TALTZ Rx

Psoriatic Arthritis

• The safety and efficacy of Taltz was evaluated in 679 patients in 2 randomized, double-blind, placebo-controlled studies (PsA1 and PsA2) in adults, age 18 years and older with active psoriatic arthritis (at least 3 swollen and at least 3 tender joints) despite non-steroidal anti-inflammatory drug (NSAID), corticosteroid or disease modifying anti-rheumatic drug (DMARD) therapy. 

• The PsA1 Study (NCT01695239) included 417 biologic-naive patients, who were treated with either Taltz 160 mg at Week 0 followed by 80 mg every 2 weeks (Q2W) or 4 weeks (Q4W), adalimumab 40 mg every 2 weeks, or placebo. The PsA2 Study (NCT02349295) included 363 anti-TNFα experienced patients, who were treated with Taltz 160 mg at Week 0 followed by 80 mg every 2 or 4 weeks, or placebo. Patients receiving placebo were re-randomized to receive Taltz (80 mg every 2 or 4 weeks) at Week 16 or Week 24 based on responder status.

• The primary endpoint was the percentage of patients achieving an ACR20 response at week 24.

• In PsA1, patients treated with Taltz 80 mg every 4 weeks achieved the following clinical responses compared with placebo , respectively:

• ACR20 response 

• Week 12: 57% vs 31% (difference from placebo, 26% [95% CI, 13-39])

• Week 24: 58% vs 30% (difference from placebo, 28% [95% CI, 15-41])

• ACR50 response 

• Week 12: 34% vs 5% (difference from placebo, 29% [95% CI, 19-39])

• Week 24: 40% vs 15% (difference from placebo, 25% [95% CI, 14-37])

• ACR70 response 

• Week 12: 15% vs 0% (difference from placebo, 29% [95% CI, 19-39])

• Week 24: 23% vs 6% (difference from placebo, 18% [95% CI, 9-27])

• In PsA2, patients treated with Taltz 80 mg every 4 weeks achieved the following clinical responses compared with placebo , respectively:

• ACR20 response 

• Week 12: 50% vs 2% (difference from placebo, 28% [95% CI, 16-40])

• Week 24: 53% vs 20% (difference from placebo, 34% [95% CI, 22-45])

• ACR50 response 

• Week 12: 31% vs 3% (difference from placebo, 28% [95% CI, 19-37])

• Week 24: 35% vs 5% (difference from placebo, 30% [95% CI, 21-40])

• ACR70 response 

• Week 12: 15% vs 2% (difference from placebo, 13% [95% CI, 6-20])

• Week 24: 22% vs 0% (difference from placebo, 22% [95% CI, 15-30])

• For patients with pre-existing dactylitis or enthesitis, treatment with Taltz resulted in improvement in dactylitis and enthesitis.

• For patients with PsA, treatment with Taltz 80mg every 4 weeks achieved improvement in psoriatic skin lesions.

• Additionally, in PsA1, treatment with Taltz inhibited the progression of structural joint damage at week 16 compared with placebo. Both studies showed that treatment with Taltz achieved improvement in physical function compared with placebo as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI) at week 12 and 24.

Psoriatic Arthritis

• The safety and efficacy of Taltz were assessed in 567 patients, in 2 randomized, double-blind, placebo-controlled studies (AS1 and AS2) in adult patients, age 18 years and older with active ankylosing spondylitis. Patients had active disease as defined by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 despite non-steroidal anti-inflammatory drug (NSAID), corticosteroid, or disease modifying anti-rheumatic drug (DMARD) therapy.

• AS1 Study (NCT02696785) included 341 biologic-naive patients who received either Taltz 80 mg or 160 mg at Week 0 followed by 80 mg every 2 weeks (Q2W) or 4 weeks (Q4W), adalimumab 40 mg every 2 weeks, or with placebo. Patients receiving placebo were re-randomized at Week 16 to receive Taltz (160 mg starting dose, followed by 80 mg Q2W or Q4W). Patients receiving adalimumab were re-randomized at Week 16 to receive Taltz (80 mg Q2W o rQ4W).

• AS2 Study (NCT02696798) included 316 TNF-inhibitor experienced patients (90% were inadequate responders and 10% were intolerant to TNF inhibitors). All patients were treated with Taltz 80 or 160 mg at Week 0 followed by 80 mg Q2W or Q4W, or with placebo. Patients receiving placebo were re-randomized at Week 16 to receive Taltz (160 mg initial dose, followed by 80 mg Q2W or Q4W). 

• The primary endpoint in both studies was the percentage of patients achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) response at Week 16.

• In both studies, patients treated with Taltz 80 mg every 4 weeks achieved greater improvements in ASAS40 and ASAS20 responses at week 16 compared with placebo, respectively:

• ASAS20 response 

• AS1: 64% vs 40% (difference from placebo, 24% [95% CI, 9-39])

• AS2: 48% vs 30% (difference from placebo, 18% [95% CI, 6-31])

• ASAS40 response 

• AS1: 48% vs 18% (difference from placebo, 30% [95% CI, 16-43])

• AS2: 25% vs 13% (difference from placebo, 13% [95% CI, 3-23])

• For patients with pre-existing dactylitis or enthesitis, treatment with Taltz resulted in improvement in dactylitis and enthesitis.

• For patients with PsA, treatment with Taltz 80mg every 4 weeks achieved improvement in psoriatic skin lesions.

• Additionally, in PsA1, treatment with Taltz inhibited the progression of structural joint damage at week 16 compared with placebo. Both studies showed that treatment with Taltz achieved improvement in physical function compared with placebo as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI) at week 12 and 24.

