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5 th World Psoriasis & Psoriatic Arthritis Conference 2018
Introduction: Ixekizumab, a high-affinity monoclonal antibody that selectively targets IL-17A, was shown to be superior to ustekinumab, an IL-12 / 23 inhibitor, with respect to skin clearance and quality of life up to 24 wks in patients with moderate-to-severe psoriasis in IXORA-S1. Objectives: The objective of this analysis was to compare the cumulative benefits of ixekizumab versus ustekinumab at 12 and 24 weeks of treatment in IXORA-S, with respect to skin clearance, itching, health-related quality of life( HRQoL), and pain. Methods: In the IXORA-S trial, patients were randomized( 1:1) to receive either IXE( 160-mg starting dose, then 80-mg every 2 wks for 12 wks followed by 80-mg every 4 wks; n = 136) or UST( 45 – mg / 90-mg weight-based dosing per label; n = 166) through 52 wks. Data at week 12 and week 24 were used in this post-hoc analysis. At wks 2, 4, and every 4 wks thereafter, clinical benefits were measured using percentage improvements in Psoriasis Area and Severity Index( PASI 75 / 90 / 100); the Itch Numeric Rating Scale( NRS; 0 = no itch, 10 = worst itch imaginable); and Skin Pain VAS( 0 = no pain, 100 = maximum pain). Health-related quality of life( HRQoL) benefit was measured at wks 2, 4, 12, and 24 using the Dermatology Life Quality Index( DLQI) [ DLQI score = 0.1 indicates no effect on patient’ s life ]. Total benefits- PASI 75 / 90 / 100; itch NRS = 0; DLQI = 0.1; Pain VAS 0 – were used to determine the area-under-the-curve( AUC) of responders for each outcome at 12 and 24 weeks. Missing values were imputed using non-responder imputation( NRI). AUC results, capturing the rapid and sustained treatment response, were normalized as a percentage of maximum possible( 0 – 100 %) AUC. The clinical benefit ratios between IXE vs UST were calculated for each outcome to show relative cumulative benefit. Results: At 12 wks, the normalized cumulative clinical benefit with IXE vs UST, respectively, was 58.2 % and 32.9 %( PASI75); 36.7 % and 15.6 %( PASI90); 14.2 % and 4.0 %( PASI100); 25.3 % and 14.3 %( itch); 36.0 % and 23.7 %( pain); and 44.9 % and 25.2 %( DLQI). Cumulative clinical benefits at week 24 for IXE and UST, respectively, were 74.3 % and 54.3 %( PASI75), 58.1 % and 32.3 %( PASI90), 29.0 % and 12.2 %( PASI100); 33.5 % and 22.1 %( itch); 42.7 % and 30.6 %( pain); and 54.3 % and 37.0 %( DLQI). At 12 wks, clinical benefit ratios( IXE / UST) for PASI 75 / 90 / 100 were 1.77, 2.36, and 3.52; 1.51 for pain; and 1.78 for both itch and DLQI. At 24 wks, the ratios were 1.37, 1.80, 2.38( PASI 75 / 90 / 100), 1.52( itch), 1.39( pain) and 1.47( DLQI). Conclusions: Cumulative benefits measured by PASI, itch, pain, and DLQI responders were greater for IXE vs. UST following 12 and 24 wks of treatment. Long-term cumulative benefits will be addressed upon publication of Week 52 results from the IXORA-S trial. Reference: Reich K, et al. Br J Dermatol. 2017; 177( 4): 1014-1023. Previously presented at AAD, San Diego, CA; February 16 – 20, 2018.
P138 COACH @ HOME: A SUPPORT PROGRAM FOR
PATIENTS TREATED WITH CERTOLIZUMAB PEGOL Nicolai Böhme 1, Ann-Dörthe Holst 2, Friedrich Dybowski 3, Christoph Volberg 4, Hans-Georg Pott 5, Udo Lendl 6
1
Healthcare at Home Deutschland GmbH, Weinheim, 2 Rheumapraxis, Ludwigslust, 3 Rheumapraxis Ruhr, Herne, 4 Rheumatologie in Neuss, Neuss,
5
Rheumatologikum Hannover, Hannover, 6 UCB Pharma GmbH, Monheim am Rhein, Germany
Introduction: Coach @ home( c @ h) is a German support program for certolizumab pegol( CZP)-treated patients( pts) with rheumatic diseases, including psoriatic arthritis( PsA). Eight coaching calls are offered over one year, scheduled around critical milestones on the therapeutic journey. These are made by trained nurses, who offer support and information about both the pt’ s disease and its treatment with CZP.
