Filgotinib side effects The results for tofacitinib and upadacitinib show some inconsistency and more data are needed. . The rate of side effects was similar in people taking filgotinib and people taking placebo. Get the latest medication information and prescription drug insights today! Effect of other medicinal products on filgotinib: Filgotin is primarily metabolised by carboxylesterase 2 (CES2), which can be inhibited in vitro by medicinal products such as fenofibrate, carvedilol, diltiazem or simvastatin. Filgotinib (Jyseleca) is a new oral janus kinase (JAK) inhibitor that has recently been approved by NICE for moderate or severe rheumatoid arthritis after failure of other disease-modifying antirheumatic drugs (DMARDs). Jan 22, 2025 · P0611 Effectiveness comparisons between tofacitinib, filgotinib and upadacitinib in ulcerative colitis: results from the JAKARTA real-world evidence multicenter study The purpose of this study is to see whether the study drug (filgotinib) helps to treat axSpA and how safe it is in terms of side effects. May 31, 2022 · Filgotinib (GS-6034, formerly GLPG0634; Jyseleca®) is an oral, preferential Janus kinase (JAK)-1 inhibitor. 10 5. Diagnosed November 2020. JAKi tested for atopic dermatitis. Mar 4, 2025 · Objectives Long-term safety is fundamental for treatment decision-making. B. Aims: Filgotinib (GS-6034, formerly GLPG0634) is an oral, selective Janus kinase 1 (JAK1) inhibitor that showed early response and sustained efficacy in patients with rheumatoid arthritis and with Crohn's disease. Know about technical details of Filgotinib (USAN/INN) like: chemical name, chemistry structure, formulation, uses, toxicity, action, side effects and more at Pharmacompass. Results: The biomarker analysis set included 598 biologic-naive patients and 592 biologic-experienced patients. The most common serious adverse reactions are serious infections. Understanding Filgotinib Maleate side effects and interactions: Key to managing treatment, awareness of potential side effects and drug interactions is crucial for patient safety. Changes in patient bloodwork have been observed with all three JAKi, with some minor differences. Here, we report the one-year follow-up results of filgotinib in patients with UC. Filgotinib (GS-6034, formerly GLPG0634; Jyseleca ®) is an oral, preferential Janus kinase (JAK)-1 inhibitor. Janus kinase inhibitors (JAKis) are a novel group of orally administered, small molecule drugs that work by attenuating multiple cytokine signalling pathways to mediate dysregulated immune responses involved in the pathogenesis of IBD. Feb 1, 2025 · Effect of filgotinib vs. Key Points • … Jan 12, 2024 · Janus kinase (JAK) inhibitors, including tofacitinib, baricitinib, upadacitinib and filgotinib, are increasingly used in the treatment of rheumatoid arthritis (RA). It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. The date you started filgotinib: If you get any side effects, talk to your doctor, pharmacist or nurse. Common side effects may include: Upper respiratory tract infections (nose, throat or the windpipe) Lung infections (pneumonia and bronchitis) Shingles Influenza Bladder infection (cystitis) Increased liver enzymes or muscle enzymes in Filgotinib is a selective JAK1 inhibitor with a triazolpyridine core structure developed by Galapagos NV and Gilead Sciences (Fig. The FDA rejected the filling for approval of Filgitinib. It can help to reduce the symptoms of ulcerative colitis and reduce your need for steroids. Filgotinib seems to be generally safe and well tolerated, compared with a placebo, there was no evidence showing an increased risk of opportunistic infections or other correlative side effects [158]. Conclusion According to our preliminary data, Filgotinib was effective, safe and well tolerated in the treatment of articular involvement in patients affected by SSc overlap RA. , there was no worsening of anemia [JAK‐2 inhibition related], no effects on liver transaminases, and no increase in low‐density lipoprotein or total Know about technical details of Filgotinib (GLPG0634) like: chemical name, chemistry structure, formulation, uses, toxicity, action, side effects and more at Pharmacompass. The clinical relevance of this interaction is unknown. See the end of section 4 for how to report side effects. Methods Patients with moderate-to-severe active RA and an inadequate response to methotrexate (MTX) were randomized to daily placebo or filgotinib 50 mg, 100 mg, or 200 mg as add-on therapy to Results suggest that once daily filgotinib 200 mg for 13 weeks has no measurable impact on semen parameters or sex hormones in men with active