received original or biosimilar adalimumab (ABP 501) therapy for at least 3 months. The patients were divided into uveitis and arthritis groups based on the indication of adalimumab treatment. Assessment of disease activity was performed by Juvenile Arthritis Disease Activity Score in patients with juvenile idiopathic arthritis, and by standardization of uveitis nomenclature criteria in patients with uveitis. Results The study included 140 patients, of which 87 were treated with OP and 53 with BP. In the arthritis group, 26 (63.4%) and 20 (57.1%) patients reached inactive disease according to JADAS-27 in the original and biosimilar adalimumab groups, respectively. In the uveitis group the mean number of exacerbations throughout the treatment period was 0.84 ± 1.07 in the OP group, and 0.58 ± 0.79 in the BP group. There were 71 treatment-emergent adverse events in the OP group and 38 in the BP group. Conclusion There was no significant difference between the biosimilar and the original product in efficacy and safety.

Predictive Factors for Magnetic Resonance Imaging Changes Suggestive of Demyelination in Adult Patients with Uveitis Scanned Prior to Commencing Adalimumab Therapy

ABSTRACT Purpose To report the predictive clinical factors for abnormal magnetic resonance imaging (MRI) scans suggestive of demyelination by analysis of MRI’s performed for adult non-infectious uveitic patients prior to commencing adalimumab therapy. Methods Retrospective case review of 240 patients was conducted in a single tertiary institution between November 2017 and March 2020. Aetiology of underlying disease, clinical characteristics, and MRI outcomes were analysed. Results The presence of bilateral idiopathic intermediate uveitis (IIU) (p = .0048) and neurological symptoms (p = .028) were highly predictive of an abnormal MRI strongly suggestive of demyelination (MRSSD); 5 out of 64 scans (7.8%) with these clinical characteristics had MRSSD. Conclusions Tumor necrosis factor antagonist-induced demyelination is a concern in adalimumab use. We propose an MRI screening protocol to identify those at high risk of demyelination; positive results can be maximised by screening all patients with IIU and those with neurological symptoms.

Biological therapy of uveitis in children

Introduction: Biological therapy can be used in uveitis in children since 2016. With ophthalmological indication only adalimumab therapy can be started. Adalimumab is a monoclonal antibody that inhibits tumor necrosis factor alpha.Objective: To summarize our experience with patients receiving adalimumab for pediatric non-infectious uveitis.Patients and methods: We investigated our juvenile patients of non-infectious uveitis treated with adalimumab be-tween 2017 and 2021 in a retrospective case series at the Department of Ophthalmology, Szeged University. Results: Between 01 January, 2017 and 31 May, 2021, we examined 46 children with uveitis. The mean age of these 23 girls and 23 boys was 11 years. 21 of them had juvenile idiopathic arthritis, 14 had infectious uveitis, 3 had hae-matological disorders, 8 had idiopathic uveitis. Adalimumab was given to 11 patients because of severe, chronic uveitis. There were 3 boys and 8 girls, their mean age was 10 years. Adalimumab was given according to the licence of the European Medicines Agency. Indication was anterior uveitis at 6 children, panuveitis at 5 children. Adali-mumab can be given to children over 2 years, who have chronic, non-infectious, anterior uveitis. Children with panuveitis received the therapy by the help of a pediatric rheumatologist.Conclusion: The significance of pediatric uveitis and its therapy is emergent. Our aim was to preserve vision and de-crease the possibilities of side effects and to provide a better life for these uveitic children. Early diagnosis, adequate therapy and regular ophthalmological check-ups are important. Children treated with adalimumab have good visual acuity due to the effectiveness of the therapy. No new ocular side effect was detected at the children treated with adalimumab.

