A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

— SPIRIT-H2H  

Official title:

A 52-Week Multicenter, Randomized, Open-Label, Parallel- Group Study Evaluating the Efficacy and Safety of Ixekizumab Versus Adalimumab in Patients With Psoriatic Arthritis Who Are Biologic Disease-Modifying Anti-Rheumatic Drug Naive

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03151551
• Other study ID #: 16687
• Secondary ID: I1F-MC-RHCF2016-
• Status: Completed
• Phase: Phase 4
• Start date: August 24, 2017
• Est. completion date: September 4, 2019

Study information

• Verified date: September 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drugs (DMARD) naive.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 566
• Est. completion date: September 4, 2019
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Presence of established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria

• Active PsA defined as the presence of at least 3 (out of 68) tender and at least 3 (out of 66) swollen joints

• Presence of active plaque psoriasis with a BSA =3%

• Men must agree to use a reliable method of birth control or remain abstinent during the study

• Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

• Have had an inadequate response when treated with 1 or more conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)

Exclusion Criteria:

• Current or prior use of biologic agents for treatment of Ps or PsA

• Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA

• Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab

• Serious disorder or illness other than psoriatic arthritis

• Serious infection within the last 3 months

• Active Crohn's disease or active ulcerative colitis

• Active vasculitis or uveitis

• Diagnosis of or history of malignant disease <5 years prior to randomization

• Women who are breastfeeding

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• Ixekizumab
Administered SC
• Adalimumab
Administered SC

