New rheumatoid arthritis (RA) new drug! Gilead oral JAK1 inhibitor filgotinib treatment for 52 weeks shows long-lasting efficacy and consistent safety!

, 2020 /

BIOON/Biovalley/ Gilead Sciences and partner Galapagos NV recently announced the 52-week results of the oral selective JAK1 inhibitor filgotinib for moderate to severerheumatoid arthritis(RA) adult patients FINCH 1 and FINCH 3The data show edilateinib has sustained efficacy and consistent safety during the 52-week period of treatment in the RA patient populationThese data add to the evidence that filgotinib is used as a potential treatment option for a range of RA patientsFINCH 1 study: 52 weeks data in RA patients with inadequate response to methotrexate (MTX):The FINCH 1 study was conducted in patients with moderate to severe active RA with insufficient methotrexate response (MTX-IR) and evaluated the efficacy and safety of filgotinib, placebo, adamu monotomoine and stable background dose methotrexateIn the study, patients were randomly grouped to receive a daily dose of 200 mg filgotinib (n-475), a daily dose of 100 mg filgotinib (n-480), a 40 mg dose of Adamu monotoma (n-325), and a placebo (n?475)as mentioned earlier, the filgotinib 200mg group reached the primary endpoint: at the 12th week, a higher proportion of patients in the filgotinib 200mg group reached the ACR20 response than the placebo groupFilgotinib outperformed placebo in all secondary endpoints associated with symptoms of RA, physiological function and structural impairmentmost patients in the FINCH 1 study (80.7%, n-1417/1755) completed 52 weeks of treatment with the drugAt week 52, two doses of filgotinib showed continuous efficacy in both primary and secondary efficacy assessmentsIn addition, at week 52, a higher proportion of patients in the 200mg filgotinib group achieved low disease activity (DAS28 (CRP) 3.2) and clinical remission (DAS28 (CRP)2.6) (nominal p 0.05)Based on the CDAI-2.8 and Boolean mitigation criteria, the 200mg filgotinib group mitigation rate was also significantly higher in week 52 than in the Adamu mono-antigroup (nominal p 0.05)From the baseline check to the 52nd week, the 200mg filgotinib group decreased significantly more than the Health Assessment Questionnaire-Disability Index Scale (HAQDI) score compared to the Adamu monoanti-resistance group (nominal p 0.05)At these ends, the response rate of the 100mg filgotinib group and the Adamu monoantidgroup group is numerically similar in the MTX-IR patient study, 200mg and 100mg filgotinib showed consistent safety and no new safety signals were detected during the 52-week period FINCH 3 study: 52 weeks data in patients who were not treated with methotrexate (MTX) RA: THE FINCH 3 STUDY WAS CONDUCTED IN PATIENTS WITH MODERATE TO SEVERE ACTIVE RA IN THE INITIAL TREATMENT OF METHOTREXATE In the study, patients were randomly grouped to receive a daily dose of 200 mg filgotinib and MTX (n?416), a daily dose of 100 mg filgotinib-MTX (n-207), and a daily dose of 200 mg of filgotinib monodrug therapy (n-210), and MTX single-drug therapy (n?416) as mentioned earlier, the 200mg filgotinib-MTX group reached the main endpoint: a higher proportion of patients in the 200mg filgotinib-MTX group reached ACR20 mitigation (p.001) compared to the MTX single drug group Most patients in the FINCH 3 study (80.7%, 78.1%, n-975/1249) completed the 52-week treatment of the drug In this analysis, all treatment groups showed sustained efficacy over a 52-week period, based on clinical response, physical function and imaging progress In the 52nd week of treatment, the proportion of patients in the 200mg filgotinib-MTX group, 100mg filgotinib-MTX group, and the 200mg filgotinib single drug group reached a higher percentage of ACR20 response (nominal p 0.001, p 0.01, p.01) ACR50 Response (nominal p 0.001, p 0.01, p 0.01), ACR70 answer (nominal p 0.001, p 0.05, p 0.01), disease remission (nominal p 0.001 for all three groups of patients) At the 52st week, the physical function of patients in the 200mg filgotinib-MTX group (nominal p 0.001) or 