Case report: Safety and efficacy of adalimumab in treating difficult-to-treat rheumatoid arthritis in a human immunodeficiency virus-positive patient, one year follow-up

Rheumatoid arthritis (RA) is a joint-disabling inflammatory disease associated with the pathology of synovitis. Some patients with RA are difficult to treat, using disease-modifying anti-rheumatic drugs (DMARDs). Biology and targeted synthetic DMARDs (b/tsDMARDs) are options for patients with RA. Acquired immunodeficiency syndrome (AIDS) is an infectious disease caused by the human immunodeficiency virus (HIV). Adalimumab is an anti-tumor necrosis factor therapy commonly used in patients with RA. However, there are no reports or related data on patients with RA-HIV/AIDS treated with adalimumab are available. In this report, we described the first successful case of a 60-year-old HIV-positive woman with difficult-to-treat RA treated with ADA after being screened for hepatitis virus, latent tuberculosis (LTBI), and other infections. She contracted HIV from sexual exposure while on adalimumab therapy. As the patient was resistant to first-line DMARDs, she continued adalimumab along with the initiation of highly active antiretroviral therapy (HAART). The patient was treated with adalimumab therapy for a year; her CD4+ lymphocyte count was normal, HIV-1 RNA decreased, and no new infections were triggered. The patient achieved clinical remission of RA. In conclusion, adalimumab is a safe option for patients with RA-HIV and may slow the progression of HIV infection. Furthermore, HAART has the potential to reduce joint pain and fatigue in patients with difficult-to-treat RA.ConclusionsAdalimumab is a safe option for patients with RA-HIV, and may slow down the progression of HIV infection. The HAART therapy has the potential to reduce joint pain and fatigue in patients with difficult-to-treat RA.

Non-medical switch from the originator to biosimilar and between biosimilars of adalimumab in inflammatory bowel disease – a prospective, multicentre study

IntroductionClinical data on the efficacy and safety of non-medical switch between adalimumab(ADA) biosimilars are limited. AimsThe aim of this study was to evaluate medium-term clinical efficacy, drug sustainability and safety comparing non-medical switches from the originator to biosimilar ADA, and between ADA biosimilars. Methods276 consecutive patients on maintenance ADA therapy (n = 205 Crohn's disease, n = 71 ulcerative colitis) were included. Data on clinical efficacy, biomarkers and adverse events were collected at four time points: 8–12 weeks prior switch, at baseline/switch, 8–12 weeks and 20–24 weeks after switch. Drug survival was evaluated after a median 40(IQR:35–42) weeks follow-up. ResultsA total 174 patients underwent a non-medical switch from the originator to a biosimilar, and 102 patients had a biosimilar-to-biosimilar switch. No significant difference was found in clinical remission rates at any time point in patients switching from originator to biosimilar(87.3%/88.5%/86.5%/85.7%) or biosimilar to biosimilar(74.5%/78.4%/85.3%/79.8%). Mean C-reactive protein levels remained unchanged in both cohorts(p = 0.856 and p = 0.525). Drug survival was similar between the two cohorts with a probability of 91.6%(SE: 2.2) and 87.0%(SE:3.4) to stay on drug after 40 weeks(log-rank:0.96; p = 0.327). Five cases of injection related adverse events were reported. ConclusionClinical benefit was sustained following non-medical switch from originator to biosimilar, or between biosimilars in adalimumab treated IBD patients.

Adherence to and Persistence with Adalimumab Therapy among Swedish Patients with Crohn's Disease.

Objectives: (1) to determine the adherence and persistence rates of adalimumab therapy among Swedish patients with Crohn’s disease (CD), and (2) to compare self-administration devices to predict the medication adherence and persistence. Methods: We conducted a retrospective analysis of the Swedish National Board of Health and Welfare database during a unique time period, when both the pen and the syringe were available. The pen was proposed to indicate a larger extent of internal control, according to health locus of control. Medication adherence was defined as a medication possession ratio (MPR) ≥ 0.8. A patient was considered nonpersistent if the time between any two dispensing records, minus the days of supply dispensed exceeded 180 days. The predictors of adherence were evaluated using a logistic regression, and the predictors of persistence were evaluated using a Cox proportional hazards model. Results: Among the 1083 patients studied, 89% were adherent and 77% were persistent. The patients using the pen and the patients treated in gastroenterology centers were more likely to be adherent and less likely to be nonpersistent. Conclusions: The adherence rate to adalimumab therapy was 89% and the one-year persistence rate was 70%. The pen and treatment in a gastroenterology center had a positive impact on the adherence and persistence among Swedish patients with CD.

