SUSTAINED IMPROVEMENT IN SKIN DISEASE-SPECIFIC QUALITY OF LIFE IN PATIENTS WITH MODERATE TO SEVERE PSORIASIS RECEIVING USTEKINUMAB MAINTENANCE THERAPY- LONG TERM RESULTS FROM PHOENIX 1

Author(s)

Leonardi C1, Papp K2, Schenkel B3, Zhao N3, Yeilding N4, Kimball A51St. Louis University, St. Louis, MO, USA, 2Probity Medical Research, Waterloo, ON, Canada, 3Johnson & Johnson Pharmaceutical Services, LLC, Horsham, PA, USA, 4Centocor Research & Development, Inc., Malvern, PA, USA, 5Harvard Medical School, Boston, MA, USA

OBJECTIVES: To assess the long-term impact of ustekinumab(UST) on quality of life(QoL) among patients responding to therapy at wk40. METHODS: In PHOENIX 1 psoriasis patients were randomized to UST45mg(n=255),UST90mg(n=256), or placebo(n=255). Placebo patients crossed over to receive UST45mg or 90mg at wk12.At wk40,UST PASI75 responders were re-randomized to continue the same dose of UST q12 wks or be withdrawn from treatment.After losing 50% of the improvement gained while on UST,patients withdrawn from treatment re-initiated UST at the same dose previously received.The DLQI assessed skin disease-specific QoL(lower scores indicating better QoL) through 3yrs;change of >=5 points was defined as a clinically meaningful change and a score of 0/1 was defined as no negative effect on patient’s life. RESULTS: 162 patients were re-randomized to UST at wk40(n=77,45mg;n=85,90mg);320 patients were withdrawn from UST at wk40 (n=141,45mg; n=179,90mg).Among patients re-randomized to UST, mean change from baseline in DLQI score for the 45mg and 90mg groups [mean(SD)] was:-9.1(7.0) and -10.0(6.1) at wk76 and -8.6(6.9) and -9.7(6.2) at Year3,respectively.Among patients withdrawn, mean change from baseline in DLQI score for the UST45mg and 90mg groups [mean(SD)] was: -1.4(5.8) and -4.2(4.7) at wk76 and 0.9(2.2) and -2.8(0.9) at Year3, respectively.At wk76 and Year3, 64.0% and 74.7%, and 64.6% and 65.4% of patients in the 45mg and 90mg groups,respectively,achieved a DLQI score of 0/1; at wks76 and Year3, 10.9% and 19.2%, and 3.1% and 13.9%,of patients withdrawn from 45mg and 90mg,respectively,achieved these results.In those re-randomized to UST, the proportion of patients in the 45mg and 90mg groups who experienced a ≥5 point improvement in DLQI was 73.3% and 78.5% at wk76, and 70.8% and 78.2% at Year3; in the withdrawal group, 19.6% and 20.9%, and 0.78% and 1.3%,of patients from 45mg and 90mg, respectively,achieved this result. CONCLUSIONS: Clinically meaningful QoL improvements are sustained through Year3 among patients responding at wk40 who continued to receive UST q12wks.

Conference/Value in Health Info

2010-05, ISPOR 2010, Atlanta, GA, USA

Value in Health, Vol. 13, No. 3 (May 2010)

Code

PSS16

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Sensory System Disorders

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