Golimumab 50mg/0.5ml solution for injection pre-filled syringes

Paradoxical reactions (PRs) to biologic medications, such as psoriasis, arthritis, and inflammatory bowel disease (IBD), have been increasingly recognized. The aim of reporting this case is to establish an association between golimumab and exacerbation or new (de novo) IBD in patients with axial spondyloarthritis (SpA). Our case involves a young patient with juvenile-onset ankylosing spondylitis (AS) who developed de novo IBD following golimumab therapy for active spinal disease. The patient had no prior gastrointestinal (GI) symptoms, and AS symptoms significantly improved with golimumab. However, before the third dose, he experienced non-bloody diarrhea, mild abdominal cramping, and constitutional symptoms (fever, chills, and weight loss). Colonoscopy and biopsy confirmed unclassified IBD. The discontinuation of golimumab resulted in marked improvement in GI symptoms, but the recurrence of AS symptoms necessitated the initiation of infliximab, which resolved both AS and IBD symptoms. A comprehensive systematic literature review was conducted (from 2008 to October 2024) on Medical Literature Analysis and Retrieval System Online (MEDLINE) Complete/PubMed and Scopus databases using both Medical Subject Heading (MeSH) terms and keywords related to golimumab, SpA, and paradoxical IBD. Data from included cases were extracted by two researchers, and the quality assessment of case reports was performed using a standardized tool. Four cases of paradoxical IBD development following golimumab treatment in patients with pre-existing IBD were identified. This is the first reported case of de novo IBD development in a biologic-naïve patient with AS treated with golimumab. This case highlights the importance of prompt evaluation of gastrointestinal symptoms and early gastroenterology referral during biologic therapy.

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ObjectiveThe biologics for moderate to severe ulcerative colitis (UC) have expanded with an increasing array. We performed an updated network meta-analysis to evaluate and compare the relative efficacy and safety profiles of biologics in moderate to severe UC.DesignWe searched literature to 18 May 2024, to identify eligible studies. The clinical remission, clinical response, or endoscopic improvement, stratified by previous exposure or naive to biologics, and safety were assessed. A network meta-analysis was performed through the bayesian model, obtaining pairwise relative ratios (RR) and 95% confidence intervals (CI). The surface under the cumulative ranking probabilities (SUCRA) was used to rank the included agents for each outcome.ResultsA total of 23 trials (10,839 patients) were included. In induction therapy, based on achieving clinical remission and endoscopic improvement, infliximab 5 mg/kg ranked first. For clinical response, ustekinumab 6 mg/kg superior to other drugs. Infliximab 5 mg/kg demonstrated superior efficacy in biologic-naive patients, whereas ustekinumab 6 mg/kg was the most effective in biologic-exposed patients. No significant differences between active interventions were observed when assessing safety outcomes, except for visilizumab. In maintenance therapy, for clinical remission and endoscopic improvement, vedolizumab 108 mg every other week and vedolizumab 300 mg every 4 weeks ranked first respectively, with infliximab 5 mg/kg performed best in achieving clinical response. Regarding safety ranking, golimumab 100 mg was the lowest.ConclusionIn this network meta-analysis, infliximab and vedolizumab emerged as the most effective biologics for inducing and maintaining efficacy outcomes for patients with UC. Most drugs were found to be safe and well-tolerated, with ustekinumab and mirikizumab exhibiting particularly favorable safety profiles.

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ObjectiveTo assess the safety of tumor necrosis factor inhibitors (TNFi) during pregnancy, specifically in relation to infant infection rates, vaccine efficacy, and vaccine-associated adverse events in infants exposed to TNFi in utero and through breast milk.Data sourcesA comprehensive literature review was conducted using PubMed and Google Scholar. The review included retrospective studies, prospective studies, and systematic reviews published until June 2024, focusing on TNFi exposure during pregnancy and breastfeeding.Study selectionsStudies reporting on infant infection rates, vaccination outcomes, and adverse events following in-utero or breastfeeding exposure to TNFi agents, including certolizumab pegol, adalimumab, infliximab, etanercept, and golimumab. Narrative reviews were excluded, while systematic reviews were considered.ResultsThe review indicates that gestational exposure to TNFi does not increase the risk of severe infections in infants. Additionally, no significant rise in infections was found in infants exposed to TNFi through breast milk. Vaccination outcomes, including efficacy and adverse events, were comparable between exposed and unexposed infants. However, caution is advised when administering the Bacille Calmette-Guerin vaccine to infants exposed to TNFi, particularly within the first year of life.ConclusionTNFi appear to be safe during pregnancy and breastfeeding. The data indicate that TNFi does not increase the risk of severe infections or vaccine complications in infants, with the exception of the Bacille Calmette-Guerin vaccine, for which a more cautious approach is recommended. These findings reinforce the use of TNFi in women with inflammatory conditions who are pregnant or breastfeeding, providing benefits to both maternal and fetal health.