200mg filgotinib single drug group (nominal p 0.05) improved significantly compared to the MTX single drug group (measured by the reduction of baseline levels by HAQDI score) in week 52, there was less progress in structural impairment in patients in the 200mg filgotinib-MTX group (nominal p 0.001), 100mg filgotinib-MTX group (nominal p 0.05), and 200mg filgotinib single drug group (nominal p 0.05) the study, filgotinib combined with MTX or monopharmaceutical therapy showed consistent safety in adult patients with RA who had not previously received MTX (MTX primary treatment) and found no new safety signals FINCH 2 study: Subgroup Analysis Data in RA Patients With Inadequate Response to Anti-Rheumatoid Drugs (bDMARD-IR) for Biological Disease sadct: Although treatments are currently available, many RA patients do not respond adequately to bDMARD In patients with bDMARD-IR, subgroup analysis at the 24th week of treatment showed a high rate of low disease activity and remission compared to placebo, regardless of the amount of bDMARD previously received and whether iEl-6 or TNF inhibitors had previously been received The difference in the proportion of patients with low disease activity in the 200 mg filgotinib group was statistically significant compared to the placebo group (p.001) adverse events in subgroups were consistent with the entire study population Comprehensive safety analysis of the PHASE III FINCH and PHASE II DARWIN PROJECTs: a comprehensive safety analysis of filgotinib in seven clinical trial
s in the FINCH III and DARWIN II projects, and the data reinforced the consistent safety of filgotinib treatment RA, without any new safety issues In these trials, 3,827 RA patients received more than one dose of treatment, with a total exposure time of 4544.5 years patients treated with filgotinib, the incidence of severe adverse events (SAE) or adverse events (TRAE) exposure correction during treatment (EAIR) comparable to EAIR in patients treated with placebo, adamizumab, mTX; filgotinib severely infected and shingles EAIR is similar to Adamum monotoma and MTX The shingles are mostly light and moderate, not serious Filgotinib had lower numerical frequencies of major adverse cardiovascular events (MACE) and venous thromboembolism (VTE) than placebos In this comprehensive analysis, filgotinib was well tolerated and no new safety issues were found filgotinib molecular structure (Photo: Wikipedia) filgotinib is a highly selective JAK1 inhibitor, discovered and developed by Galapagos Gilead reached a $2 billion deal with Galapagos at the end of December 2015 to jointly develop filgotinib The partnership will help strengthen Gilead's position in the inflammatory disease sector, which will also be a new growth point for Gilead in the future, following the areas of hepatitis C and HIV December 2019, Gilead The FDA submitted a new application for a new drug for filgotinib treatment rheumatoid arthritis (RA) It is worth mentioning that Gilead also submitted a priority review voucher to shorten the review time Currently, filgotinib's treatment for RA indications is also under review by EU and Japanese regulators In addition to RA, both sides are also developing the drug for a variety of other inflammatory diseases, the treatment of Crohn's disease, ulcerative colitis has entered Phase III studies pharmaceutical market research firm Evaluate Pharma had predicted that filgotinib will be one of Gield's key products for future growth, with global sales expected to reach $1.4 billion by 2024 However, in the field of JAK inhibitors, filgotinib will also face a number of competing products, in addition to the two listed products
Pfizer
Xeljanz and Lilly Olumiant, the stronger competitor will be AbbVie's Rinvoq, which has been approved in the U.S and Europe for moderate to severe RA Evaluate Pharma also previously forecast sales of $2.57 billion in 2024 after Rinvoq goes public (BioValleyBioon.com) original source: Filgotinib SP Ford Inthebdo and Safety Profile at 52 Weeks in FINCH 1 and 3 Studies in Rheumatoid Arthritis