Table 6.
Summary of findings table for treatment with eptinezumab 1000 mg single intravenous infusion compared with no treatment for prevention of episodic migraine
| Outcomes | Anticipated absolute effects*(95% CI) | Relative effect(95% CI) | № of participants (studies) | Certainty of the evidence(GRADE) | Comments | |
|---|---|---|---|---|---|---|
| Risk with placebo | Risk with eptinezumab | |||||
|
Reduction in migraine days follow up: 3 months |
The mean reduction in migraine days was −4.6 days | The mean reduction in migraine days in the intervention group was 1 days fewer (2.1 fewer to 0.2 more) | – |
151 (1 RCT) |
⨁⨁◯◯ LOWa |
Treatment with eptinezumab 1000 mg reduces the number of migraine days slightly compared with placebo. |
|
Reduction in use of acute attack medication follow up: 3 months |
The mean change in migraines with acute attack medication was + 4.1% | The mean reduction in migraines with acute attack medication was 10.4% days fewer (−20.5% fewer to −0.2% fewer) | – |
151 (1 RCT) |
⨁⨁◯◯ LOWa |
Treatment with eptinezumab 1000 mg results in a small possibly unimportant effect in reduction in use of acute attack medication compared with placebo (statistical significance of the differences not tested). |
|
Improvement in function HIT-6 score follow up: 3 months |
The mean improvement in function HIT-6 score was −7.7 points | The mean improvement in function HIT-6 score in the intervention group was 2.4 points lower (5.5 lower to 0.7 higher) | – |
151 (1 RCT) |
⨁⨁◯◯ LOWa |
Treatment with eptinezumab 1000 mg results in a small possibly unimportant effect in improvement in function assessed by means of the HIT-6 score compared with placebo (statistical significance of the differences not tested). |
|
At least 50% reduction in days of migraine follow up: 3 months |
667 per 1000 |
727 per 1000 (584 to 905) |
RR 1.1597 (0.9407 to 1.4076) |
151 (1 RCT) |
⨁⨁◯◯ LOWa |
Treatment with eptinezumab 1000 mg results in a small possibly unimportant effect in at least 50% reduction of days of migraine compared with placebo. |
|
Serious adverse events follow up: 6 months |
12 per 1000 |
24 per 1000 (2 to 264) |
RR 2.0000 (0.1849 to 21.6193) |
163 (1 RCT) |
⨁⨁◯◯ LOWa |
Treatment with eptinezumab 1000 mg results in a small possibly unimportant effect in serious adverse events occurrence compared with placebo. |
| Mortality follow up: 6 months | 0 per 1000 |
0 per 1000 (0 to 0) |
Not estimable |
163 (1 RCT) |
No deaths occurred during the double-blind treatment phase of the trial. | |
CI: Confidence interval; RR: Risk ratio; RCT: randomized controlled trial; aDowngraded twice due to inconsistency and imprecision.
GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect