Table 12.
Summary of findings table for treatment with galcanezumab 240 mg monthly subcutaneous injection 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 galcanezumab | |||||
| Reduction in migraine daysfollow up: 6 months | The mean reduction in migraine days was − 2.6 days | The mean reduction in migraine days in the intervention group was 1.9 days fewer (2.3 fewer to 1.4 fewer) | – | 1330(2 RCT) | ⨁⨁⨁⨁HIGH | Treatment with galcanezumab 240 mg results in reduction in migraine days compared with placebo. |
| Reduction in use of acute attack medication follow up: 6 months | The mean reduction in use of acute attack medication was − 2.1 days | The mean reduction in use of acute attack medication in the intervention group was 1.7 days fewer (1.9 fewer to 1.4 fewer) | – | 1330(2 RCT) | ⨁⨁⨁⨁HIGH | Treatment with galcanezumab 240 mg results in reduction in use of attack medication compared with placebo. |
| Improvement in functional MSQ RFR score follow up: 6 months | The mean improvement in functional MSQ RFR score was 22.2 points | The mean improvement in functional MSQ RFR score in the intervention group was 7.3 points higher (5.6 higher to 9.1 higher) | – | 1330(2 RCT) | ⨁⨁⨁⨁HIGH | Treatment with galcanezumab 240 mg results in improvement in functional MSQ RFR score compared with placebo. |
| At least 50% reduction in days of migrainefollow up: 6 months | 372 per 1000 | 586 per 1000(522 to 658) | RR 1.5738(1.4013 to 1.7675) | 1330(2 RCT) | ⨁⨁⨁⨁HIGH | Treatment with galcanezumab 240 mg results in at least 50% reduction of days of migraine compared with placebo. |
| Serious adverse events follow up: 6 months | 11 per 1000 | 16 per 1000(6 to 41) | RR 1.3953(0.5347 to 3.6413) | 1330(2 RCT) | ⨁⨁⨁⨁HIGH | Treatment with galcanezumab 240 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 | 1330(2 RCT) | No deaths occurred during the double-blind treatment phase of the trial. | |
CI: Confidence interval; RR: Risk ratio; RCT: randomized controlled trial
GRADE Working Group grades of evidenceHigh 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.
The mean reduction in migraine days for galcanezumab was changed from 1.8 to 1.9 the mean reduction was changed from 1.6 to 1.7 and the mean improvement from 7.4 to 7.3.
The numbers for "at least 50% reduction in days of migraine" was changed from 386 to 372, with modifications throughout the line. The "serious adverse events" are now reported as 11 per 1000 instead of 12 per 1000, with modifications throughout the line.
The number of participants (studies) was changed to 1330 (2 RCT).
The certainty of the evidence was changed from Medium to High