Prescription and acceptance of durable medical equipment in FORTITUDE-ALS, a study of reldesemtiv in ALS: post hoc analyses of a randomized, double-blind, placebo-controlled clinical trial

Figures & data

Figure 1. FORTITUDE-ALS trial design. ALS: amyotrophic lateral sclerosis; bid: twice daily.

Table 1. Baseline ALSFRS-R scores for items 1, 3, 5, and 8 for patients in the placebo and reldesemtiv groups.

Response at baseline, n (%)	Reldesemtiv (n = 342)	Placebo (n = 114)
Item 1: Speech
4: Normal speech processes	164 (48.0)	57 (50.0)
3: Detectable speech disturbance	103 (30.1)	38 (33.3)
2: Intelligible with repeating	56 (16.4)	14 (12.3)
1: Speech combined with non-vocal communication	18 (5.3)	4 (3.5)
0: Loss of useful speech	1 (0.3)	1 (0.9)
Either 0 or 1	19 (5.6)	5 (4.4)
Item 3: Swallowing
4: Normal eating habits	212 (62.0)	80 (70.2)
3: Early eating problems, occasional choking	93 (27.2)	19 (16.7)
2: Dietary consistency changes	36 (10.5)	15 (13.2)
1: Needs supplemental tube feedings	1 (0.3)	0 (0)
Either 0 or 1	1 (0.3)	0 (0)
Item 5: Cutting food/handling utensils
Patients who used 5A to answer question (without gastrostomy)	341 (99.7)	114 (100)
Patients who used 5B to answer question (with gastrostomy)	1 (0.3)	0 (0)
Item 8: Walking
4: Normal	98 (28.7)	22 (19.3)
3: Early ambulation difficulties	76 (22.2)	22 (19.3)
2: Walks with assistance	150 (43.9)	55 (48.3)
1: Non-ambulatory functional movement only	14 (4.1)	13 (11.4)
0: No purposeful leg movement	4 (1.2)	2 (1.8)
Either 0 or 1	18 (5.3)	15 (13.2)

ALSFRS-R: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised.

Figure 2. Probability of no new DME-PAP over time with reldesemtiv treatment compared with placebo. (A) Each dose of reldesemtiv, and (B) for all doses of reldesemtiv combined. Numbers of patients per group are indicated on top of the x-axis. bid: twice daily; DME-PAP: durable medical equipment prescribed and accepted by the patient.

Table 2. Hazard ratios^a for reldesemtiv compared with placebo for at least one DME-PAP over the course of the trial.

Reldesemtiv group	Hazard ratio vs placebo	95% CI	p Value^b
150 mg bid	0.43	0.23, 0.79	0.006
300 mg bid	0.81	0.46, 1.43	0.473
450 mg bid	0.66	0.38, 1.14	0.137
All doses combined	0.61	0.39, 0.96	0.032

bid: twice daily; CI: confidence interval; DME-PAP: durable medical equipment prescribed and accepted by the patient.

^a Hazard ratio for the time to patients prescribed and agreeing to receive at least one DME of noninvasive ventilation, gastrostomy tube, manual wheelchair, power wheelchair, or augmentative and alternative communication.

^b The p value was obtained from a Cox regression model stratified by pooled site, riluzole use, and edaravone use, with treatment and scores of ALSFRS-R items 1, 3, 5, and 8 as covariates. Patients who did not have an event were censored at the last date of study visit.

Figure 3. Proportion of DME-PAP by treatment group over the course of the trial. bid: twice daily; DME-PAP: durable medical equipment prescribed and accepted by the patient. p Values for reldesemtiv versus placebo were obtained from a Chi-square test.

Data availability statement

Data reported herein are part of a sponsor-led clinical development program that is ongoing, and thus complete datasets for the trial will not be made available with this report.