ACR20 Response Rate

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])

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.