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Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials.

Noble PW, Albera C, Bradford WZ, Costabel U, du Bois RM, Fagan EA, Fishman RS, Glaspole I, Glassberg MK, Lancaster L, Lederer DJ, Leff JA, Nathan SD, Pereira CA, Swigris JJ, Valeyre D, King TE - Eur. Respir. J. (2015)

Bottom Line: Pooled analyses of outcomes at 1 year were based on the pre-specified end-points and analytic methods described in the ASCEND study protocol.A total of 1247 patients were included in the analysis.At 1 year, pirfenidone reduced the proportion of patients with a ≥10% decline in per cent predicted forced vital capacity or death by 43.8% (95% CI 29.3-55.4%) and increased the proportion of patients with no decline by 59.3% (95% CI 29.0-96.8%).A treatment benefit was also observed for progression-free survival, 6-min walk distance and dyspnoea.

View Article: PubMed Central - PubMed

Affiliation: Cedars-Sinai Medical Center, Los Angeles, CA, USA Paul.Noble@cshs.org.

No MeSH data available.


Related in: MedlinePlus

Secondary outcomes. a) Proportion of patients with a decline in 6-min walk distance ≥50 m or death. Rank ANCOVA (pirfenidone 2403 mg·day−1versus placebo). b) Progression-free survival at 1 year. Time to death or disease progression (confirmed ≥10% decline in forced vital capacity % predicted or ≥50 m decline in 6-min walk distance). c) Proportion of patients with an increase in UCSD SOBQ score ≥20 points or death. Rank ANCOVA (pirfenidone 2403 mg·day−1versus placebo). HR: hazard ratio; UCSD SOBQ: University of California San Diego Shortness of Breath Questionnaire (scale 0–120; higher scores indicate worse dyspnoea). #: Cox proportional hazards model; ¶: log-rank test.
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Figure 3: Secondary outcomes. a) Proportion of patients with a decline in 6-min walk distance ≥50 m or death. Rank ANCOVA (pirfenidone 2403 mg·day−1versus placebo). b) Progression-free survival at 1 year. Time to death or disease progression (confirmed ≥10% decline in forced vital capacity % predicted or ≥50 m decline in 6-min walk distance). c) Proportion of patients with an increase in UCSD SOBQ score ≥20 points or death. Rank ANCOVA (pirfenidone 2403 mg·day−1versus placebo). HR: hazard ratio; UCSD SOBQ: University of California San Diego Shortness of Breath Questionnaire (scale 0–120; higher scores indicate worse dyspnoea). #: Cox proportional hazards model; ¶: log-rank test.

Mentions: In the pooled analysis of change from baseline to 1 year in 6MWD, pirfenidone reduced the proportion of patients with a ≥50 m decline or death by 28.7% (95% CI 15.1–40.2) compared with placebo. A total of 153 (24.8%) patients in the pirfenidone group experienced a ≥50 m decline in 6MWD or death compared with 214 (34.8%) patients in the placebo group (p<0.001; figure 3a). Additionally, pirfenidone reduced the risk of death or disease progression at 1 year by 38% compared with placebo (hazard ratio 0.62, 95% CI 0.51–0.75; p<0.001; figure 3b). Fewer patients in the pirfenidone group compared with placebo experienced a qualifying event for each component of the composite end-point, including a confirmed ≥10% decline in FVC % pred (6.7% versus 13.6%), a confirmed ≥50 m decline in 6MWD (16.9% versus 20.7%) and death (3.0% versus 5.1%). Finally, pooled analysis of dyspnoea outcomes showed that fewer patients in the pirfenidone group compared with placebo experienced a ≥20-point increase in the UCSD SOBQ score or death at month 12 (148 (24.0%) patients in the pirfenidone versus 194 (31.4%) patients in the placebo group; relative difference 23.7%, 95% CI 8.4–36.4; p=0.047; figure 3c).FIGURE 3


Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials.