IBD or inflammatory rheumatic diseases. JAK1 selective drugs, upadacitinib and filgotinib, have broadly come with the same overarching safety recommendations as other immunosuppressive drugs Side Effect: What is the most common adverse reactions/ side effects of Filgotinib? The most common side effects of Filgotinib are: Nausea, Upper respiratory tract infections, Urinary tract infections, Dizziness. PACKAGE LEAFLET Package leaflet: Information for the patient Jyseleca 100 mg film-coated tablets Jyseleca 200 mg film-coated tablets filgotinib This medicine is subject to additional monitoring. Side effects of specific interest for JAK inhibitors such as herpes zoster infections, pulmonary embolism and cardiovascular events in general occur at a low range. May 24, 2021 · Abstract Filgotinib (Jyseleca) is a new oral janus kinase (JAK) inhibitor that has recently been approved by NICE for moderate or severe rheumatoid arthritis after failure of other disease-modifying antirheumatic drugs (DMARDs). A treatment effect of filgotinib 200 mg vs placebo on the achievement of a combined rectal bleeding subscore of 0 and stool frequency subscore ≤1 was observed by day 9 in biologic-naive patients (18. Jyseleca is used alone or with another medicine, methotrexate, after treatment with one or more disease-modifying anti-rheumatic drugs (DMARDs) has not worked well enough or ha caused unacceptable side effects. [3][6][7] Filgotinib maleate, a Janus kinase (JAK) inhibitor, is commonly prescribed for treating moderate to severe rheumatoid arthritis and other autoimmune conditions. Positive results, in absence of severe side effects when using topical JAKi, could enormously help young patients in which the application of topical corticosteroids and systemic immunosuppressive drugs are often precarious. Jul 14, 2024 · We comprehensively review antidiabetic medications, including their mechanisms of action, systemic effects, side effects, and, most importantly, how these medications affect the risk, progression, and management of DR and other ocular diseases. By modulating the immune system to control the autoimmune disease, it also inherently reduces the body’s capacity to fight infections and perform its normal surveillance functions. Oral Administration: Unlike most biologic DMARDs, JAK inhibitors are small-molecule drugs taken orally, which is often preferred by patients and allows for more rapid treatment adjustments Effect of other medicinal products on filgotinib: Filgotinib is primarily metabolised by carboxylesterase 2 (CES2), which can be inhibited in vitro by medicinal products such as fenofibrate, carvedilol, diltiazem or simvastatin. Filgotinib, the rheumatoid arthritis (RA) oral drug that never made it to the U. The therapeutic guidelines are proposed to provide an evidence-based approach to combining JAK inhibitors with conventional agents to treat various autoimmune dermatoses. Edyta Tulewicz-Marti (Poland) Study Summary This was a multicenter real-world retrospective cohort study of the effectiveness and safety of upadacitinib (UPA) and filgotinib (FIL) in ulcerative colitis. 10 Food does not appear to have a significant effect on the As efficacy and safety data emerge, differences between JAK inhibitor subclasses are appearing. Janus kinase (JAK) inhibitors, upadacitinib, tofacitinib, and filgotinib, have demonstrated efficacy in UC, though real-world comparisons remain limited. g. Been flaring basically the whole time. May 2, 2023 · Supplemental material Effects of filgotinib on semen parameters and sex hormones in male patients with inflammatory diseases: results from the phase 2, randomised, double-blind, placebo-controlled MANTA and MANTA-RAy studies Jan 22, 2025 · Moderate-to-severe Ulcerative Colitis (UC) often requires advanced treatments. May 20, 2019 · Filgotinib is rapidly absorbed after oral administration. This guide assists health professionals in effectively advising patients on Filgotinib - Oral related inquiries. Several proinflammatory and neutrophil activation biomarkers may be early mediators of filgotinib treatment effects. No improvement Dec 4, 2024 · Conclusions Filgotinib significantly impacted circulating biomarkers related to UC pathology. org Everyone. But they do not state a time limit. Feb 13, 2023 · Effects of filgotinib on semen parameters and sex hormones in male patients with inflammatory diseases: results from the phase 2, randomised, double-blind, placebo-controlled MANTA and MANTA- RAy studies Jul 23, 2019 · Two other compounds that are similar in mechanism of action to filgotinib but that impede JAK enzyme family members less selectively are licensed in the United States for use by rheumatoid arthritis patients, but only at low doses or with warning labels due to side effects. 