54 5 th World Psoriasis & Psoriatic Arthritis Conference 2018
P132 MIRIKIZUMAB SIGNIFICANTLY IMPROVES SELF- REPORTED DISEASE SEVERITY AND GENERAL HEALTH STATUS IN PATIENTS WITH MODERATE-TO-
SEVERE PSORIASIS Melinda Gooderham 1, Paul Klekotka 2, Emily Edson Heredia 2, Joanne Li 2, Baojin Zhu 2, Jiaying Guo 2, Jerry Bagel 3
1
SKiN Centre for Dermatology, 2 Eli Lilly & Company, 3 Windsor Dermatology
Introduction: In a randomized, placebo-controlled, phase 2 trial( NCT02899988), mirikizumab met its primary efficacy endpoint at Week 16.1 Objective: To determine if mirikizumab improves patient-reported disease severity and general health status in psoriasis patients at Week 16. Methods: Adults with moderate-to-severe psoriasis were randomized 1:1:1:1 to receive placebo( n = 52), mirikizumab 30 mg( n = 51), 100 mg( n = 51), or 300 mg( n = 51) at Weeks 0 and 8. At baseline and Weeks 2, 4, 8, 12, and 16, patients completed the Patient Global Assessment of psoriasis( PtGA)( 0 = clear, 5 = severe). At baseline and Week 16, patients completed the Medical Outcomes Study 36-Item Short Form Health Survey( SF-36; [ range 0 – 100 ]) which measures 8 general health status domains that can be scored as mental component and physical component summaries. For continuous measures, comparisons were made by a mixed-effects for repeated measures model( PtGA) or an analysis of covariance model( SF-36). Comparisons of categorical efficacy variables were conducted by logistic regression analysis with non-responder imputation( NRI). Results: At Week 16, mirikizumab-treated patients reported greater improvements in psoriasis severity and aspects of physical functioning versus placebo( Table). Conclusion: Mirikizumab treatment at various doses significantly improved psoriatic disease severity and physical health status. Reference: 1. Reich K et al. Programme and abstracts of Psoriasis from Gene to Clinic; Nov. 30-Dec. 2, 2017; Abstract FC31. Table. Patient-Reported Outcomes( Week 16)
Mirikizumab Placebo 30 mg 100 mg 300 mg n = 51 n = 48 n = 51 n = 51
PtGA, least squares mean( SE) |
0.4( 0.16) |
2.2( 0.16)*** 2.9( 0.16)*** 2.8( 0.16)*** |
Change from Baseline in SF-36 Domains, LSM( SE) |
Physical functioning |
2.8( 1.9) |
7.2( 2.0) |
8.2( 1.9)* |
7.2( 2.0) |
Role-physical |
1.2( 2.4) |
11.4( 2.5)** |
11.5( 2.5)** |
12.3( 2.5)** |
Bodily pain |
5.7( 2.8) |
17.6( 2.9)** |
19.2( 2.9)*** 18.9( 2.9)** |
General health |
1.4( 1.9) |
5.8( 2.0) |
3.2( 1.9) |
5.4( 1.9) |
Vitality |
1.0( 2.0) |
6.9( 2.1)* |
4.7( 2.0) |
6.2( 2.0) |
Social functioning |
-0.2( 2.4) |
10.5( 2.4)** |
13.4( 2.4)*** 8.2( 2.4)* |
Role-emotional |
1.3( 2.0) |
5.2( 2.1) |
6.1( 2.0) |
6.0( 2.0) |
Mental health |
1.7( 1.8) |
5.5( 1.8) |
6.6( 1.8) |
3.2( 1.8) |
≥2.5 point improvement in SF-36 |
36.5 |
37.3 |
45.1 |
33.3 |
MCS, %( NRI) |
|
|
|
|
≥2.5 point improvement in SF-36 PCS, %( NRI) |
42.3 |
52.9 |
56.9 |
62.7 * |
MCS, mental component summary; PtGa, Patient Global Assessment; PCS, physical component |
summary; SE, standard error; SF-36, 36-Item Short Form Health Survey. |
* p <. 05 vs placebo; ** p <. 01 vs placebo; *** p <. 001 vs placebo. |
P133 EFFECT OF TILDRAKIZUMAB ON PERSONAL RELATIONSHIPS IN PATIENTS WITH MODERATE-TO-
SEVERE CHRONIC PLAQUE PSORIASIS Kim Papp 1, Alexa Kimball 2, Andrew Blauvelt 3, Kristian Reich 4, Melinda Gooderham 5, Stephen Tyring 6, Rodney Sinclair 7, Diamant Thaci 8, Yang Zhao 9, Nicole Cichanowitz 10, Qing Li 10, Carmen La
Rosa 10 1
K Papp Clinical Research and Probity Medical Research, Waterloo, Ontario, Canada, 2 Harvard Medical School, Boston, MA, 3 Oregon Medical Research Center, Portland, OR, USA, 4 ScIderm Research Institute and Dermatologikum Hamburg, Hamburg, Germany, 5 SKiN Centre for Dermatology and Probity Medical Research, Peterborough, and Queen’ s University, Kingston, Ontario, Canada, 6 Department of Dermatology, University of Texas, Houston, TX, USA, 7 University of Melbourne, Melbourne, VIC,
