Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CHS-0214 · 3 trials · 2 indications
The ACR20 is a composite endpoint based on the following assessments: 66/68 swollen joint count (SJC) or tender joint count (TJC), Subject's pain assessment (SPA)-visual analog scale (VAS),Subject's global assessment of disease activity (SGA)-VAS,Physician's global assessment of disease activity (PGA)-VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and High sensitivity C-reactive protein (hs-CRP).The baseline value to assess the ACR20 during this study was the same baseline value used to assess the ACR20 during the parent study (ie, the Week 0 assessment in the parent study). Subjects were considered an ACR20 responder at a visit if compared to baseline in the parent study (CHS-0214-02) they achieved: At least 20% decrease in SJC, At least 20% decrease in TJC, and At least 20% improvement in at least 3 of the following 5 measures: C-reactive protein, HAQ-DI, SPA (using a VAS) for pain,SGA (using a VAS), orPGA (using a VAS).
All PASI score assessors must have demonstrated proficiency at performing the PASI. Every attempt was made to use the same assessor for each subject throughout the study. n subjects with PsO, durability of response (maintenance of a PASI-50 response or greater at each assessment) was based on scoring the PsO lesions on a scale of 0 to 4 for 3 characteristics: erythema, induration, and desquamation, and within 4 anatomical regions: head, trunk, upper extremities, and lower extremities. Within each of these regions, the area of involvement was scored on a scale of 0 to 6, with the total score being a weighted average, and weights defined by the area of involvement. The clinician assessed the subject's PsO lesions according to the PASI and provided this score within the case report form at Weeks 0 (as the Week 48 assessment of the parent study), 4, 12, 24, 36, and 48. Subjects were classified as having a PASI-50 response based upon 50% reduction from baseline of the parent study.
The Psoriasis Area and Severity Index (PASI) is well established in the medical literature and is internationally the most widely used instrument to assess the severity of Psoriasis. Proportion of subjects achieving PASI-75 from baseline at Week 12. This was the primary endpoint supporting a Biologics Licensing Application in the US.
Mean percent changed in PASI from baseline (last non-missing value prior to first dose) at Week 12. This was the primary endpoint supporting the Marketing Authorization Application in the EU.
The primary efficacy endpoint in Part 1 was the percentage of subjects who achieved ACR20 (20% improvement according to American College of Rheumatology criteria) at week 24 compared to baseline (last non-missing value prior to first dose). Subjects were considered an ACR20 responder if when compared to baseline (last non-missing value prior to first dose), they achieved a 20% decrease in SJC (Swollen joint count), 20% decrease in TJC (Tender joint count), and 20% improvement in 3 of the following 5 measures: high sensitivity C reactive protein(hs-CRP), Health Assessment Questionnaire Disability Index(HAQ-DI), subjects global assessment of pain(SPA, VAS), subject's global assessment of disease activity(SGA-VAS), physician's global assessment of disease activity(PGA-VAS)
| Arm | Type | Description |
|---|---|---|
| CHS-0214 | EXPERIMENTAL | CHS-0214 50 mg weekly |
| Enbrel (etanercept) | ACTIVE_COMPARATOR | Enbrel 50mg twice weekly times 12 weeks |
| Name | Type | Description |
|---|---|---|
| CHS-0214 | DRUG | Open label |
| Etanercept | DRUG | Head-to-head comparison |
Inclusion Criteria: * Have completed 48 weeks of evaluations in CHS-0214-02 and, at Week 48, had at least an ACR20, or completed 48 weeks of evaluations in CHS-0214-04 and, at Week 48, had at least a PASI-50 Exclusion Criteria: * None
CHS-0214 is an investigational small molecule developed by Coherus Oncology, Inc. (ticker CHRS) as a proposed biosimilar to etanercept. It was studied in Phase 3 clinical trials for plaque psoriasis and rheumatoid arthritis. The program includes completed active-controlled, randomized, double-blind studies in both indications.
CHS-0214 was developed for the treatment of plaque psoriasis and rheumatoid arthritis. Both are chronic inflammatory conditions, and the drug was evaluated in Phase 3 trials in adults with these diseases. It is an investigational agent and is not described as approved.
CHS-0214 targets TNF-alpha, a cytokine involved in inflammation. By binding this cytokine, the drug is designed to reduce the inflammatory signaling that drives plaque psoriasis and rheumatoid arthritis. This mechanism is the same class of action as etanercept, the reference product it was compared against in its trials.
CHS-0214 is developed by Coherus Oncology, Inc., which trades under the ticker CHRS. The company sponsored the Phase 3 clinical program evaluating the drug in plaque psoriasis and rheumatoid arthritis.
CHS-0214 has been studied in Phase 3 clinical development. Its two completed Phase 3 trials and one long-term safety extension study have finished, and no trials are currently listed as active. It is an investigational product rather than a marketed therapy.
CHS-0214 was evaluated in Phase 3 studies including NCT02134210 in chronic plaque psoriasis and NCT02115750 in rheumatoid arthritis, both comparing it with Enbrel (etanercept). A long-term safety extension study, NCT02486939, enrolled patients with rheumatoid arthritis and plaque psoriasis in Japan. All three trials are completed.
CHS-0214 is a proposed biosimilar to etanercept, the active ingredient in Enbrel. Its Phase 3 trials were designed as comparisons against Enbrel (etanercept) in plaque psoriasis and rheumatoid arthritis. CHS-0214 is a distinct investigational product developed by Coherus Oncology, Inc.