10 Median peak plasma concentrations occurred 2-3 hours post-dose for filgotinib and 5 hours post-dose for GS-829845. Jun 1, 2022 · Filgotinib could be used at 3 different positions in the treatment pathway 3. However, data comparing eficacy and safety of filgotinib and upadacitinib are scarce. Aug 28, 2021 · We have discussed specific side-effects of JAK inhibitors and have highlighted them in the table (with a haematology focus) and panel 2 (rheumatology focus). See section 4. It works by blocking a specific enzyme (JAK1) involved in inflammation, helping reduce joint pain, swelling, and This medicine has been prescribed for you only. Jun 1, 2019 · Objectives: The aim of this study is to describe and characterize the ophthalmological side effects of JAK inhibitors (JAK inhib) in patients with rheumatoid arthritis (RA) from European pharmacovigilance (PV) data. Filgotinib works by blocking Janus kinase 1, an intracellular protein involved in inflammatory signalling processes. We designed the MANTA and MANTA-RAy trials with global health agencies to find out if filgotinib decreases the Results The current preliminary data have shown that filgotinib is safe and effective in inducing clinical end endoscopic response in both biologic-naïve and biologic-experienced patients with moderate-to-severe UC, also with high inflammatory burden at baseline. Overview of: European Medicines Agency. 10 Steady-state concentrations can be observed in 2-3 days for filgotinib and in 4 days for GS-829845. I am currently on Vedolizumab (self injections every 2 weeks) and have been since May. The short-term safety, efficacy, and patient-reported outcomes (PROs) with filgotinib from Phase 2b/3 clinical trials (DARWIN 1 and 2; FINCH 1, … Oct 8, 2025 · A detailed clinical guide on Jyseleca 100mg (Filgotinib), a JAK inhibitor for treating rheumatoid arthritis and ulcerative colitis. Our Helpline can answer general questions about treatment options and can help you find support from others with the conditions. They may not occur at all. However, data comparing efficacy and safety of filgotinib and upadacitinib are scarce. Read all of this View filgotinib information, including dose, uses, side-effects, renal impairment, pregnancy, breast feeding, contra-indications and monitoring requirements. market but is sold across Europe, Great Britain, and Japan, remained effective for 3 years for most registration trial participants who continued in a long-term extension study, researchers said. Additionally, some studies have shown positive effects on skin lesions associated with psoriasis, further supporting its dual role in Jul 16, 2025 · Jyseleca 200 mg film-coated tablets Active Ingredient: filgotinib maleate Company: Alfasigma UK Limited (formerly Galapagos Biotech Limited) See contact details Mar 23, 2018 · Background The aim was to assess patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) treated with filgotinib during two phase 2b, 24-week, randomized, placebo-controlled studies. Filgotinib may be an option for patients with various types of uveitis who do not respond to treatment with conventional methods, such as prednisone or a corticosteroid, according Inflammatory bowel disease (IBD) commonly requires immunosuppressive treatments to induce and maintain durable remission. Preferential inhibition of JAK1 modulates a subset of proinflammatory cytokines within the JAK-signal transducer and activator of transcription pathway, which differ from those inhibited by JAK2 or JAK3. When the SMC recommends a treatment option, they expect NHS boards in Scotland to make it available. Participants often experience reductions in tender and swollen joint counts, along with improvements in physical function and quality of life. These medicines should be The benefits with Jyseleca are its ability to reduce the symptoms of rheumatoid arthritis. Methods Data were integrated from all phase II and III trials that have Aug 1, 2021 · Objective The long-term safety and efficacy of filgotinib (from phase II studies), with or without methotrexate (MTX), for the treatment of patients with rheumatoid arthritis was assessed in DARWIN 3, a long-term, open-label extension study ([ClinicalTrials. Table 3. Sep 29, 2025 · This article covers its mechanism of action, indications, dosage, a thorough analysis of side effects including serious warnings, drug interactions, and safety information. The aim of the present study was to investigate the impact of age and renal impairment (RI) on the pharmacokinetics (PK) of filgotinib and its main metabolite. 