Noble PW, Albera C, Bradford WZ, Costabel U, du Bois RM, Fagan EA, Fishman RS, Glaspole I, Glassberg MK, Lancaster L, Lederer DJ, Leff JA, Nathan SD, Pereira CA, Swigris JJ, Valeyre D, King TE - Eur. Respir. J. (2015)

Secondary outcomes. a) Proportion of patients with a decline in 6-min walk distance ≥50 m or death. Rank ANCOVA (pirfenidone 2403 mg·day−1versus placebo). b) Progression-free survival at 1 year. Time to death or disease progression (confirmed ≥10% decline in forced vital capacity % predicted or ≥50 m decline in 6-min walk distance). c) Proportion of patients with an increase in UCSD SOBQ score ≥20 points or death. Rank ANCOVA (pirfenidone 2403 mg·day−1versus placebo). HR: hazard ratio; UCSD SOBQ: University of California San Diego Shortness of Breath Questionnaire (scale 0–120; higher scores indicate worse dyspnoea). #: Cox proportional hazards model; ¶: log-rank test.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4697914&req=5

Figure 3: Secondary outcomes. a) Proportion of patients with a decline in 6-min walk distance ≥50 m or death. Rank ANCOVA (pirfenidone 2403 mg·day−1versus placebo). b) Progression-free survival at 1 year. Time to death or disease progression (confirmed ≥10% decline in forced vital capacity % predicted or ≥50 m decline in 6-min walk distance). c) Proportion of patients with an increase in UCSD SOBQ score ≥20 points or death. Rank ANCOVA (pirfenidone 2403 mg·day−1versus placebo). HR: hazard ratio; UCSD SOBQ: University of California San Diego Shortness of Breath Questionnaire (scale 0–120; higher scores indicate worse dyspnoea). #: Cox proportional hazards model; ¶: log-rank test.
Mentions: In the pooled analysis of change from baseline to 1 year in 6MWD, pirfenidone reduced the proportion of patients with a ≥50 m decline or death by 28.7% (95% CI 15.1–40.2) compared with placebo. A total of 153 (24.8%) patients in the pirfenidone group experienced a ≥50 m decline in 6MWD or death compared with 214 (34.8%) patients in the placebo group (p<0.001; figure 3a). Additionally, pirfenidone reduced the risk of death or disease progression at 1 year by 38% compared with placebo (hazard ratio 0.62, 95% CI 0.51–0.75; p<0.001; figure 3b). Fewer patients in the pirfenidone group compared with placebo experienced a qualifying event for each component of the composite end-point, including a confirmed ≥10% decline in FVC % pred (6.7% versus 13.6%), a confirmed ≥50 m decline in 6MWD (16.9% versus 20.7%) and death (3.0% versus 5.1%). Finally, pooled analysis of dyspnoea outcomes showed that fewer patients in the pirfenidone group compared with placebo experienced a ≥20-point increase in the UCSD SOBQ score or death at month 12 (148 (24.0%) patients in the pirfenidone versus 194 (31.4%) patients in the placebo group; relative difference 23.7%, 95% CI 8.4–36.4; p=0.047; figure 3c).FIGURE 3

Bottom Line: Pooled analyses of outcomes at 1 year were based on the pre-specified end-points and analytic methods described in the ASCEND study protocol.A total of 1247 patients were included in the analysis.At 1 year, pirfenidone reduced the proportion of patients with a ≥10% decline in per cent predicted forced vital capacity or death by 43.8% (95% CI 29.3-55.4%) and increased the proportion of patients with no decline by 59.3% (95% CI 29.0-96.8%).A treatment benefit was also observed for progression-free survival, 6-min walk distance and dyspnoea.

View Article: PubMed Central - PubMed

Affiliation: Cedars-Sinai Medical Center, Los Angeles, CA, USA Paul.Noble@cshs.org.

No MeSH data available.


Related in: MedlinePlus