The evidence is based on 3 RCTs. The evidence is downgraded due to imprecision.
| Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias «Certolizumab pegol in treatment of moderate to severe plaque psoriasis: effectiveness and safety compared to placebo»1 |
|---|---|---|---|---|---|
| RCT=randomized controlled trial; PGA=Physician's Global Assessment, CZP= certolizumab pegol, s.c.=subcutaneous treatment, DLQI= Dermatology Life Quality Index | |||||
| «Gottlieb AB, Blauvelt A, Thaçi D ym. Certolizumab ...»1 | pooled analysis of 2 RCTs | Adult patients (>18 years of age) from North America and Europe with moderate to severe
plaque psoriasis. N=461 |
CZP 400 mg s.c. every2 weeks (n=175), CZP 200 mg every 2 weeks (after loading dose of CZP 400 mg at weeks 0, 2, and 4) (n=186), or placeboevery 2 weeks (n=100) | Primary at 16 weeks PASI 75 and PGA 0/1.Secondary PASI 90, change in DLQI atweek 16 | After 16 weeks the randomization was dissolved |
| «Lebwohl M, Blauvelt A, Paul C ym. Certolizumab peg...»2 | RCT | Adult patients (>18 years of age) from North America and Europe with moderate to severe
plaque psoriasis. N=461 |
CZP 400 mg s.c. every2 weeks (n=175), CZP 200 mg every 2 weeks (after loading dose of CZP 400 mg at weeks 0, 2, and 4) (n=186), or placeboevery 2 weeks (n=100) | Primary PASI 75 CZP (any dose) vs placebo at 12 weeks.Secondary PASI75 at week 16; PGA0/1 atweeks 12 and 16; PASI 90 atweeks 12 and 16 | Randomization |
Results
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Relative effect (95% CI) |
|---|---|---|---|---|---|
| I= intervention; C=comparison; CI=confidence interval, PGA=Physician's Global Assessment, CZP= certolizumab pegol | |||||
| «Gottlieb AB, Blauvelt A, Thaçi D ym. Certolizumab ...»1 | 2 RCTs CZP 400 n=175 CZP 200 n=186 Placebo n=100 |
16 weeks | (65.3) (56.8) |
(2.7) | OR CZP 400 vs. placebo 69.5 (16.5 to 292.0) CZP 200 vs. placebo 48.7 (11.7 to 203.3) |
| «Lebwohl M, Blauvelt A, Paul C ym. Certolizumab peg...»2 | 1 RCT CZP 400 n=167 CZP 200 n=165 Placebo n=157 |
Week 16 | (58.4) (48.3) |
(3.4) | OR CZP 400 vs. placebo 40.7 (9.7 to 170.2) CZP 200 vs. placebo 27.2 (6.5 to 113.5) |
| Level of evidence: moderate The quality of evidence is downgraded 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 | Relative effect (95% CI) |
|---|---|---|---|---|---|
| I= intervention; C=comparison; CI=confidence interval, CZP= certolizumab pegol | |||||
| «Gottlieb AB, Blauvelt A, Thaçi D ym. Certolizumab ...»1 | 2 RCTs CZP 400 n=175 CZP 200 n=186 Placebo n=100 |
16 weeks | (52.2)(45.9) | (2.5) | OR CZP 400 vs. placebo 44.1 (8.6 to 226.5) CZP 200 vs. placebo 34.3 (6.7 to 175.7) |
| «Lebwohl M, Blauvelt A, Paul C ym. Certolizumab peg...»2 | 1 RCT CZP 400 n=167 CZP 200 n=165 Placebo n=157 |
16 weeks | (49.1)(39.8) | (0.3) | OR CZP 400 vs. placebo 72.3 (14.7 to 356.6) CZP 200 vs. placebo 49.5 (10.0 to 245.3) |
| Level of evidence: moderate The quality of evidence is downgraded due to indirectness (secondary outcome) and imprecision (wide CIs). |
|||||
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Relative effect (95% CI) |
|---|---|---|---|---|---|
| «Gottlieb AB, Blauvelt A, Thaçi D ym. Certolizumab ...»1 | 2 RCTs CZP 400 n=175 CZP 200 n=186 Placebo n=100 |
16 weeks | All 117 (67) 106 (57) Serious 9 (5) 4 (2) |
All 61 (61) Serious 1 (1) |
NA |
| «Lebwohl M, Blauvelt A, Paul C ym. Certolizumab peg...»2 | 1 RCT CZP 400 n=167 CZP 200 n=165 Placebo n=157 |
12 weeks | All 82 (49.1) 78 (47.3) Serious 4 (2.4) 1 (0.6) |
All 32 (56.1) Serious 5 (8.8) |
NA |
| Level of evidence: low The quality of evidence is downgraded due to indirectness (short follow-up time) and imprecision. |
|||||