Tofacitinib treatment in patients with active psoriatic arthritis: effectiveness compared to placebo
Näytönastekatsaukset
10.11.2021
Level of evidence: B
Tofacitinib treatment at the dose of 5 mg twice daily, when compared to placebo, seems to increase the proportion of patients with active psoriatic arthritis achieving the ACR20 response at week 12 (50–60 % vs. 25–30 %).
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 Adalimumab versus Placebo for Psoriatic Arthritis. N Engl J Med 2017;377:1537-1550 »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 Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors. N Engl J Med 2017;377:1525-1536 »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 Adalimumab versus Placebo for Psoriatic Arthritis. N Engl J Med 2017;377:1537-1550 »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 Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors. N Engl J Med 2017;377:1525-1536 »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 Adalimumab versus Placebo for Psoriatic Arthritis. N Engl J Med 2017;377:1537-1550 »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 Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors. N Engl J Med 2017;377:1525-1536 »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 Adalimumab versus Placebo for Psoriatic Arthritis. N Engl J Med 2017;377:1537-1550 »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 Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors. N Engl J Med 2017;377:1525-1536 »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 Adalimumab versus Placebo for Psoriatic Arthritis. N Engl J Med 2017;377:1537-1550 »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 Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors. N Engl J Med 2017;377:1525-1536 »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 Adalimumab versus Placebo for Psoriatic Arthritis. N Engl J Med 2017;377:1537-1550 »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 Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors. N Engl J Med 2017;377:1525-1536 »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 | |||||
References
- Mease P, Hall S, FitzGerald O ym. Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis. N Engl J Med 2017;377:1537-1550 «PMID: 29045212»PubMed
- Gladman D, Rigby W, Azevedo VF ym. Tofacitinib for Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors. N Engl J Med 2017;377:1525-1536 «PMID: 29045207»PubMed