Locations

Country	Name	City	State
Argentina	Atencion Integral en Reumatología	Ciudad Autonoma de Buenos Aire	Buenos Aires
Argentina	Centro de Medicina Familiar Mindout Research	Ciudad Autonoma de Buenos Aire
Argentina	CENUDIAB	Ciudad Autonoma de Buenos Aire
Argentina	Hospital Ramos Mejia	Ciudad Autonoma de Buenos Aire
Argentina	Instituto Centenario	Ciudad Autonoma de Buenos Aire
Argentina	Organizacion Medica de Investigacion - OMI	Ciudad Autonoma de Buenos Aire
Argentina	Clinica Adventista de Belgrano	Ciudad de Buenos Aires	Buenos Aires
Argentina	Consultora Integral de Salud S.R.L.	Cordoba
Argentina	CER Instituto Medico	Quilmes	Buenos Aires
Argentina	Instituto de Asist Reumatologica Integral	San Fernando	Buenos Aires
Argentina	Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan	San Juan
Argentina	Centro Medico Privado de Reumatologia	San Miguel de Tucuman	Tucuman
Australia	Emeritus Research	Camberwell	Victoria
Australia	St Vincents Hospital Melbourne	Fitzroy	Victoria
Australia	Southern Clinical Research Pty Ltd	Hobart	Tasmania
Australia	Combined Rheumatology Practice (CRP)	Kogarah	New South Wales
Australia	Rheumatology, The Queen Elizabeth Hospital	Woodville South	South Australia
Austria	AKH	Wien
Austria	Rheuma-Zentrum Wien Oberlaa	Wien
Austria	Zentrum für klinische Studien Dr. Ursula Hanusch GmbH	Wien
Belgium	Reumaclinic	Genk
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Saint Joseph Hospital	Gilly
Belgium	Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg	Leuven
Belgium	Hopital Ambroise Pare	Mons
Canada	The Waterside Clinic	Barrie	Ontario
Canada	SKiN Center for Dermatology	Peterborough	Ontario
Canada	Group de recherche en maladies osseuses	Quebec
Canada	Polmed Research Inc.	Saskatoon	Saskatchewan
Canada	Centre de Recherche Musculo-Squelettique	Trois-Rivieres	Quebec
Denmark	Aalborg Universitetshospital - Psykiatrien	Aalborg
Denmark	Frederiksberg Hospital	Frederiksberg	Hovedstaden
Finland	Helsinki University Hospital, HYKS	Helsinki
Finland	Kiljava Medical Research	Hyvinkaa
Finland	Terveystalo Kouvola	Kouvola
Finland	Turun Yliopistollinen Keskussairaala	Turku
France	Hôpital Trousseau, CHRU de Tours	Chambray-lès-Tours
France	Centre Hospitalier de Vendee Les Oudairies	La Roche Sur Yon
France	Hopital Edouard Herriot	Lyon Cedex 03
France	Centre hospitalier universitaire Lapeyronie	Montpellier Cedex 5
France	Nouvel Hôpital Orléans La Source	Orleans CEDEX 2
France	Hôpital Pierre-Paul Riquet	Toulouse cedex 9
Germany	Klinikum der Johann Wolfgang Goethe-Universität Frankfurt	Frankfurt am Main	Hessen
Germany	HRF Hamburger Rheuma Forschungszentrum	Hamburg
Germany	Klinikum der Universität München	München	Bayern
Germany	Rheumazentrum Ratingen	Ratingen	Nordrhein-Westfalen
Hungary	Obudai Egeszsegugyi Centrum Kft	Budapest
Hungary	UNO Medical Trials Kft.	Budapest
Hungary	Allergo-Derm Bakos Kft	Szolnok	Jasz-Nagykun-Szolnok
Hungary	Vital Medical Center	Veszprem
India	Byramjee Jeejeebhoy Medical College & Civil Hospital	Ahmedabad	Gujarat
India	Panchshil Hospital	Ahmedabad	Gujarat
India	Shalby Hospital	Ahmedabad	Gujarat
India	Narayana Hrudayalaya Hospital	Bangalore	Karnataka
India	Artemis Hospital	Gurgaon	Haryana
India	Care Hospital	Hyderabad	Andhra Pradesh
India	Apollo Gleneagles Hospitals	Kolkata	West Bengal
India	Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.	Mumbai	Maharashtra
India	Sir Ganga Ram Hospital	New Delhi	Delhi
India	Ruby Hall Clinic and Grant Medical Foundation	Pune	Maharashtra
India	Krishna Institute of Medical Sciences Ltd.	Secunderabad	Telengana
India	Government Medical College & Sir Sayajirao General Hospital	Vadodara	Gujarat
India	King George Hospital	Visakhapatnam	Andhra Pradesh
Israel	Barzilai Medical Center	Ashkelon
Israel	Carmel Medical Center	Haifa
Israel	Rambam Medical Center	Haifa
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center	Petach Tikva
Israel	Sheba Medical Center	Ramat Gan
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Israel	Assaf Harofeh Medical Center	Zerifin
Italy	Istituto Ortopedico Rizzoli	Bologna
Italy	Presidio Ospedaliero Vittorio Emanuele	Catania
Italy	Fondazione Universitaria degli Studi G D'Annunzio	Chieti
Italy	Complesso Integrato Columbus	Roma
Italy	Policlinico di Tor Vergata	Roma
Italy	Istituto Clinico Humanitas	Rozzano	Milano
Italy	Ospedale Policlinico Giambattista Rossi, Borgo Roma	Verona
Mexico	Centro Investigacion de Tratam Innovadores de Sinaloa SC	Culiacan	Sinaloa
Mexico	RM Pharma Specialists S.A. de C.V.	Distrito Federal
Mexico	Cemdeicy S.C.P.	Merida	Yucatán
Mexico	Centro Medico del Angel S.C.	Mexicali	Baja California
Mexico	Ctro Inv en Artritis y Osteoporosis SC	Mexicali	Baja California
Mexico	Grupo Médico CAMINO S.C.	México City	Distrito Federal
Mexico	Clínica Enfermedades Crónicas y Procedimientos Especiales SC	Morelia	Michoacan
Mexico	CIMAB S.A. de C.V.	Torreon	Coahuila
Netherlands	Antonius Ziekenhuis	Sneek
Poland	NZOZ Centrum Reumatologiczne Ind. Prak.	Elblag
Poland	"Dermed" Centrum Medyczne Sp. z o.o.	Lodz
Poland	Twoja Przychodnia-Centrum Medyczne Nowa Sol	Nowa Sol
Poland	Rheuma Medicus Zaklad Opieki Zdrowotnej	Warsaw