Treating Psoriatic Arthritis By TNF –Α Inhibitors: A Case Study

Psoriatic arthritis (PsA) is a heterogeneous seronegative chronic inflammatory spondyloarthritis associated with psoriasis. Doctors consider PsA hard in complex treatment. The purpose of the study is to perform the analysis of clinical data and to identify the features of psoriatic arthriti's and selecting drug therapy.The patient's condition clinical assessment has carried out by using clinical, laboratory and instrumental methods with calculating the Psoriasis Area and Severity Index (PASI), the CASPAR diagnostic criteria and the genetically engineered biological drugs treatment.In the clinical case we studied, a patient with a history of psoriasis has first diagnosed with widespread skin psoriasis at the age of 12, when he carried out medicamentous therapy combined with PUVA. Despite the use of glucocorticosteroids, no complete regression of psoriasis has observed, and the PASI score was 35.3- 36.3 points. At the age of 30, the patient developed lower back pains, enthesitis, the PASI score was of 37.1 points. Nonsteroidal anti-inflammatory drugs were added to the treatment. At the age of 42, he was diagnosed with psoriatic arthritis, activity III, stage II, dactylitis, enthesites, the PASI index was 31.3 points; right-sided active sacroiliitis - radiologically stage 1 (BASDAI 4.2 points), FCS 2-3". According to the CASPAR criteria, 4 points were obtained at the time of the disease diagnosis (current psoriasis - 2 points, familial psoriasis - 1 point, negative rheumatoid factor - 1 point). In 2016, at the age of 48, Adalimumab therapy has started according to the scheme in combination with Methotrexate, as a result it was possible to achieve psoriatic arthritis remission and the skin rashes' regressed and 0 PASI score.The psoriatic arthritis therapy with the use of Adalimumab - TNF-α - inhibitor contributed to the disease's long-term stable remission and completed the psoriatic skin rashes regression.

State of the art of blue light effects on hidradenitis suppurativa: a concise systematic review

Introduction: In the setting of inflammatory diseases, hidradenitis suppurativa (HS), or acne inversa, is an immune-mediated skin disease with a prevalence of 0.1-1% and characterized by nodules and abscesses in the armpits, groin, and inframammary areas, which may evolve for fistulas and scars. Still, an update is needed on the recent understanding of the pathogenesis of HS, including the central role of inflammatory cytokines and other contributing factors such as genetics, hormones, and pathogenic microorganisms. As an innovative approach, antimicrobial blue light in the 400-470 nm spectrum has demonstrated its intrinsic antimicrobial properties resulting from the presence of endogenous photosensitizing chromophores in pathogenic microorganisms. Objective: To carry out a narrative and systematic review of the literature to explore the main clinical and experimental results of the use of photobiomodulation with blue light for the treatment of hidradenitis suppurativa by antibacterial action. Methods: The present study followed a model of narrative and systematic review, according to PRISMA rules, to gather the main information about the efficiency and safety of blue light in the treatment of HS. The research was carried out from January 2018 to May 2019 and developed based on Google Scholar, Scopus, PubMed, Scielo, and Cochrane Library. The quality of the studies was based on the GRADE instrument and the risk of bias was analyzed according to the Cochrane instrument. Results: Microorganisms are less able to develop resistance to antimicrobial blue light than to traditional antibiotics, due to the multi-targeting characteristics of antimicrobial blue light. Furthermore, it is well accepted that antimicrobial blue light is much less harmful to host cells than UV irradiation. Clinical studies have presented scientific evidence of treatment for HS with light-based therapy, showing efficacy and safety through articles published in quality journals in scientific evidence. A meta-analysis published in 2019, based on the quality of the evidence, showed that the most recommended treatments for HS include adalimumab and laser (blue light) therapy. For intense pulsed light with blue light, two RCTs reported improvements in HS-LASI scores and the Dermatology Quality of Life Index. Conclusion: The use of blue light for dermal treatments, particularly for HS, is finding an increasing role in dermatology. However, more robust and consistent studies are still needed to better demonstrate the antibacterial effects of blue light on HS.