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BackgroundUveitis is a common extra-articular manifestation of ankylosing spondylitis (AS), and a systematic analysis of the effects of biologics on new-onset and recurrent uveitis is clinically important.MethodsWe conducted a network meta-analysis (NMA) to assess the impact of anti-TNF-α (adalimumab, etanercept, golimumab, and infliximab), IL-17 inhibitors (secukinumab, bimekizumab, and ixekizumab), and JAK inhibitors (tofacitinib and upadacitinib) on new-onset and recurrent uveitis. Phase II/III double-blind randomized controlled trials and cohort studies were included. The relative risk (RR) was estimated, and drug efficacy was ranked based on the surface under the cumulative ranking curve (SUCRA).ResultsA total of 17 articles with 18 studies and 11,529 AS patients were included. For new-onset uveitis, adalimumab reduced the risk significantly compared to etanercept and golimumab (RR: 0.30, 0.61), while etanercept increased the risk compared to golimumab and infliximab (RR: 2.03, 2.47). The SUCRA demonstrated that upadacitinib (84.0%) exhibited better efficacy, while ixekizumab (8.7%) was less effective than placebo (29.9%). For recurrent uveitis, adalimumab significantly reduced the risk compared to etanercept (RR: 0.70), while etanercept increased the risk compared to golimumab and infliximab (RR: 1.37, 1.70). Bimekizumab 160 mg and 320 mg were the most efficacious (SUCRA: 83.9%, 83.5%). A comprehensive analysis revealed that bimekizumab 320 mg and 160 mg were the most effective in reducing the incidence of uveitis. Ixekizumab and secukinumab were less effective than placebo.ConclusionJAK inhibitors were more effective for new-onset uveitis in AS patients. Inhibition of IL-17A (secukinumab and ixekizumab) alone might increase the risk of uveitis, while simultaneous inhibition of IL-17A and IL-17F (bimekizumab) significantly reduced the risk. Etanercept increased the risk of uveitis compared to other TNF-α inhibitors.

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BackgroundVarious treatments exist for nail psoriasis (NP). We determined the relative efficacy of various monotherapies through Bayesian network meta-analyses (NMAs).MethodsWe systematically reviewed the literature to identify eligible studies which-within the patient, intervention, comparator, outcome (PICO) context-determined the impact of biologic monotherapies on NP in terms of two outcome measures, namely, (1) the 16 to 24-week mean change in the Nail Psoriasis Severity Index (NAPSI) (i.e., outcome 1), and (2) the proportion who attained a Physician Global Assessment of fingernails (PGA-f) of "0" or "1" (i.e., "clear" or "almost clear") between 16 and 24 weeks (i.e., outcome 2). Our NMAs estimated the surface under the cumulative ranking curve (SUCRA) values and pairwise relative effects. We also determined relative effects of comparators that had never been compared for this condition, including "deucravacitinib 6mg daily", "risankizumab 150 mg at weeks 0, 4, 16", and "golimumab 2mg/kg at weeks 0, 4, then every 8 weeks".Results and conclusionWe identified 22 active comparators; "tofacitinib 10 mg twice daily" was ranked most efficacious in terms of 16 to 24-week mean change in NAPSI (SUCRA = 99.71%)-while "ixekizumab 160 mg at week 0 followed by 80 mg every 4 weeks" was ranked most efficacious (SUCRA = 95.67%) for proportion attaining PGA-f of 0 or 1 (i.e., outcome 2). Our analyses produced comparative evidence for the relative efficacy of monotherapies with various agents, including biologics and non-biologics. Our findings would guide clinical decision-making.

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