8% vs 9. In the SELECTION trial, one case of pulmonary embolism occurred with filgotinib 200 mg induction, and three venous thrombosis cases Oct 29, 2024 · Filgotinib, the rheumatoid arthritis (RA) oral drug that never made it to the U. Find patient medicine information on Filgotinib - Oral, including indications, side effects, drug interactions and more. It may be used either as monotherapy or in Oct 21, 2025 · 5. Filgotinib: Indication, Dosage, Side Effects - MEDICINE FOR WORLDIndication: Filgotinib, generic JYSELECA is a prescription medicine used to treat treatment of of moderate to severe active rheumatoid arthritis in adult patients who have had an inadequate response to, or are intolerant of, one or more disease-modifying anti-rheumatic drugs (DMARDs). MANTA (NCT03201445) and MANTA-RAy (NCT03926195) Sep 7, 2025 · The Side Effects of Jyseleca (Filgotinib) A comprehensive clinical overview of Jyseleca (Filgotinib), detailing its serious side effects, indications, drug interactions, and essential safety warnings for patients with rheumatoid arthritis and ulcerative colitis. Dec 23, 2022 · Discover the efficacy and safety of Filgotinib, a novel JAK1 inhibitor, in treating rheumatoid arthritis at Conquest Health, based on insights from recent clinical trials. Jan 22, 2025 · We previously reported that upadacitinib (UPA) demonstrated higher effectiveness than filgotinib (FIL) in the treatment of ulcerative colitis (UC) [1]. Have been on mesalazine (granules + enemas), Azathioprine, Prednisolone, Adulimumab and currently on Vedolizumab. Clinical remission at 8 weeks Hey there, looking for some advice from anyone who has experience with Filgotinib? Some context: 20 years old. Common Side Jyseleca (filgotinib) vs Rinvoq (upadacitinib) | Everyone. Filgotinib (FIL), in particular, is the newest member of the JAKi class and exerts its therapeutic effects by selectively targeting and inhibiting Apr 10, 2025 · Effects of filgotinib on biomarker levels, including week 4 biomarker changes that may mediate week 10 clinical improvements, were assessed. Objective: To evaluate the effects of filgotinib vs placebo on the signs and symptoms of RA in a treatment-refractory population. Mar 30, 2023 · All the studies between 2013 and 2021 describing the mechanism of action, pharmacokinetics, efficacy, or side-effects of JAK inhibitors were identified. FIL200-treated CDC achievers had better long-term outcomes than non-achievers. Jul 12, 2024 · One of the most common side effects of filgotinib maleate is an increased risk of infections. Most people don’t have any side effects, and for those who do, they aren’t usually serious. Design, setting, and participants: The HUMBOLDT trial was a double-masked, placebo-controlled, phase 2, randomized clinical trial conducted from July 2017 to April 2021 at 26 centers in 7 countries. placebo on clinical response in patients with moderate to severe rheumatoid arthritis refractory to disease-modifying antirheumatic drug therapy See the end of the ‘Possible side effects’ page for how to report side effects. You will normally need to have regular tests while you’re on filgotinib to make sure it isn’t having any unwanted effects on your blood, liver or general health. Please consult with doctor for medical advice. The authors discuss issues surrounding selectivity and efficacy Jul 23, 2019 · Abstract Importance: Patients with active rheumatoid arthritis (RA) despite treatment with biologic disease-modifying antirheumatic drug (bDMARD) therapy need treatment options. It includes information on how filgotinib works, how effective it is, dose, possible side effects and special precautions. Understanding these side effects can help in making informed decisions regarding treatment and Sep 9, 2024 · This Review provides an update on developments in Janus kinase inhibitors, including new disease indications and adverse effects. Reporting of side effects side effects, talk to your doctor or pharmacist. I've had the counselling and checked out the research. You can help by reporting any side effects you may get. Methods Eligible patients completing the 24-week DARWIN 1 (filgotinib + MTX) and DARWIN 2 (filgotinib Jul 18, 2025 · Jyseleca 100 mg film-coated tablets Active Ingredient: filgotinib maleate Company: Alfasigma UK Limited (formerly Galapagos Biotech Limited) See contact details Oct 13, 2023 · In conclusion, our results show that filgotinib and upadacitinib are ETA. Nov 4, 2021 · Hi BlodynhaulI'm about to start FILGOTINIB as part of a trial which will monitor side effects and benefits. This article covers