Poland	DermMEDICA Sp. z o.o.	Wroclaw
South Africa	St Augustines Hospital	Durban
South Africa	Suite 509 Umhlanga Netcare Medical Centre	Durban	KwaZulu-Natal
South Africa	Clinresco Centres (Pt) Ltd	Johannesburg	Gauteng
South Africa	Emmed Research	Muckleneuk
South Africa	Arthritis Clinical Research Trial Unit	Pinelands	Western Cape
South Africa	Greenacres Hospital	Port Elizabeth	Eastern Cape
South Africa	Prof Ally	Pretoria
South Africa	Suite 209A Jakaranda Hospital	Pretoria
South Africa	Winelands Medical Research Centre	Stellenbosch	Western Cape
Spain	Hospital Del Sagrado Coraz	Barcelona
Spain	Complexo Hospitalario Universitario A Coruña, CHUAC	La Coruna
Spain	Hospital Marina Baixa	La Vila Joiosa	Alicante
Spain	Hospital Clinico Universitario de Santiago	Santiago de Compostela	La Coruna
Spain	Hospital Infanta Luisa	Sevilla
Sweden	Reumatologiska Kliniken Skånes universitetssjukhus Malmö	Malmo
Sweden	Centrum för reumatologi	Stockholm
Sweden	Reumatologiska Kliniken Karolinska Universitetssjukhuset Solna	Stockholm
Sweden	Reumatologikliniken Västmanlands Sjukhus	Västerås	Västmanland
Switzerland	HUG-Hôpitaux Universitaires de Genève	Genève
Switzerland	Kantonsspital St. Gallen	St. Gallen	Sankt Gallen
Ukraine	Regional Clinical Hospital Center for Emergency medical care	Kharkiv
Ukraine	Kyiv City Clinical Hospital #3	Kyiv
Ukraine	National Scientific Center "Strazhesko institute of cardio"	Kyiv
Ukraine	Multifield Medical Center of Odesa NMU (University Clinic#1)	Odesa
Ukraine	Municipal Institution of Ternopil Regional Council	Ternopil
Ukraine	Vinnytsya Regional Clinical Hospital	Vinnytsya
Ukraine	Regional Clinical Hospital of Zaporizhzhia	Zaporizhzhia
United Kingdom	St Lukes Hospital	Bradford	West Yorkshire
United Kingdom	Addenbrookes Hospital	Cambridge	Cambridgeshire
United Kingdom	The Dudley Group NHS Foundation Trust	Dudley	West Midlands
United Kingdom	Western General Hospital	Edinburgh	Scotland
United Kingdom	Whipps Cross University Hospital	London	Surrey
United Kingdom	North Tyneside General Hospital	North Shields	Tyneside
United Kingdom	Southampton General Hospital	Southampton	Hants
United Kingdom	The Great Western Hospital	Swindon	Wiltshire
United Kingdom	Royal Cornwall Hospital	Truro	Cornwall
United Kingdom	Wishaw General Hospital	Wishaw	North Lanarkshire
United Kingdom	New Cross Hospital	Wolverhampton	West Midlands
United Kingdom	Wythenshawe Hospital	Wythenshawe	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Belgium,  Canada,  Denmark,  Finland,  France,  Germany,  Hungary,  India,  Israel,  Italy,  Mexico,  Netherlands,  Poland,  South Africa,  Spain,  Sweden,  Switzerland,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in Tender Joint Count (TJC)	TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model that included treatment group, concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.	Baseline, Week 52
Other	Change From Baseline in Swollen Joint Count (SJC)	SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using MMRM model that included treatment group, concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.	Baseline, Week 52
Other	Change From Baseline in Participant's Assessment of Pain Visual Analogue Score (VAS)	The pain VAS is a participant-administered single-item scale designed to measure current joint pain from Psoriatic arthritis (PsA) using a 100-millimeter(mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by marking a vertical tick on the horizontal 100-mm scale, where the left end from 0 mm (no pain) to right end 100 mm (worst possible joint pain). LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.	Baseline, Week 52
Other	Change From Baseline in Participant's Global Assessment of Disease Activity	The patient's overall assessment of his or her PsA activity was recorded using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.	Baseline, Week 52
Other	Change From Baseline in Physician's Global Assessment of Disease Activity	The investigator was asked to give an overall assessment of the severity of the participant's current PsA activity using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.	Baseline, Week 52
Other	Change From Baseline in C-Reactive Protein (CRP)	CRP is the ACR Core Set laboratory measure of acute-phase reactant. It was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on the participant's PsA. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.	Baseline, Week 52
Other	Change From Baseline in HAQ-DI	HAQ-DI is a participant reported questionnaire that measures disease-associated disability (physical function). It consists of 24 questions with 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities. The disability section scores the participant's self-perception on the degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), covering the 8 domains. The reported use of special aids or devices and/or the need for assistance of another person to perform these activities is assessed. The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.	Baseline, Week 52