Australia, 8 University of Lübeck, Lübeck, Germany, 9 Sun Pharmaceutical Industries, Inc., Princeton, NJ, 10 Merck & Co., Inc., Kenilworth, NJ, USA
Introduction: The negative impact of psoriasis extends beyond the patient, affecting his / her social interactions and the quality of life of cohabitants. Furthermore, patients with psoriasis often experience sexual difficulties because of their disease. Objective: This analysis examined the effect of treatment with tildrakizumab( TIL) on personal relationships of patients with moderate-to-severe chronic plaque psoriasis. Methods: Patients in two phase 3 trials reSURFACE 1( NCT01722331) and reSURFACE 2( NCT01729754) were randomized to subcutaneous TIL 200 mg, 100 mg, or placebo( PBO) and received treatment at weeks 0 and 4. PBO patients were re-randomized at week 12 to either TIL 200 mg or 100 mg. Etanercept( ETN) 50 mg( semiweekly until week 12 then weekly until week 28) was also a treatment arm in reSURFACE 2. Data on personal relationships were collected at weeks 12 and 28 from the Dermatology Life Quality Index( DLQI) questionnaire question 8( Q8)“ Over the last week, how much has your skin created problems with your partner or any of your close friends or relatives” and question 9( Q9)“ Over the last week, how much has your skin caused any sexual difficulties”. Each question was scored on a scale of 0( not affected at all) to 3( very much affected). The data were pooled from reSURFACE 1 and 2. Results: In all, 1,820 patients had DLQI data. All patients reported a negative effect for Q8 and Q9 at baseline. At week 12, the proportion of patients with no negative effect( score of 0) on personal relationships( Q8 and Q9) was higher for TIL 200 mg, TIL 100 mg, and ETN than for PBO( 76 %, 72 %, and 64 % vs. 39 %, respectively). A similar trend was observed for individual questions Q8 and Q9. At week 28, more patients on TIL 200 mg and TIL 100 mg reported no negative effect on personal relationships than those on ETN( 85 % and 77 % vs. 66 %; respectively). More patients on TIL 200 mg and TIL 100 mg reported no negative effect than those on ETN for Q8( 89 % and 81 % vs. 70 %; respectively) and for Q9( 89 % and 84 % vs. 75 %, respectively). Conclusions: TIL had a beneficial effect on psoriasis-related personal relationship problems and sexual difficulties, compared to placebo and ETN. This abstract was presented at 2018 Annual Meeting of American Academy of Dermatology.
P134 PRURITUS SEVERITY ASSESSMENT AND CORRELATION WITH BASELINE CHARACTERISTICS OF PATIENTS WITH PSORIASIS VULGARIS: AN EXPLORATORY ANALYSIS OF THE PHASE IIIB,
PSORITUS STUDY Sonja Ständer 1, Sabine Steinke 1, Matthias Augustin 2, Dieter Metze 1, Karin Loser 1, Daniel Baeumer 3, Thomas Luger 4
1
Department of Dermatology and Competence Center Chronic Pruritus and 4 Department of Dermatology, University hospital Münster, Münster,
2
Institute for Health Services Research in Dermatology and Nursing, Hamburg, and 3 Novartis Pharma, Nuernberg, Germany
Introduction: Chronic pruritus lasts for at least 6 weeks and is a most common symptom in patients with psoriasis. Pruritus is a highly prevalent and troublesome symptom and has a negative impact upon patients’ health-related quality of life( QoL). The ItchyQoL is a pruritus-specific QoL questionnaire that can be applied to patients with pruritus independent of the underlying disease. Objective: To assess the impact of pruritus on QoL in patients with psoriasis by an exploratory analysis of baseline characteristics of subjects from the PSORITUS study. Methods: PSORITUS was an exploratory, randomized, doubleblind, placebo-controlled 16-week drug withdrawal study with a 16-week open-label run-in phase, to assess the kinetics of psoriasis symptoms, pruritus intensity, and lesional biomarkers. Subjects www. medicaljournals. se / acta