The proportion of patients with active psoriatic arthritis and treated with tofacitinib achieving ACR50 and ACR 70 response at week 12 may be higher compared to patients treated with placebo. The safety profile may be similar to placebo.
| Ref. | Study type | Population | Intervention and comparison | Outcomes | Risk of bias |
|---|---|---|---|---|---|
| RCT=randomized controlled trial. ARC20=20% improvement in signs and symptoms of psoriatic arthritis according to American College of Rheumatology criteria, TOF=tofacitinib | |||||
| «Mease P, Hall S, FitzGerald O ym. Tofacitinib or A...»1 | RCT | 316 TNFi-naïve adults (>18) with active psoriatic arthritis receiving one background csDMARD and inadequate response to at least 1 csDMARD. | TOF 5 or 10 mg twice daily vs. placebo | Primary: ACR20 and HAQ-DI at week 12; Secondary: ACR50, ACR70, PASI75 adverse events |
Low |
| «Gladman D, Rigby W, Azevedo VF ym. Tofacitinib for...»2 | RCT | 395 adults with active psoriatic arthritis receiving one background csDMARD and with inadequate response to at least one TNFi | TOF 5 or 10 mg twice daily vs. placebo | Primary: ACR20 and HAQ-DI at week 12; Secondary: ACR50, ACR70, PASI75 adverse events |
Low |
| Reference | Comments |
|---|---|
| «Mease P, Hall S, FitzGerald O ym. Tofacitinib or A...»1 | Phase 3 multicenter, double-blind RCT, included in the pooled analysis [1]. All patients
received one background csDMARD throughout the study. One arm was randomized to subcutaneous
adalimumab and therefore blinding is not entirely possible. There was some unbalance
in the baseline characteristics between the groups. Placebo group was switched to
tofacitinib at 3 months. Follow-up up to 1 year. The study was funded by Pfizer Inc. |
| «Gladman D, Rigby W, Azevedo VF ym. Tofacitinib for...»2 | Phase 3 multicenter, double-blind RCT, included in the pooled analysis [1]. All patients
received one background csDMARD throughout the study. There was some unbalance in
the baseline characteristics between the groups. Placebo group was switched to tofacitinib
at 3 months. Follow-up up to 6 months. 84-93% completed the trial. The study was funded by Pfizer Inc. |
Results
| Reference | Number of studies and number of patients (I/C) | Follow-up time, weeks | Absolute number of events (%) I | Absolute number of events (%) C | Absolute difference vs. placebo (95% CI)* |
|---|---|---|---|---|---|
| I= intervention; C=comparison; CI=confidence interval, TOF=tofacitinib * Not stated in the publication |
|||||
| «Mease P, Hall S, FitzGerald O ym. Tofacitinib or A...»1 | 1 RCT 316 (107 TOF 5 mg/ 104 TOF 10 mg / 55 placebo) |
12 | TOF 5mg: 54 (50.0) TOF 10 mg: 63 (61.0) |
35 (33) | 17 % 28 % |
| «Gladman D, Rigby W, Azevedo VF ym. Tofacitinib for...»2 | 1 RCT 395 (131 TOF 5 mg/ 132 TOF 10 mg / 131 placebo) |
12 | TOF 5mg: 65 (50.0) TOF 10 mg: 62 (47) |
31 (24) | 26 % 23 % |
| Level of evidence: moderate The level of evidence is downgraded due to imprecision (no confidence intervals reported). |
|||||
| Reference | Number of studies and number of patients (I/C) | Follow-up time, weeks | Absolute number of events (%) I | Absolute number of events (%) C | Absolute difference vs. placebo (95% CI)* |
|---|---|---|---|---|---|
| I=intervention; C=comparison; CI=confidence interval, TOF=tofacitinib * Not stated in the publication |
|||||
| «Mease P, Hall S, FitzGerald O ym. Tofacitinib or A...»1 | 1 RCT 316 (107 TOF 5 mg/ 104 TOF 10 mg / 55 placebo) |
12 | TOF 5mg: 30 (28) TOF 10 mg: 42 (40) |
10 (10) | 18 % 30 % |
| «Gladman D, Rigby W, Azevedo VF ym. Tofacitinib for...»2 | 1 RCT 395 (131 TOF 5 mg/ 132 TOF 10 mg / 131 placebo) |
12 | TOF 5mg: 29 (30) TOF 10 mg: 37 (28) |
19 (15) | 15% 22 % |
| Level of evidence: moderate The level of evidence is downgraded due to imprecision (no confidence intervals reported). |
|||||
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Absolute difference vs. placebo (95% CI)* |
|---|---|---|---|---|---|
| I=intervention; C=comparison; CI=confidence interval, TOF=tofacitinib * Not stated in the publication |
|||||
| «Mease P, Hall S, FitzGerald O ym. Tofacitinib or A...»1 | 1 RCT 316 (107 TOF 5 mg/ 104 TOF 10 mg / 55 placebo) |
12 | TOF 5mg: 18 (17) TOF 10 mg: 15 (14) |
5 (5) | 12 % 9 % |
| «Gladman D, Rigby W, Azevedo VF ym. Tofacitinib for...»2 | 1 RCT 395 (131 TOF 5 mg/ 132 TOF 10 mg / 131 placebo) |
12 | TOF 5mg: 22 (17) TOF 10 mg: 19 (14) |
13 (10) | 7 % 4 % |
| Level of evidence: moderate The level of evidence is downgraded due to imprecision (no confidence intervals reported). |
|||||
| Reference | Number of studies and number of patients (I/C) | Follow-up time, weeks | Absolute number of events (%) I | Absolute number of events (%) C | Absolute difference vs. placebo (95% CI) |
|---|---|---|---|---|---|
| I=intervention; C=comparison; CI=confidence interval, TOF=tofacitinib | |||||
| «Mease P, Hall S, FitzGerald O ym. Tofacitinib or A...»1 | 1 RCT 316 (107 TOF 5 mg/ 104 TOF 10 mg / 55 placebo) |
12 | At least one AE TOF 5 mg (39) TOF 10 mg: (45) Serious AE 1 TOF 5 mg (3) TOF 10 mg: (1) |
At least one AE (35) Serious AE 1 (1) |
NA |
| «Gladman D, Rigby W, Azevedo VF ym. Tofacitinib for...»2 | 1 RCT 395 (131 TOF 5 mg/ 132 TOF 10 mg / 131 placebo) |
12 | At least one AE TOF 5 mg 72 (55) TOF 10 mg: 70 (53) Serious AE 1 TOF 5 mg 1 (1) TOF 10 mg: 3 (2) |
At least one AE 58 (44) Serious AE 1 3 (2) |
NA |
| Level of evidence: low | |||||