Other	Percentage of Participants Simultaneously Achieving ACR50 and PASI100	ACR50 response is a =50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of VAS, Pts Global Assessment of Disease Activity (PatGA) VAS, Physician's Global Assessment of Disease Activity (PGA)VAS, participant assessment of physical function using the HAQ-DI, or High Sensitivity(assay) C-Reactive Protein (hs-CRP). PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Participant achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Pts achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Pts with active plaque PsO with a BSA=3% & PASI=0 at baseline were considered PASI100 responders if they had achieved PASI=0 & BSA=0 at week 52.	Week 52
Other	Change From Baseline in Disease Activity Score-CRP (DAS28-CRP)	The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP (measured in milligrams per liter), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.	Baseline, Week 52
Other	Percentage of Participants Achieving Minimal Disease Activity (MDA)	MDA is a composite of 7 key outcome measures: TJC =1; SJC =1; psoriasis activity and severity index (PASI total score) =1 or BSA =3; participant pain VAS score of =15; participant global disease activity VAS score of =20; HAQ-DI score =0.5; and tender entheseal points =1. Participants are classified as achieving MDA if they fulfill 5 of 7 outcome measures.	Week 52
Other	Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)	The PsARC is a composite criteria reported in terms of the percentage of participants achieving response according to the following criterion: TJC, SJC, PGA, and PatGA. Overall response is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria: at least 30% reduction in TJC, at least 30% reduction in SJC, at least a 20 millimeter (mm) reduction in PGA and at least a 20 mm reduction in PatGA.	Week 52
Other	Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score	The CPDAI is a validated instrument intended to assess composite psoriatic disease activity and response to therapy. Domains include peripheral arthritis as assessed by the number of tender and swollen joints and the HAQ-DI, skin as assessed by the PASI and the Dermatology Life Quality Index (DLQI), enthesitis as assessed by the number of sites with enthesitis and the HAQ-DI, and dactylitis as assessed by the number of digits affected. Each domain with the exception of spinal disease is scored from 0-3. Individual domain scores are summed to give an overall composite score (range 0-12) with a higher score indicating higher disease activity. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.	Baseline, Week 52
Other	Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants With Enthesitis at Baseline	The SPARCC enthesitis index evaluates tenderness in a total of 16 entheseal sites: the greater trochanter (right/left [R/L]), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial epicondyles of humerus (R/L),Lateral epicondyle humerus (R/L) and the supraspinatus insertion (R/L). Tenderness at each site is quantified on a dichotomous basis: 0 = nontender and 1 = tender. The results from each site are then added to produce a total score (range 0 to 16) with the Higher scores indicating more severe enthesitis. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.	Baseline, Week 52
Other	Change From Baseline in the Leeds Enthesitis Index (LEI) in Participants With Enthesitis at Baseline	The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle of humerus, right/left (R/L); medial femoral condyle,(R/L); Achilles tendon insertion, (R/L)). Each site is assigned a score of 0 (absent) or 1 (present); the results from each site are then added to produce a total score (range 0 to 6) with the higher scores indicating more severe enthesitis. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.	Baseline, Week 52
Other	Change From Baseline in the Leeds Dactylitis Index-Basic (LDI-B) in Participants With Dactylitis at Baseline	The LDI-B measures the severity of dactylitis.In each digit,the ratio of the circumference(cf) of the affected digit to the cf of the digit on the opposite hand or foot measured in mm. Each dactylitic digit is defined by a minimum increase of 10% in cf over the contra-lateral digit.If the same digits on each hand or foot were thought to be involved,the clinician referred to a table of normative values for a value which was used to provide the comparison.If the ratio is >1.1,then subtract 1 from the calculated ratio and multiply it by 100 and the tenderness score of 0(not tender) or 1(tender).Otherwise,if the ratio of the cf of the digit is =1.1,then the LDI-B score is set to 0.LDI-B score can be >=0 with higher numbers indicating worse dactylitis.LS mean was calculated using MMRM model: treatment group,concomitant csDMARD use at baseline,moderate-to-severe Ps involvement,visit as fixed factors,baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.	Baseline, Week 52
Other	Change From Baseline in Psoriasis Body Surface Area (BSA)	The investigator evaluates the percentage involvement of psoriasis on each participant's BSA on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.	Baseline, Week 52
