The results were also similar with the dose of 140mg brodalumab (45.8 % vs. 20.9 %, P<0.0001) at weeks 16 (and 24). Significantly higher ACR50 and ACR70 response rates for both doses were observed for brodalumab compared to placebo at weeks 16 and 24 as well, but it was observed more slowly. Both doses are associated with substantial effects in both joint-related and skin-related endpoints versus placebo in patients with PsA and these improvements are maintained through 24 weeks.
| Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias |
|---|---|---|---|---|---|
| RCT=randomized controlled trial, PsA=psoriatic arthritis, NSAID=non-steroidal anti-inflammatory drug, DMARD=disease mosifying anti-rheumatic drug, ACR=American College of Rheumatology, PASI=Psoriasis Area and Severity Index, HAQ-DI= Health Assessment Questionnaire-Disability Index, PASDAS=Psoriatic Arthritis Disease Activity Score, CDAI=Clinical Disease Activity Index Score, NRI=non-responder imputation. | |||||
| «Mease PJ, Helliwell PS, Hjuler KF ym. Brodalumab i...»1 | RCT, pooled results of 2 phase III studies | Total of 962 adult patients with active PsA with an inadequate response or intolerance
to conventional treatment with NSAIDs and/or DMARDs. Concomitant NSAIDs, DMARDs and corticosteroids were permitted. |
Subcutaneous brodalumab 210 mg (n=322) or 140 mg (n=318) on day 1, and weeks 1, 2
and then every other week until week 22 vs. placebo (n=322) |
Primary: ACR20 at week 16 (and week 24) Secondary: ACR50 at week 16 (and 24), ACR70 at week 16 (and 24), PASI, HAQ-DI, Disease activity score, improvement in dactylitis and enthesitis, PASDAS, CDAI, adverse events |
Moderate Incomplete data |
| Reference | Comments |
|---|---|
| «Mease PJ, Helliwell PS, Hjuler KF ym. Brodalumab i...»1 |
|
Results
| Reference | Number of studies and number of patients | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Relative effect (p-value) |
|---|---|---|---|---|---|
| I=intervention; C=comparison; CI=confidence interval | |||||
| «Mease PJ, Helliwell PS, Hjuler KF ym. Brodalumab i...»1 | Two phase III studies. Total of 962 patients: n=322 (Bro 210mg) n=318 (Bro 140mg) n=322 (Placebo) |
16 weeks | Brodalumab 210mg at 16 weeks (47.9 %) Brodalumab 140mg at 16 weeks (45.8 %) |
20.9 % | 27 % (p<0.0001) 24.9 % (p<0.0001) |
| Level of evidence: moderate The quality of evidence is downgraded due to imprecision; confidence intervals to the relative effect are not reported. |
|||||
| 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 (p-value) |
|---|---|---|---|---|---|
| I=intervention; C=comparison; CI=confidence interval | |||||
| «Mease PJ, Helliwell PS, Hjuler KF ym. Brodalumab i...»1 | Two phase III studies. Total of 962 patients: n=322 (Bro 210mg) n=318 (Bro 140mg) n=322 (Placebo) |
24 weeks | Brodalumab 210mg at 24 weeks (53.6 %) Brodalumab 140mg at 24 weeks (51.0 %) |
23.8 % | 29.8 % (p<0.0001) 27.2 % (p<0.0001) |
| Level of evidence: moderate The quality of evidence is downgraded due to imprecision; confidence intervals to the relative effect are not reported. |
|||||
| Reference | Number of studies and number of patients | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Relative effect (p-value) |
|---|---|---|---|---|---|
| I=intervention; C=comparison; CI=confidence interval | |||||
| «Mease PJ, Helliwell PS, Hjuler KF ym. Brodalumab i...»1 | Two phase III studies. Total of 962 patients: n=322 (Bro 210mg) n=318 (Bro 140mg) n=322 (Placebo) |
