Abatacept treatment in patients with active psoriatic arthritis: effectiveness compared to placebo
Näytönastekatsaukset
10.11.2021
Level of evidence: B
Parenteral abatacept 125 mg per week treatment increases the ACR20 response at week 24 in patients with active psoriatic arthritis when compared to placebo.
This may be true for ACR50 response and may not be true for ACR70 response at week 24.
| Ref. | Study type | Population | Intervention and comparison | Outcomes | Risk of bias |
|---|---|---|---|---|---|
| RCT=randomized controlled trial | |||||
| «Mease PJ, Gottlieb AB, van der Heijde D ym. Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis. Ann Rheum D»1 | RCT | 424 (213 abatacept, 211 placebo) adult patients with active psoriatic arthritis (both TNFi-naïve and TNFi-exposed, N=165 and 259) | Subcutaneous abatacept 125 mg weekly vs. placebo | Primary: ACR20 at week 24; Secondary: ACR50 at week 24, ACR70 at week 24, adverse events | Low |
| «Mease P, Genovese MC, Gladstein G ym. Abatacept in the treatment of patients with psoriatic arthritis: results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial»2 | RCT | 170 adults with active psoriatic arthritis (Total n=128 abatacept: n=43 abatacept 30/10 mg/kg n=40 abatacept 10mg/kg, n=45 abatacept 3mg/kg, n=42 placebo) Nearly 75 % of the patients had previously taken methotrexate and it was continued in approximately 60 % of patients. Approximately 20 % of the patients received concomitant corticosteroids. | Three different dosing regimens of abatacept:
Treatments were administered as iv-infusion on days 1, 15, 29 and every 28 days. 30/10 mg/kg dose was administered on days 1 and 15, and 10mg/kg thereafter. | Primary: ACR20 response on day 169 Secondary: investigator's global assessment (IGA) and scores of TL, the disability index (DI), Health assessment questionnaire (HAQ) and SF-36. Exploratory endpoints: ACR50, ACR70, PASI and MRI. Adverse events | Moderate 147 (86 %) completed the study |
Results
| 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, N/A = not available, NS=not significant *= p ≤ 0.001 | |||||
| «Mease PJ, Gottlieb AB, van der Heijde D ym. Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis. Ann Rheum D»1 | 424 (213/211) | 24 weeks | Abatacept: 84 (39.4 %) | Placebo: 47 (22.3 %) | 17.2 % (8.7-25.6 %)* |
| «Mease P, Genovese MC, Gladstein G ym. Abatacept in the treatment of patients with psoriatic arthritis: results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial»2 | 170 (128/42) n=42 placebo n=43 abatacept 30/10 mg/kg n=40 abatacept 10mg/kg n=45 abatacept 3mg/kg | 169 days (~24 weeks) | Abatacept 30/10mg/kg: 18 (42%) Abatacept 10mg/kg: 19 (48%) Abatacept 3mg/kg: 15 (33%) | Placebo: 8 (19%) | 23% (CI N/A) p=0.022 29% (CI N/A) p=0.006 14% (CI N/A) NS |
| Level of evidence: moderate | |||||
| 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, N/A = not available, NS=not significant | |||||
| «Mease PJ, Gottlieb AB, van der Heijde D ym. Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis. Ann Rheum D»1 | 424 (213/211) | 24 weeks | Abatacept: 41 (19.2 %) | Placebo: 26 (12.3 %) | 6.9 % (0.1-13.7 %) |
| «Mease P, Genovese MC, Gladstein G ym. Abatacept in the treatment of patients with psoriatic arthritis: results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial»2 | 170 (128/42) n=42 placebo n=43 abatacept 30/10 mg/kg n=40 abatacept 10mg/kg n=45 abatacept 3mg/kg | 169 days (~24 weeks) | Abatacept 30/10mg/kg: 9 (20 %) Abatacept 10mg/kg: 10 (25 %) Abatacept 3mg/kg: 8 (17 %) | Placebo: 1 (2%) | 18 % (CI N/A) NS 23 % (CI N/A) NS 15 % (CI N/A) NS |
| Level of evidence: low, due to imprecision | |||||
| 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, N/A = not available, NS=not significant | |||||
| «Mease PJ, Gottlieb AB, van der Heijde D ym. Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis. Ann Rheum D»1 | 424 (213/211) | 24 weeks | Abatacept: 22 (10.3 %) | Placebo: 14 (6.6 %) | 3.7 % (-1.5–8.9) |
| «Mease P, Genovese MC, Gladstein G ym. Abatacept in the treatment of patients with psoriatic arthritis: results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial»2 | 170 (128/42) n=42 placebo n=43 abatacept 30/10 mg/kg n=40 abatacept 10mg/kg n=45 abatacept 3mg/kg | 169 days (~24 weeks) | Abatacept 30/10mg/kg: 2 (4 %) Abatacept 10mg/kg: 5 (13 %) Abatacept 3mg/kg: 4 (8 %) | Placebo: 0 (0%) | 4 % (CI N/A) NS 13 % (CI N/A) NS 8 % (CI N/A) NS |
| Level of evidence: low, due to imprecision | |||||
Other endpoints
Study 1:
There were no between groups differences in adverse events.
Study 2:
There were no between groups differences in adverse events.
References
- Mease PJ, Gottlieb AB, van der Heijde D ym. Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis. Ann Rheum Dis 2017;76:1550-1558 «PMID: 28473423»PubMed
- Mease P, Genovese MC, Gladstein G ym. Abatacept in the treatment of patients with psoriatic arthritis: results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial. Arthritis Rheum 2011;63:939-48 «PMID: 21128258»PubMed
- Simons N, Degboé Y, Barnetche T ym. Biological DMARD efficacy in psoriatic arthritis: a systematic literature review and meta-analysis on articular, enthesitis, dactylitis, skin and functional outcomes. Clin Exp Rheumatol 2020;38:508-515 «PMID: 31969228»PubMed
- Ruyssen-Witrand A, Perry R, Watkins C ym. Efficacy and safety of biologics in psoriatic arthritis: a systematic literature review and network meta-analysis. RMD Open 2020;6: «PMID: 32094304»PubMed