• In both studies, treatment with Taltz improved the main components of the ASAS40 response criteria and other measures of disease activity at week 16, including BASFI, BASDAI score, BASMI, and high sensitivity C-reactive protein (hsCRP). 

Non-radiographic Axial Spondyloarthritis

• The efficacy and safety of Taltz were assessed in a randomized, double-blind, 52-week placebo-controlled study (nr-axSpA1) (NCT02757352) in patients ≥18 years of age with active axial spondyloarthritis for at least 3 months. Patients were required to be intolerant to or had an inadequate response to at least 2 NSAIDs.

• Patients were randomly assigned to receive either placebo or Taltz 80 mg or 160 mg at Week 0, followed by either 80 mg every 2 weeks or 80 mg every 4 weeks. The primary endpoint was the percentage of patients achieving an Assessment of Spondyloarthritis International Society (ASAS40) response at week 52. The ASAS40 response was also evaluated at week 16 as a major secondary endpoint.

• At week 52, 30.2% of patients treated with Taltz 80 mg every 4 weeks achieved ASAS40 response compared with 13.3% of those treated with placebo (difference from placebo, 16.9% [95% CI, 5.6-28.1]).

• At week 16, 35.4% of patients treated with Taltz 80 mg every 4 weeks achieved ASAS40 response compared with 19% of those treated with placebo (difference from placebo, 16.4% [95% CI, 4.2-28.5]).

• In both studies, treatment with Taltz improved the main components of the ASAS40 response criteria and other measures of disease activity at week 16, including BASFI, BASDAI score, BASMI, and high sensitivity C-reactive protein (hsCRP). 

Adult Plaque Psoriasis

• Efficacy was evaluated in 3 multicenter, randomized, double-blind, placebo-controlled trials Trials 1, 2, and 3 (NCT01474512, NCT01597245, NCT01646177), which enrolled a total of 3866 subjects 18 years of age and older with plaque psoriasis who had a minimum BSA involvement of 10%, a static Physician Global Assessment (sPGA) score of ≥3 in the overall assessment (plaque thickness/induration, erythema, and scaling) of psoriasis on a severity scale of 0 to 5, a Psoriasis Area and Severity Index (PASI) score ≥12, and who were candidates for phototherapy or systemic therapy. 

• In all 3 trials, patients were randomly assigned to placebo or Taltz 80mg every 2 weeks for 12 weeks following a 160mg starting dose. In active comparator Trials 2 and 3, patients also received etanercept 50mg twice weekly for 12 weeks.

• The 2 coprimary endpoints were: 1) PASI 75, the proportion of subjects who achieved at least a 75% reduction in the PASI composite score that takes into consideration both the percentage of body surface area affected and the nature and severity of psoriatic changes (induration, erythema and scaling) within the affected regions, and 2) sPGA of “0” (clear) or “1” (minimal), the proportion of subjects with an sPGA 0 or 1 and at least a 2-point improvement.

• At week 12, patients treated with Taltz achieved the following results vs those treated with placebo, respectively:

• sPGA of “0” or “1”: [Trial 1] 82% vs 3%; [Trial 2] 83% vs 2%; [Trial 3] 81% vs 7%

• sPGA of “0”: [Trial 1] 37% vs 0%; [Trial 2] 42% vs 1%; [Trial 3] 40% vs 0%

• PASI 75: [Trial 1] 89% vs 4%; [Trial 2] 90% vs 2%; [Trial 3] 87% vs 7%

• PASI 90: [Trial 1] 71% vs 1%; [Trial 2] 71% vs 1%; [Trial 3] 68% vs 3%

• PASI 100: [Trial 1] 35% vs 0%; [Trial 2] 40% vs 1%; [Trial 3] 38% vs 0%

• Itch NRS (≥4 point improvement): [Trial 1] 86% vs 16%; [Trial 2] 85% vs 14%; [Trial 3] 83% vs 21%

Pediatric Plaque Psoriasis

• The randomized, double-blind, multicenter, placebo-controlled trial (IXORA-Peds, NCT03073200) included 171 pediatric subjects 6 to <18 years of age, with moderate-to-severe plaque psoriasis (as defined by a sPGA score ≥3, involving ≥10% of the BSA, and a PASI score ≥12) who were candidates for phototherapy or systemic therapy or were inadequately controlled on topical therapy. 

• Patients were randomly assigned to receive placebo or Taltz with dosing stratified by weight:

• <25kg: 40mg at Week 0 followed by 20mg every 4 weeks

• 25kg–50kg: 80mg at Week 0 followed by 40mg every 4 weeks

• >50kg: 160mg at week 0 followed by 80mg every 4 weeks

• The coprimary endpoints were the proportion of patients who achieved an sPGA score of “0” (clear) or “1” (almost clear) with at least a 2-point improvement from baseline and the proportion of subjects that achieved a reduction in PASI score of at least 75% (PASI 75) from baseline. Response to treatment was assessed at 12 weeks of therapy. 

• At week 12, patients treated with Taltz achieved the following clinical responses compared with those treated with placebo:

• sPGA “0” or “1”: 81% vs 11%

• sPGA “0”: 52% vs 2%

• PASI 75: 89% vs 25%

• PASI 90: 78% vs 5%

• PASI 100: 50% vs 2%

• Itch NRS (≥4 point improvement): 71% vs 20%

• At week 4, patients treated with Taltz achieved the following clinical responses compared with those treated with placebo:

• sPGA “0” or “1”: 48% vs 7%

• PASI 75: 54% vs 9%