its mechanism of action, indications, dosage, a thorough analysis of side effects including serious warnings, drug interactions, and safety information. com. 4 Filgotinib has a marketing authorisation for treating moderately to severely active ulcerative colitis when conventional or biological treatment cannot be tolerated, or if the disease has not responded well enough or stopped responding to treatment. Oct 6, 2023 · Filgotinib is an orally administered, preferential Janus kinase (JAK) inhibitor indicated for the treatment of moderate-to-severe rheumatoid arthritis (RA). Summary of medicine characteristics contains detail information about dosage for adults and children , composition and side effects of medicine Jyseleca The phase 2 MANTA and MANTA-RAy studies aimed to determine if the oral Janus kinase 1 preferential inhibitor filgotinib affects semen parameters and sex hormones in men with inflammatory diseases. Dec 17, 2021 · They do report more side effects on higher doses and their doctors do require lab tests at least every three months to check for high or low white or red blood cell counts, changes in cholesterol, and changes in liver and kidney function – all of which have been commonly reported. The adverse effects are classified according to their impact on various eye segments, such as the orbit, ocular surface, anterior segment, posterior Sep 9, 2024 · Filgotinib may reduce the risk of treatment failure and visual acuity loss for patients with various types of uveitis. The short-term safety, efficacy, and patient-reported outcomes (PROs) with filgotinib from Taking medicines and managing side effects can be difficult – we understand and we’re here to help. Following oral dosing, filgotinib is rapidly converted to its primary active metabolite, which has a similar Janus kinase 1 selectivity profile and contributes to the overall pharmacodynamic response. UK. The aim of this study was to assess the real-world effectiveness and safety of filgotinib in UC, while also identifying predictive factors associated with favourable treatment response. Tofacitinib, filgotinib and Side Effects[edit | edit source] Common side effects of Filgotinib include nausea, upper respiratory tract infection, and urinary tract infection. Our drug directory offers in-depth details on its uses, side effects, and more. Get all the details about Filgotinib from MedicinesFAQ. Clinical trials have demonstrated that filgotinib can significantly improve symptoms in psoriatic arthritis patients. Peficitinib is a pan-JAK inhibitor, meaning it targets multiple JAK enzymes. Mar 9, 2024 · When side effects were reported, we recommended the patients to discontinue IN. 7% vs 4. 5%, P = 0. However, a comparative analysis of these JAK inhibitors, particularly in patients previously treated with tofacitinib (TOF), has not been performed. This will allow quick identification of new safety information. These side effects include cardiovascular conditions, blood clots, cancer and serious infections. Serious side effects may include serious infections, cancers, and blood clots. Filgotinib vs upadacitinib in ulcerative colitis – which is better? Review by Prof. 0144) and day 7 in biologic-experienced patients (10. Do not pass it on to others. This retrospective, single-center study conducted at the Padua Hospital outpatient clinic compares the effectiveness and safety of these agents in patients with UC No drug-related side effects were recorded during follow-up and none of the patients discontinued the treatment. Results of this study may be pooled with the results of a separate study being conducted in participants with inflammatory bowel disease (Protocol GS-US-418-4279 Apr 26, 2023 · Background Janus kinase (JAK) inhibitors are a class of medicines that include Cibinqo (abrocitinib), Jyseleca (filgotinib), Olumiant (baricitinib), Rinvoq (upadacitinib), and Xeljanz (tofacitinib This randomized trial compares the effects of 2 doses of filgotinib vs placebo on the signs and symptoms of rheumatoid arthritis in a treatment-refractory population. Filgotinib has a low drug–drug interaction potential without clinically significant interactions with commonly coadministered medications, such as methotrexate or statins; cytochrome P450 3A4 Effects of filgotinib on semen parameters and sex hormones in male patients with inflammatory diseases: results from the phase 2, randomised, double-blind, placebo-controlled MANTA and MANTA-RAy studies Nov 13, 2024 · In this study filgotinib demonstrated similar clinical remission, clinical response and endoscopic improvement compared to tofacitinib in both biologic naïve and experienced UC patients. 