The Food and Drug Administration (FDA), USA, European Medical Agency (EMA), European Union, and Therapeutic Goods Administration (TGA), Australia, approvals of Taltz (ixekizumab) for plaque psoriasis were based on 3 double-blind trials that tested Taltz (ixekizumab) against placebo and an active comparator (UNCOVER-1,2,3). These studies involved a total of 3,866 patients with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy2,3,4.
The major efficacy outcome measures were the static Physician Global Assessment (sPGA) and the Psoriasis Area and Severity Index (PASI)2,4.
The sPGA is a measure of the status of the psoriatic lesions of a patient (i.e. plaque thickness/induration, erythema, scaling) on a severity scale from 0 (=clear) to 5 (=severe)5. The PASI additionally to the severity of the lesions takes into account the body surface area covered with psoriatic lesions7.
The results presented here are the average across the 3 studies, the complete results can be found in our resources section2,4. After 12 weeks Taltz (ixekizumab) administered every 2 weeks resulted as superior in all the measured parameters to all other tested conditions.
The sPGA after 12 weeks was:
- sPGA =0 (=clear) or 1 (=almost clear) in 81.8% of patients treated with Taltz (ixekizumab) every 2 weeks4
- sPGA =1 in 39.7% of the patients4
- sPGA =0 or 1 in
- 74.9% of the patients treated with Taltz (ixekizumab) every 4 weeks
- 38.8% of those treated with etanercept
- 4.1 % in the placebo cohort4.
The PASI after 12 weeks was:
- reduced by 100% in 37.8% of patients treated with Taltz (ixekizumab)every 2 weeks4
- reduced by 75% in4:
- almost 89% of those treated every 2 weeks with Taltz (ixekizumab)
- 82.5% of the patients on Taltz (ixekizumab) every 4 weeks
- 47.5% of patients on etanercept
- 4.5% of those given placebo.
To evaluate the maintenance and durability of the response, two studies continued for an additional 48 weeks in patients who at week 12 had responded to Taltz (ixekizumab) (both those on the biweekly plan and those on the monthly plan). These patients were randomly assigned to a maintenance dosage of Taltz (ixekizumab) every 4 weeks or to placebo. The best results were obtained in patients who took Taltz (ixekizumab) every 2 weeks for the first 12 weeks and every 4 weeks for the following 48 weeks. In this cohort, 78.3% of the patients maintained a sPGA of 0 or 1, and about 58% of these had maintained or achieved clear skin (sPGA = 0 in 58.8% and 100% reduction in PASI in 57.5%). On the other hand, only about 7% of the initial responders that switched to placebo had a sPGA of 0 or 14, meaning that most of them relapsed after interruption of the treatment with Taltz (ixekizumab).
The Food and Drug Administration (FDA), USA, and European Medical Agency (EMA), European Union, approvals of Taltz (ixekizumab) for psoriatic arthritis were based on 2 placebo-controlled studies (SPIRIT-P1/PsA1 and SPIRIT -P2/PsA2). These studies involved a total of 780 patients with active psoriatic arthritis2,4.
The major efficacy outcomes were the ACR 20, 50 and 70. In both studies, patients treated with Taltz (ixekizumab) 80 mg demonstrated a greater clinical response compared to placebo at Week 242,4.
An important measure in patients with rheumatoid arthritis is the ACR 20, 50 or 70 which is a criteria to measure the improvement of patients of 20%, 50% or 70% based on measures as swollen joint count, tender joint count, patient assessment of global status, acute phase reactant (dramatic increase in hepatic synthesis of plasma proteins which accompanies acute phases of tissue injury and inflammation), health professional assessment of global status, physical function, and pain9.
The ACR20 response at week 24 was2,4:
The ACR50 response at week 24 was2,4:
The ACR70 response at week 24 was2,4: