Luis Puig1,2,3,4, Baojin Zhu1,2,3,4, Russel Burge1,2,3,4, David Shrom1,2,3,4, Yan Dong1,2,3,4, Wei Shen1,2,3,4, Lotus Mallbris1,2,3,4, Kristian Reich1,2,3,4. 1. Dr. Puig is with Hospital de la Santa Creu i Sant Pau and Universitat Autonoma de Barcelona in Spain. 2. Drs. Zhu, Burge, Shrom, Dong, Shen, and Mallbris are with Eli Lilly and Company in Indianapolis, Indiana. 3. Dr. Burge is also with the University of Cincinnati in Cincinnati, Ohio. 4. Dr. Reich is with the Institute for Health Services Research in Dermatology and Nursing at the University Medical Center Hamburg-Eppendorf and Skinflammation® Center in Hamburg, Germany.
Abstract
BACKGROUND: Rapid improvements in health-related quality of life (HRQoL) and psoriasis severity have been reported in patients treated with ixekizumab (IXE), an interleukin (IL)-17A antibody. OBJECTIVE: We assessed the relationship between early Psoriasis Area and Severity Index (PASI) response and long-term Dermatology Life Quality Index (DLQI) improvement in patients in the randomized clinical trial IXORA-S (NCT0256186) treated with IXE or IL-12/23 (ustekinumab [UST]). METHODS: The proportion of patients achieving DLQI (0,1), an outcome equivalent to the patient's skin condition having no impact on HRQoL after 52 weeks of IXE or UST by PASI response at Weeks 4, 12, and 24 was quantified. Optimal thresholds for PASI response by treatment to predict Week 52 DLQI (0,1) were calculated based on Youden's Index. RESULTS: Early and higher levels of skin clearance were associated with improved patient outcomes regardless of treatment. Patients treated with IXE achieved faster and more pronounced PASI response than patients treated with UST. The optimal thresholds at Weeks 4, 12, and 24 for predicting DLQI (0,1) at Week 52 were ~PASI 75 for IXE versus ~PASI 50 for UST at Week 4, PASI 90 for IXE versus PASI 75 for UST at Week 12, and ~PASI 100 for IXE versus ~PASI 90 for UST at Week 24. Among patients achieving these thresholds, the probability of achieving a DLQI (0,1) was significantly higher. CONCLUSION: Earlier and higher levels of skin clearance are associated with improved patient outcomes over the long term, regardless of treatment.
RCT Entities:
BACKGROUND: Rapid improvements in health-related quality of life (HRQoL) and psoriasis severity have been reported in patients treated with ixekizumab (IXE), an interleukin (IL)-17A antibody. OBJECTIVE: We assessed the relationship between early Psoriasis Area and Severity Index (PASI) response and long-term Dermatology Life Quality Index (DLQI) improvement in patients in the randomized clinical trial IXORA-S (NCT0256186) treated with IXE or IL-12/23 (ustekinumab [UST]). METHODS: The proportion of patients achieving DLQI (0,1), an outcome equivalent to the patient's skin condition having no impact on HRQoL after 52 weeks of IXE or UST by PASI response at Weeks 4, 12, and 24 was quantified. Optimal thresholds for PASI response by treatment to predict Week 52 DLQI (0,1) were calculated based on Youden's Index. RESULTS: Early and higher levels of skin clearance were associated with improved patient outcomes regardless of treatment. Patients treated with IXE achieved faster and more pronounced PASI response than patients treated with UST. The optimal thresholds at Weeks 4, 12, and 24 for predicting DLQI (0,1) at Week 52 were ~PASI 75 for IXE versus ~PASI 50 for UST at Week 4, PASI 90 for IXE versus PASI 75 for UST at Week 12, and ~PASI 100 for IXE versus ~PASI 90 for UST at Week 24. Among patients achieving these thresholds, the probability of achieving a DLQI (0,1) was significantly higher. CONCLUSION: Earlier and higher levels of skin clearance are associated with improved patient outcomes over the long term, regardless of treatment.
Authors: Christine Blome; Ramona Gosau; Marc A Radtke; Kristian Reich; Stephan J Rustenbach; Christina Spehr; Diamant Thaçi; Matthias Augustin Journal: Arch Dermatol Res Date: 2015-12-19 Impact factor: 3.017
Authors: K Reich; A Pinter; J P Lacour; C Ferrandiz; G Micali; L E French; M Lomaga; Y Dutronc; C Henneges; S Wilhelm; S Hartz; C Paul Journal: Br J Dermatol Date: 2017-07-19 Impact factor: 9.302
Authors: Christopher E M Griffiths; Kristian Reich; Mark Lebwohl; Peter van de Kerkhof; Carle Paul; Alan Menter; Gregory S Cameron; Janelle Erickson; Lu Zhang; Roberta J Secrest; Susan Ball; Daniel K Braun; Olawale O Osuntokun; Michael P Heffernan; Brian J Nickoloff; Kim Papp Journal: Lancet Date: 2015-06-10 Impact factor: 79.321
Authors: C L Leonardi; A Blauvelt; H L Sofen; M Gooderham; M Augustin; R Burge; B Zhu; K Reich Journal: J Eur Acad Dermatol Venereol Date: 2017-06-28 Impact factor: 6.166
Authors: Kenneth B Gordon; Keith A Betts; Murali Sundaram; James E Signorovitch; Junlong Li; Meng Xie; Eric Q Wu; Martin M Okun Journal: J Am Acad Dermatol Date: 2017-10-06 Impact factor: 11.527
Authors: B Zhu; E Edson-Heredia; G S Cameron; W Shen; J Erickson; D Shrom; P Wang; S Banerjee; K B Gordon Journal: Br J Dermatol Date: 2013-12 Impact factor: 9.302
Authors: Dennis A Revicki; Mary K Willian; Alan Menter; Jean-Hilaire Saurat; Neesha Harnam; Martin Kaul Journal: Dermatology Date: 2008-01-11 Impact factor: 5.366