168 patients were enrolled in the study; 98 patients received FIL and 70 UPA. The above information comes from the Internet. The PK of filgotinib and its major metabolite was dose proportional over the 30–300 mg range. Plain language summary Filgotinib is a treatment for patients with ulcerative colitis and rheumatoid arthritis, and is being studied in other inflammatory diseases. 2%, P = 0. The Janus kinase (JAK) inhibitor therapeutic class has shown significant clinical benefit in the treatment of rheumatoid arthritis (RA). Sep 10, 2017 · I tried filgotinib 3 years ago for 3 months. Frequently, side-effects of JAK inhibitors are mild-to-moderate, predictable, and easy to manage, yet dose modifications might be mandatory in some patients and patients need close monitoring. compared the treatment effects of four JAK inhibitors (Peficitinib, Filgotinib, Baracitinib, Upadacitinib) on PsA synovial fibroblasts and the results showed that Peficitinib has the most significant inhibitory effect, indicating that Peficitinib has a potential position in the treatment of PsA [33]. Filgotinib is absorbed extensively and rapidly after oral dosing and is What are Janus kinase inhibitors? Janus kinase (JAK) inhibitors, also called jakinibs or JAKis, are small molecules that interrupt the JAK-STAT (Signal Transducer and Activator of Transcription) signalling pathways involved in the pathogenesis of many immune-mediated inflammatory diseases (IMIDs). Safety results showed a proven long-term benefit-risk profile. 6. The position of filgotinib in therapeutic pathways and the ideal sequence of medications May 5, 2021 · Filgotinib’s effects also appear to be dose dependent. It is already approved for the treatment of rheumatoid arthritis and is being evaluated for the management of patients with moderate to severe ulcerative colitis [UC]. However, a comparative analysis of these JAK inhibitors, particularly in patients previously treated with Dec 8, 2023 · In the Edinburgh IBD Unit, filgotinib started to be used from July 2022, with a significant number of UC patients receiving it as a first-line treatment. This means that despite the benefit shown for the treatment of RA and AS, Filgotinib will not be available until the middle of Apr 22, 2025 · The selectivity of filgotinib for JAK1 aims to mitigate the risk of side effects commonly linked to broader JAK inhibition, including infections and blood disorders. The phase 2 MANTA and MANTA-RAy studies were developed in consultation with global regulatory authorities to investigate potential impacts of filgotinib, a Janus kinase 1 preferential inhibitor, on semen parameters in men with active inflammatory Nov 16, 2021 · Filgotinib is a small molecule that selectively inhibits Janus kinase [JAK] type 1. Specific warnings and information material are available to help manage these risks. [3] Filgotinib was approved for medical use in both the European Union and Japan in September 2020. Apr 15, 2021 · In the case of filgotinib, some hypothesized that its ability to maintain preferential JAK1 inhibition over JAK2 at high doses may underly its dose-dependent incremental efficacy in the absence of dose-limiting side effects; nevertheless, further study would be needed to provide definitive mechanistic support for this notion. Used as immunosuppressants. 4 days ago · Effect of other medicinal products on filgotinib: Filgotinib is primarily metabolised by carboxylesterase 2 (CES2), which can be inhibited in vitro by medicinal products such as fenofibrate, carvedilol, diltiazem or simvastatin. Nov 27, 2024 · Background: Janus kinase inhibitors (JAKis) are a novel class of drugs interfering with intracellular signaling of type I and type II cytokines, which play a crucial role in immune dysregulation associated with several chronic inflammatory diseases. Jun 10, 2025 · In general, the side effects of Jyseleca were similar to those of other medicines of its class, and the most important side effect is infection. Know about technical details of Filgotinib pound GLPG0643) like: chemical name, chemistry structure, formulation, uses, toxicity, action, side effects and more at Pharmacompass. You can also report side effects directly via the Yellow Know about technical details of Filgotinib like: chemical name, chemistry structure, formulation, uses, toxicity, action, side effects and more at Pharmacompass. Filgotinib is an orally administered, preferential Janus kinase (JAK) inhibitor indicated for the treatment of moderate-to-severe rheumatoid arthritis (RA). Effect of other medicinal products on filgotinib: Filgotinib is primarily metabolised