Treatment of Crohn’s disease in children with adalimumab after being infected with SARS-CoV-2 at Children’s Hospital No. 2: a case report

Covid-19 disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), may lead to a severe inflammatory response or cytokine storm. Immune dysfunction in untreated Crohn’s disease may augment the risk for a severe inflammatory response to Covid-19. It is estimated that about 2% of severe children need to be hospitalised and the mortality rate is about 0.08%. Crohn’s disease most commonly occurs in the small intestine and the colon. It can affect any part of the gastrointestinal (GI) tract, from the mouth to the anus. Crohn’s patients on immunosuppressive medical therapy may encounter an increased SARS-CoV-2 infection risk. By contrast, immunosuppressive therapy may also have a potential benefit on clinical outcomes in Covid-19, since it may suppress not only mucosal inflammation but also the severe acute respiratory syndrome SARS-CoV-2-driven systemic inflammatory immune response. Adalimumab therapy can effectively treat both pediatric Crohn’s disease and multisystem inflammatory syndrome in children temporally associated with coronavirus disease 2019 infection. However, the management and follow-up plan still needs more consensus because it almost depends on steroids, adalimumab, and other drugs. Covid-19 in patients with Crohn’s disease has not been well documented in the literature. Therefore, in this study, the authors reported a case of a pediatric Crohn’s disease successfully treated with adalimumab after infected coronavirus 2 at Children’s Hospital No. 2 from September 7, 2021 to November 4, 2021.

Cost Effectiveness of Subcutaneous Vedolizumab for Maintenance Treatment of Ulcerative Colitis in Canada.

Background and ObjectivesUlcerative colitis is highly prevalent in Canada and cost-effective ulcerative colitis therapies are warranted. Vedolizumab subcutaneous (SC) formulation was recently approved for ulcerative colitis maintenance therapy. We assessed vedolizumab SC cost effectiveness vs conventional and advanced therapeutics in patients with moderately to severely active ulcerative colitis from a Canadian public healthcare payer perspective.MethodsA hybrid decision tree/Markov model was developed to evaluate vedolizumab SC costs, quality-adjusted life-years, and cost effectiveness vs conventional therapy, adalimumab SC, infliximab intravenous, golimumab SC, tofacitinib, ustekinumab SC, and vedolizumab intravenous. This model predicts the number of patients achieving clinical response and remission after treatment induction, and sustained benefit during maintenance treatment. To account for statistical uncertainties, the base-case analysis was conducted in a probabilistic manner. Scenario analyses examined the impact of previous treatment with anti-tumor necrosis factor agents, dose escalation, loss of efficacy, and treatment adherence.ResultsIn the base-case analysis, conventional therapy was the most cost-effective therapeutic option in the overall population. Vedolizumab SC was cost effective and dominant compared with other advanced therapies (adalimumab, golimumab, infliximab, tofacitinib 5 mg, ustekinumab, and vedolizumab intravenous). The annual vedolizumab SC cost per patient was reduced vs ustekinumab SC, tofacitinib 5 mg, vedolizumab intravenous, and golimumab SC by $47,024, $3251, $2120, and $2004 (Canadian dollars), respectively, and exceeded that of infliximab, adalimumab, and conventional therapy by $582, $3293, and $41,024, respectively. Among the treatments, vedolizumab SC generated the highest quality-adjusted life-years overall (14.21), which translated into the best incremental cost per quality-adjusted life-years gained over conventional therapy in the overall population ($109,374) and in anti-tumor necrosis factor-naïve and anti-tumor necrosis factor-experienced patients ($41,658/$114,287).ConclusionsConventional therapy offered the most cost-effective therapeutic option followed by vedolizumab SC. Based on a $50,000/quality-adjusted life-year threshold, vedolizumab was cost effective in anti-tumor necrosis factor-naïve patients but not the overall population also when compared to conventional therapy.Graphical abstract Supplementary InformationThe online version contains supplementary material available at 10.1007/s41669-022-00331-9.

Adalimumab in Treating Refractory Livedoid Vasculopathy.

Livedoid vasculopathy is a chronic, recurrent skin disorder. It seriously affects the quality of patients’ life. However, the pathogenesis has not been fully identified yet. Here, this retrospective study describes the successful use of anti-TNF-α agent adalimumab in three cases of refractory livedoid vasculopathy, which has not been reported previously. In addition, we provide some clinical evidence that adalimumab therapy is efficient in improving skin lesions and relieving the pain of livedoid vasculopathy.

