ACR20 RESPONSE @ 16 WEEKS: OTEZLA DEMONSTRATED A STATISTICALLY SIGNIFICANT IMPROVEMENT VS. PLACEBO (1° ENDPOINT)1,9
Intent-to-treat population; non-responder imputation.
Adapted from the OTEZLA Product Monograph, 2020, and Kavanaugh, A et al., 2014.1,9
Overall, the greater proportions of patients who achieved ACR20 did not appear to be primarily driven by mean improvements on any specific ACR component score(s) (i.e., number of tender joints, number of swollen joints, patient’s assessment of pain, patient’s global assessment of disease, physician’s global assessment of disease, HAQ-DI, and C-reactive protein).1
ACR20 RESPONSE @ 52 WEEKS: NO
EVIDENCE OF ATTENUATION OF
EFFICACY
ON ACR20 WAS SEEN FOR UP TO 52 WEEKS
OF TREATMENT WITH OTEZLA (UNCONTROLLED FROM WEEKS 24–52)1,8
| Study week | 16 | 24 | 40 | 52 |
|---|---|---|---|---|
| OTEZLA 30 mg BID ± DMARDs, n/m | 64/150 | 73/145 | 80/140 | 71/130 |
Patients receiving OTEZLA 30 mg BID from baseline. Data as observed.
Adapted from the OTEZLA Product Monograph, 2020, and Kavanaugh A, et al., 2015.1,8
ACR, American College of Rheumatology; BID, twice daily; DMARD, disease-modifying anti-rheumatic drug; HAQ-DI, Health Assessment
Questionnaire-Disability Index; PsA, psoriatic arthritis.