by carboxylesterase 2 (CES2), which can be inhibited in vitro by medicinal products such as fenofibrate, carvedilol, diltiazem or simvastatin. Clinical relapse was defined as the addition of a new therapeutic agent or an increase in pMayo score of ≥ 3. Get the latest medication information and prescription drug insights today! Exploring the selective JAK1 inhibitor mechanism of action: Filgotinib Maleate targets JAK1 to effectively disrupt pro-inflammatory cytokine signaling pathways. Abstract Background: Janus kinase (JAK) inhibitors, filgotinib (FIL) and upadacitinib (UPA) have emerged as promising treatments for ulcerative colitis (UC). Filgotinib was firstly approved for the treatment of RA by EU and Japan in September 2020, and later it was approved by EU for the treatment of UC in May 7, 2025 · Psychological side effects such as anxiety, low mood, sleep disturbance, poor concentration, and forgetfulness have been infrequently reported in people with cystic fibrosis treated with Kaftrio May 13, 2023 · Hope your back pain gets sorted out - just another thing to put up with - and whatever side effects you’re still having from Filgotinib subside and it works well for you in the coming months. 0155) (Figure 1 e, f). The most common side effects include nausea (feeling sick), upper respiratory tract infection (nose and throat infection), urinary tract infection and dizziness. Janus kinase (JAK) inhibitors, filgotinib (FIL) and upadacitinib (UPA) have emerged as promising treatments for ulcerative colitis (UC). The most common side effects are nausea, upper respiratory tract infection, urinary tract infection and dizziness. Indication: Filgotinib is a prescription medicine used to treat adults with moderate to severe active rheumatoid arthritis, especially in patients who haven't responded well to or cannot tolerate traditional disease-modifying antirheumatic drugs (DMARDs), like methotrexate. market but is sold across Europe, Great Britain, and Japan, remained effective for 3 years for most registration 4 days ago · Key Points Approved RA Medications: Tofacitinib (Xeljanz), Baricitinib (Olumiant), Upadacitinib (Rinvoq), and Filgotinib (Jyseleca) are the primary Janus kinase inhibitors used for rheumatoid arthritis,. Notably, GS-829845, the main metabolite of filgotinib, also showes selective inhibitory effect to JAK1 [22]. Effect of filgotinib on other medicinal products: Filgotin is not a clinically relevant inhibitor or inducer of Jan 22, 2025 · Filgotinib is a preferential JAK1-inhibitor approved for the treatment of ulcerative colitis (UC). DMARDs are medicines, such as methotrexate, that slow down the worsening of the disease. The purpose of this review is to provide an overview of the currently available data on filgotinib and to define how to position this new drug Sep 1, 2023 · In addition, O'Brien et al. Early side effects seen with other less selective JAK inhibitors were not observed (e. The most common side effects of these medications include minor infections as well as nausea, headache, and occasional diarrhea. The ICC registry was developed to evaluate the effectiveness and safety of advanced therapies in inflammatory bowel disease (IBD). 12). This article discusses its eficacy, side-effects and place in therapy. Methods: The effect of Filgotinib induced and maintained symptomatic remission and improved HRQoL over 4 years. November 2022. This includes any possible side effects not listed in this leaflet. The FDA requested additional data from the safety trials in assessing the effect of the 200 mg dose of Filgotinib on sperm concentration. This includes any possible side effects not listed in the package leaflet. EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders . Nov 17, 2022 · Filgotinib is also approved as monotherapy. We reviewed our patients treated with filgotinib following the additional measures recommended by the EMA to identify those at increased risk of side effects with JAK inhibitors. Please use this to tell us if you have had any flares, needed any courses of steroids or experienced any side effects related to the medicine. Like biologic drugs, these are ‘targeted’ therapies, but in tablet form. What are Janus kinase inhibitors used for? Janus kinase inhibitors have shown beneficial effects Both filgotinib and its primary metabolite contribute to the overall clinical efficacy of the molecule; therefore, in instances where intrinsic/extrinsic factors show some effect on filgotinib or metabolite pharmacokinetics, both parent and metabolite exposures can be combined into a single parameter, AUC eff (the sum of the AUC of fil-gotinib Jun 