Search of official nationwide database in Japan for adverse events associated with disease-modifying antirheumatic drug therapies: focus on therapies in combination with methotrexate

ABSTRACT Background Disease-modifying antirheumatic drugs (DMARDs) are essential for rheumatoid arthritis (RA) therapy. The adverse events (AEs) evaluation should focus on that methotrexate (MTX) is frequently prescribed in combination with others (combination MTX). Methods A search of the website of the official Japanese Agency for AEs, including lymphoproliferative disease (LPD), cytopenia, interstitial pneumonia, infectious pneumonia other than Pneumocystis jirovecii pneumonia (PCP) (i-Pn), and PCP, associated with MTX, tacrolimus, adalimumab, tocilizumab, and abatacept therapies reported from 2014 to 2016 was performed. Number of each AE cases and its ratio to total number of AEs cases were examined. Combination MTX was checked for RA cases. Results A total of 8874 cases were listed. In 3955 MTX cases, LPD was most frequent (36.4%). In any of the other four DMARDs cases, i-Pn was most frequent (4.2 ~ 15.3%); PCP cases showed most frequent combination MTX (94.4%). In total, including cases reported for MTX therapy, 98.2% of LPD and 97.6% of PCP cases had MTX, and less than 90% of the other AEs cases had MTX. Conclusion LPD was by far the most frequent AE associated with MTX therapy. PCP was strongly associated with combination MTX. For any of the other four DMARDs, i-Pn was most frequent.

Real-World outcomes of adalimumab in adults with non-infectious uveitis.

ABSTRACTPurposeTo present real‐world adalimumab (ADA) efficacy and safety outcomes in non‐infectious uveitis (NIU) from a single United Kingdom (UK) tertiary centre.MethodsRetrospective review of adult patients with NIU treated with ADA. Data were collected at baseline, 6 and 12 months. The primary goal was to evaluate the rate of treatment failure, using the VISUAL‐I/II studies criteria, during 12 months of follow‐up. Secondary aims were to quantify corticosteroid‐sparing effect; to identify safety issues; to assess change in visual acuity; to identify reasons for treatment failure and to compare treatment outcomes at 6 and 12 months for patients classified as active or inactive at baseline.ResultsFifty‐one patients (102 eyes) with mean age of 48.3 years were included. One third had a known underlying systemic disease and 47.6% had panuveitis. The most common indication for ADA was failure to respond to oral immunosuppression. Treatment failure occurred in 9/51 patients (10 eyes) after 6 months and 13/51 (20 eyes) patients after 12 months. The need for rescue treatment in the 12 months prior to ADA was significantly associated with treatment failure at 12 months. The mean prednisolone dosage was &lt;10 mg/day at 6 and 12 months. There were no serious adverse events.ConclusionPatients with NIU who received ADA therapy for 12 months were likely to achieve disease control, to stabilize or improve visual acuity, to experience a reduction in immunosuppression and to reduce corticosteroid dosage. No new safety events were observed.

Risperidone combination therapy with adalimumab for treatment of chronic schizophrenia: a randomized, double-blind, placebo-controlled clinical trial.

This study aimed to investigate the efficacy and safety of antitumor necrosis factor-alpha (TNF-α) therapy using adalimumab in patients with chronic schizophrenia. This is a randomized, double-blind, placebo-controlled clinical trial carried out at Roozbeh Hospital (Tehran, Iran) from June 2020 to October 2021. The patients were randomly divided into two parallel adalimumab + risperidone and placebo + risperidone groups. Participants in the intervention group received adalimumab subcutaneous injection (40 mg) by pen-injector at weeks 0 and 4. Using the Positive and Negative Symptoms Scale (PANSS), patients' positive and negative symptoms were assessed at weeks 0, 4, and 8. Forty patients (20 in each group) were included. PANSS total (t = 4.43, df = 38, P < 0.001), negative (t = 2.88, df = 38, P = 0.006), and general psychopathology (t = 4.06, df = 38, P < 0.001) scores demonstrated a significantly greater decline in adalimumab compared with the placebo group from baseline study endpoint. However, improvement of PANSS positive subscale scores showed no significant difference from the baseline study endpoint. There was no significant between-group difference regarding levels of C-reactive protein, interleukin (IL)-1β, TNF-α, IL-6, and IL-8 at baseline and also at the week 8 visit (P > 0.05 for all). The current study found adalimumab adjunctive therapy effective in treating schizophrenia, particularly its negative and general psychopathology symptoms, with no side effects.