16 weeks | Brodalumab 210mg at 16 weeks (26.1 %) Brodalumab 140mg at 16 weeks (24.8 %) |
7.2 % | 18.9 % (p<0.0001) 17.6 % (p<0.0001) |
| Level of evidence: moderate The quality of evidence is downgraded due to imprecision; confidence intervals to the relative effect are not reported. |
|||||
| 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 (p-value) |
|---|---|---|---|---|---|
| I= intervention; C=comparison; CI=confidence interval | |||||
| «Mease PJ, Helliwell PS, Hjuler KF ym. Brodalumab i...»1 | Two phase III studies. Total of 962 patients: n=322 (Bro 210mg) n=318 (Bro 140mg) n=322 (Placebo) |
24 weeks | Brodalumab 210mg at 24 weeks (36.4 %) Brodalumab 140mg at 24 weeks (29.8 %) |
10.4 % | 26 % (p<0.0001) 19.4 % (p<0.0001) |
| Level of evidence: moderate The quality of evidence is downgraded due to imprecision; confidence intervals to the relative effect are not reported. |
|||||
| Reference | Number of studies and number of patients | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Relative effect (p-value) |
|---|---|---|---|---|---|
| I=intervention; C=comparison; CI=confidence interval | |||||
| «Mease PJ, Helliwell PS, Hjuler KF ym. Brodalumab i...»1 | Two phase III studies. Total of 962 patients: n=322 (Bro 210mg) n=318 (Bro 140mg) n=322 (Placebo) |
16 weeks | Brodalumab 210mg at 16 weeks (12.2 %) Brodalumab 140mg at 16 weeks (11.3 %) |
3.4 % | 8.8 % (p<0.001) 7.9 % (p<0.001) |
| Level of evidence: moderate The quality of evidence is downgraded due to imprecision; confidence intervals to the relative effect are not reported. |
|||||
| 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 (p-value) |
|---|---|---|---|---|---|
| I=intervention; C=comparison; CI=confidence interval | |||||
| «Mease PJ, Helliwell PS, Hjuler KF ym. Brodalumab i...»1 | Two phase III studies. Total of 962 patients: n=322 (Bro 210mg) n=318 (Bro 140mg) n=322 (Placebo) |
24 weeks | Brodalumab 210mg at 24 weeks (20.9%) Brodalumab 140mg at 24 weeks (14.4%) |
4.7 % | 16.2 % (p<0.0001) 9.7 % (p<0.001) |
| Level of evidence: moderate The quality of evidence is downgraded due to imprecision; confidence intervals to the relative effect are not reported. |
|||||
| Reference | Number of studies and number of patients | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Relative effect |
|---|---|---|---|---|---|
| I=intervention; C=comparison; CI=confidence interval | |||||
| «Mease PJ, Helliwell PS, Hjuler KF ym. Brodalumab i...»1 | Two phase III studies. Total of 962 patients: n=322 (Bro 210mg) n=318 (Bro 140mg) n=322 (Placebo) |
16 weeks | Brodalumab 210mg at 16 weeks (54.5 %) Brodalumab 140mg at 16 weeks (51.6 %) |
54.4 % | 0.1 % -2.8 % |
| Level of evidence: moderate The quality of evidence is downgraded due to imprecision; confidence intervals to the relative effect are not reported. |
|||||
| Reference | Number of studies and number of patients | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Relative effect |
|---|---|---|---|---|---|
| I= intervention; C=comparison; CI=confidence interval | |||||
| «Mease PJ, Helliwell PS, Hjuler KF ym. Brodalumab i...»1 | Two phase III studies. Total of 962 patients: n=322 (Bro 210mg) n=318 (Bro 140mg) n=322 (Placebo) |
16 weeks | Brodalumab 210mg at 16 weeks (15.0 %) Brodalumab 140mg at 16 weeks (16.4 %) |
19.4 % | -4.4 % -3.0 % |
| Level of evidence: moderate The quality of evidence is downgraded due to imprecision; confidence intervals to the relative effect are not reported. |
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