Shots: The approval is based on P-lll COAST-X study assessing Taltz (80mg, q4w) vs PBO for the treatment of adult patients with nr-axSpA with objective signs of inflammation for 52wks. Result: 1EPs of ASAS40 @16wks. (35% vs 19%); ASAS40 response @52wks. (30% vs 13%), met its 2EPs, showing efficacy in reducing disease activity and sacroiliac […]Read More
Shots: Eli Lilly shared new results from a subgroup analysis of the P-IIIb/IV, 52-wks. SPIRIT-H2H study assessing Taltz vs Humira (adalimumab) in biologic-naïve patients with active PsA with 1EPs as ACR50 & PASI 100 @24wks. The study compares Taltz and Humira in subgroups of patients on monothx./ concomitant MTX/ concomitant MTX along with csDMARD including […]Read More
Shots: The approval is based on P-III study assessing Taltz (20mg for <25kg/40mg for 25-50kg/80 mg for >50 kg @12wks., with 40/80/160mg starting doses, respectively) vs PBO in 171 patients aged 6-18 yrs. with mod. to sev. PsO who are candidates for systemic therapy or phototherapy The P-III study results: patients achieving PASI 75 (89% […]Read More
Shots: The approval follows two P-III studies (COAST V & COAST W) assessing Taltz (q4w) vs PBO in 657 patients with active AS who are bDMARD-naïve & intolerant to TNF inhibitors respectively The P-III studies result: improvement in 1EPs i.e. achievement of ASAS40 @16wks. (48% & 25% vs 18% & 13%); improvement in 2EPs (64% […]Read More
Shots: The P-IV IXORA-R study involves assessing of Taltz vs Tremfya (guselkumab) in 1,027 patients with moderate to severe plaque psoriasis for a total of 24 wks., with the primary analysis conducted at 12 wks. The P-IV IXORA-R study results: met its 1EPs & 2EPs i.e, complete skin clearance as measured by PASI 100 @12wks. […]Read More
Shots: The approval is based on two P-III studies assessing Taltz vs PBO in 657 patients with active AS, randomized into two groups i.e, COAST-V in patients who are bDMARD-naïve and COAST-W in patients who are intolerant or have an inadequate response to TNF inhibitors The two P-III study results: patients achieved ASAS40 @16wks. COAST-V […]Read More
Shots: The P-IV IXORA-R study involves assessing of Taltz (160 mg at wk 0, followed by 80 mg at wks. 2, 4, 6, 8, 10, and 12, then 80 mg, q4w) vs Tremfya (SC, 100 mg) in 1,027 patients with moderate to severe plaque psoriasis evaluating efficacy, safety for 24 wks. The study met 1EPs […]Read More
Shots: The P-IIIb/IV SPIRIT-H2H study results involve assessing of Taltz vs Humira (adalimumab) in 566 patients with PsA who are biologic DMARD-naive for 52wks. The P-IIIb/IV SPIRIT-H2H study results: met its 1EPs & 2Eps i.e, @24wks. reduction by 50% in disease activity as defined by ACR50; PASI100 (36% vs 28%) & superior to Humira, ACR50 […]Read More
Shots: The P-III study results involves assessing of Taltz in patients with moderate to severe plaque psoriasis for 5yrs.in addition to an extension study UNCOVER-1 Collective results: 90%+ maintained skin clearance as measured by PASI 75; @264wks. PASI 75 (94.3); PASI 90 (81.8%); PASI 100 (46.6%), presented at WCD with additional data of UNCOVER-3 study […]Read More
Shots: The P-III COAST-X study involves assessing of Taltz (ixekizumab) vs PBO in patients with non-radiographic axial spondyloarthritis (nr-axSpA) who are biologic disease-modifying anti-rheumatic drug (bDMARD) naive for 52wks. The P-III COAST-X study results: @16 & 52wks. met its 1Eps & 2Eps; improvement in the signs and symptoms of nr-axSpA; improvement in ASDAS & BASDAI; […]Read More
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