The tofacitinib clinical development programme to assess efficacy and safety included 2 multicentre, randomised, double-blind, placebo-controlled, confirmatory trials in 816 patients 18 years of age and older (PsA-I and PsA-II).1
Although other doses have been studied, the recommended dose of tofacitinib is 5 mg BID. Tofacitinib 10 mg BID is not recommended for the treatment of PsA.
The PsA-I study was a 12-month clinical trial conducted in 422 patients who had an inadequate response to a nonbiologic DMARD (67% and 33% were IRs to 1 nonbiologic DMARD and ≥2 nonbiologic DMARDs, respectively) and who were naïve to treatment with a TNF blocker.
The PsA-II study was a 6-month clinical trial conducted in 394 patients who had an inadequate response to at least 1 approved TNF blocker (66%, 19% and 15% were IRs to 1 TNF blocker, 2 TNF blockers and ≥3 TNF blockers, respectively).
Proportion of Patients With an ACR Response in the PsA-I* Study (Nonbiologic DMARD IRs [TNF Blocker-naïve])
Example
Subjects with missing data were treated as non-responders.
*Subjects received 1 concomitant nonbiologic DMARD.
†N is the number of randomised and treated patients.
The percentage of ACR20 responders by visit for the PsA-I study is shown in the figure below. Similar responses were observed in the PsA-II study. In both the studies, improvements in the ACR20 response on tofacitinib were observed at the first visit after baseline (Week 2).
Percentage of ACR20 Responders by Visit Through Month 3 in the PsA-I* Study
Adapted from Xeljanz. Local product document. 2022.
Proportion of Patients With an ACR Response in the PsA-II* Study (TNF Blocker IRs)
Subjects with missing data were treated as non-responders.
*Subjects received 1 concomitant nonbiologic DMARD.
†N is the number of randomised and treated patients.
Improvements from baseline in the ACR response criteria components for both the studies are shown in the table below.
Components of ACR Response at Baseline and Month 3 in Studies PsA-I and PsA-II
*Subjects received 1 concomitant nonbiologic DMARD.
†Data shown are the mean value at baseline and at Month 3.
‡VAS: 0 = best, 100 = worst.
§HAQ-DI: 0 = best, 3 = worst; 20 questions; categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and activities.
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ACR, American College of Rheumatology; BID, twice daily; CI, confidence interval; CRP, C-reactive protein; DMARD, disease-modifying antirheumatic drug; HAQ-DI, Health Assessment Questionnaire-Disability Index; IR, inadequate responder; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; SE, sensory epithelium; TNF, tumour necrosis factor; VAS, visual analogue scale.
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