Objectives: To assess the baseline characteristics of PsA pts subscribed to c @ h, and the level of pt satisfaction with the program across indications( Sep 2017 data cut). Methods: c @ h was launched in Jun 2014, and is available to pts who are prescribed CZP according to the local product label. Pts must be CZP-naïve when subscribed to the program, and pt consent is required prior to subscription by the treating physician. There are no additional criteria for enrolment, although the program must be recommended to the pt by the treating physician. Pt satisfaction across indications( PsA, rheumatoid arthritis and axial spondyloarthritis) was measured at program completion or discontinuation using the net promoter score( NPS), which has previously been used for this purpose. 1 The NPS is derived by asking pts to state the likelihood that they would recommend c @ h to others( on a 0 – 10 scale). Rankings of 9 – 10 are considered‘ promoters’, 7 – 8‘ passives’, and 0 – 6‘ detractors’. Subtracting the percentage of detractors from that of promoters yields the NPS. Results: A cumulative total of 136 PsA pts had been registered to c @ h by Sep 2017. Mean age at baseline was 52 years; the majority were female( 69 %). Prior biological DMARD exposure was 24 %. The most common topics discussed on calls were treatment adherence( 290 calls), CZP maintenance dose( 284 calls) and syringe disposal( 201 calls). The average length per call was 15.7 min( SD: 5.33) at the end of Week 0( total: 135 calls), and 14.6 min( SD: 6.59) at the end of Week 52( 45 calls). Across indications, a cumulative total of 272 / 655 pts had either completed the coaching period( n = 70) or discontinued( n = 202) by 28 Sep 2017, of whom 106 rated the program. Of these, 87.5 % gave promoter scores, 10.4 % passive, and 3.8 % detractor, yielding an NPS of 83.7. The program was still ongoing at the time of this data cut. Conclusions: c @ h offers support and guidance to CZP-treated pts in Germany. Feedback from pts willing to provide a rating( 39 %) indicates a high level of satisfaction with the program. References: 1. Hamilton DF. Bone Joint J 2014; 96-B( 5): 622 – 8. Acknowledgements: c @ h is performed by Healthcare @ home Deutschland GmbH, funded by UCB Pharma, led by Elke Zeise and managed by Karen Thiel and Manh Dan Nguyen. We thank the patients and their caregivers in addition to the investigators and their teams who contributed to this program. Editorial services were provided by Costello Medical.
P139 A COMPREHENSIVE SURVEY ASSESSING THE FAMILY
PLANNING NEEDS OF WOMEN WITH PSORIASIS Mark Lebwohl 1, Abby S Van Voorhees 2, Michael Siegel 3, Lindsey Shankle 3, Lisa Pisenti 4, Mohamed Yassine 4
1
Icahn School of Medicine at Mount Sinai, New York, NY, 2 Eastern Virginia Medical School, Norfolk, VA, 3 National Psoriasis Foundation, Portland, OR, 4 UCB Pharma, Smyrna, GA, USA
Introduction: Psoriasis( PS) in women often overlaps with their peak reproductive years. Data on the family planning( FP) experience of patients( pts) are therefore needed to optimize PS management. Objectives: To report the results of a survey evaluating the FP needs of women with PS. Methods: Women of childbearing potential( WoCP; aged 18 – 45) diagnosed with PS( including pts with psoriatic arthritis), were recruited to complete a 96-question web-based survey on SurveyGizmo ®. The survey included questions on pts’ experience, concerns and educational needs, and was disseminated using e- blasts( the National Psoriasis Foundation, Advance E-News, and TalkPsoriasis. org mailing lists) and social media( Facebook and Twitter). Responses were collected Dec 2017 – Feb 2018. Results: Of 141 pts completing the survey, 91( 65 %) were planning to conceive( PTC), and 66( 47 %) had experienced pregnancy( EP) within the last 5 years. Prescribed systemic medications were www. medicaljournals. se / acta