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. Effica...»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...»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 Carry-over effect (Previous and continuing use of methotrexate; previous use of anti-TNF treatment) |
| Reference | Comments |
|---|---|
| «Mease PJ, Gottlieb AB, van der Heijde D ym. Effica...»1 | This multicenter international study was funded by Bristol-Myers Squibb. Those patients not responding at week 16 (35.7 % of abatacept and 42.2 % of placebo group patients) were imputed as non-responders at week 24 and received open abatacept treatment thereafter. |
| «Mease P, Genovese MC, Gladstein G ym. Abatacept in...»2 | This multicenter international study was funded by Bristol-Myers Squibb. |
| «Simons N, Degboé Y, Barnetche T ym. Biological DMA...»3 and «Ruyssen-Witrand A, Perry R, Watkins C ym. Efficacy...»4 | There are no other RCT studies of abatacept, but two systematic reviews/meta-analysis comparing different bDMARDs with placebo in PsA (ref «Simons N, Degboé Y, Barnetche T ym. Biological DMA...»3 and «Ruyssen-Witrand A, Perry R, Watkins C ym. Efficacy...»4). |
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. Effica...»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...»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. Effica...»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...»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. Effica...»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...»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.