19, 2021 · Filgotinib 200 mg was well tolerated, and efficacious in inducing and maintaining clinical remission compared with placebo in patients with moderately to severely active ulcerative colitis. We sought to gain insight into the mode of action and immunological effects of filgotinib, a JAK1 selective Nov 11, 2022 · EMA’s human medicines committee (CHMP) has endorsed the measures recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) to minimise the risk of serious side effects with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders. Sep 22, 2025 · Learn about the side effects of brigatinib, from common to rare, for consumers and healthcare professionals. Sep 1, 2024 · Objective: To assess the efficacy and safety of filgotinib, a Janus kinase 1 (JAK1) preferential inhibitor, for the treatment of noninfectious uveitis. Preferential inhibition of JAK1 modulates a subset of proinflammatory cytokines within the JAK–signal transducer and activator of transcription pathway, which differ from those inhibited by JAK2 or JAK3. S. The rationale for the difference could be hypothesized by filgotinib having a minimal blockade of JAK2; in contrast, upadacitinib has a weak blockade effect. Zero effect. Jan 7, 2025 · Learn about Filgotinib uses, dosage, side effects, food interactions, and more. Filgotinib works to block the effects of JAKs and reduce inflammation. Approximately 476 participants 18 years of age or older will participate across 20 countries globally and will receive the study drug daily as tablets to be swallowed. gov][1]: [NCT02065700][2]). We aimed to compare safety profiles between FIL and UPA. Apr 30, 2024 · The primary objective of this study is to evaluate the effect of filgotinib on semen parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis. JAK inhibitors are the newest class of drugs used to treat RA. org Filgotinib (Jyseleca®), an oral Janus kinase (JAK) inhibitor, is approved as monotherapy or in combination with methotrexate to treat moderate to severe active rheumatoid arthritis (RA) in adults who have an inadequate response or intolerance to one Introduction Filgotinib was licensed for use in ulcerative colitis in the UK in January 2022 and NICE approved in June 2022. Haematologic effects In FINCH 1, 2, and 3 in patients with rheumatoid arthritis, treatment with filgotinib was associated with a small, transient increase in mean ALC that remained within normal reference ranges and gradually returned to at or near baseline levels with continued treatment by week 12. In the overall RA population the safety profile of 200mg filgotinib is not that different from 100mg. In-Depth Analysis of Filgotinib Side Effects The side effect profile of Jyseleca is a direct result of its intended immunosuppressive mechanism. Sep 14, 2020 · Filgotinib was presented to the FDA for approval for the treatment of RA. Filgotinib: Belongs to the class of Janus-associated kinase (JAK) inhibitors. Baricitinib and upadacitinib are also ETA due to a lack of clear differences and for showing superiority over placebo. When will it be available? When NICE recommends a treatment option, it should be available on the NHS within 3 months. This is because the drug works by modulating the immune system, which can impair the body’s ability to fight off infections. Read all of this website carefully before you start taking this medicine because it contains important information for you. Page 1 of 2 Monitoring of Filgotinib (Jyseleca®) Therapy for Inflammatory Bowel Disease What will happen? Your results will be reviewed by the team in the hospital. No deaths were reported. In this study filgotinib demonstrated similar clinical remission, clinical response and endoscopic improvement compared to tofacitinib in both biologic naïve and experienced UC patients. This article discusses its efficacy, side-effects and place in therapy. Filgotinib (FIL), in particular, is the newest member of the JAKi class and exerts its therapeutic effects by selectively targeting and inhibiting the kinase activity of JAK1. It is important to remember that these are only possible side effects. As with any medication, its use can be associated with a variety of side effects that patients and healthcare providers should be aware of. This integrated analysis of filgotinib clinical trials in rheumatoid arthritis (RA) and ulcerative colitis (UC) assessed adverse events of interest (AEI): major adverse cardiovascular events (MACE), venous thromboembolism (VTE) and malignancies. Filgotinib is absorbed extensively and rapidly after oral dosing and is As with any medicines, JAK inhibitors can cause side effects.