Other	Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Fingernails Score in the Subgroup of Participants With Fingernail Involvement at Baseline	The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis). LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.	Baseline, Week 52
Other	Change From Baseline in the Itch NRS	The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from psoriasis is indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.	Baseline, Week 52
Other	Change From Baseline in Fatigue Severity NRS (Fatigue NRS) Score	The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine." Participants rate their fatigue (weariness, tiredness) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.	Baseline, Week 52
Other	Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS)	The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.	Baseline, Week 52
Other	Change From Baseline in SF-36: Mental Component Summary (MCS)	The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.	Baseline, Week 52
Other	Change From Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) United Kingdom(UK) Population-Based Index Score	The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The descriptive part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.The EQ-5D-5L health states were converted into a single summary index by applying a crosswalk using a UK Population value set to each of the levels in each dimension.This produced participant-level index scores between -0.594 and 1.0 (worse to better health). LS mean was calculated using MMRM model that included treatment group,concomitant csDMARD use at baseline,moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.	Baseline, Week 52
Other	Change From Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L]) VAS Score	EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (worst health you can imagine) to 100mm VAS (best health you can imagine). LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.	Baseline, Week 52
Other	Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score	The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last "week." Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Scores range from 0 to 30 (less to more impairment), and a 4-point change from baseline is considered as the minimal clinically important difference threshold. LS mean was calculated using MMRM model that included treatment group, concomitant csDMARD use at baseline, moderate-to-severe plaque psoriasis involvement, visit as fixed factors, baseline value as covariate and baseline-by-visit and treatment-by-visit interactions terms.	Baseline, Week 52
Other	Percentage of Participants Answering "Mostly Satisfied" to Each Question in Treatment Satisfaction Questionnaire (TSQ)	The TSQ is a clinician-administered questionnaire that provides an assessment of the patient's opinion of the effectiveness, safety, and overall satisfaction of the study medication. Participants were asked to respond to questionnaire items using a 4-point Likert scale (from "mostly satisfied" to "mostly dissatisfied").	Week 52
Other	Number of Participants Who Answered "Yes" to Any 10 Questions in Columbia Suicide Severity Rating Scale (C-SSRS)	The C-SSRS is a scale that captures the occurrence, severity, and frequency of suicide-related ideations and behaviors during the assessment period.; Wish to be dead; Non-specific active suicidal thoughts; Active suicidal ideation with any methods (not plan) without intent to act; Active suicidal ideation with some intent to act, without specific plan; Active suicidal ideation with specific plan and intent; Preparatory acts or behavior; Aborted attempt; Interrupted attempt; Non-fatal suicide attempt; Completed suicide	Week 52
Primary	Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100)	ACR50 response is a =50% improvement from baseline for tender joint count(TJC)& swollen joint count (SJC)& in at least 3 of the following 5 criteria: Participant's(pts) assessment of joint pain Visual Analog Scale (VAS),Pts Global Assessment of Disease Activity (PatGA)VAS, Physician's Global Assessment of Disease Activity (PGA)VAS, Pts assessment of physical function using the Health Assessment Questionnaire-Disability Index(HAQ-DI), or High Sensitivity(assay)C-Reactive Protein (hs-CRP). PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Pts achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Pts with active plaque PsO with a BSA=3% & PASI=0 at baseline were considered PASI100 responders if they had achieved PASI=0 & BSA=0 at week 24.	Week 24
Secondary	Percentage of Participants Achieving ACR50	ACR50 response is defined as a =50% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of joint pain Visual Analog Scale (VAS), Participant's Global Assessment of Disease Activity (PatGA) VAS, Physician's Global Assessment of Disease Activity (PGA) VAS, participant's assessment of physical function using the Health Assessment Questionnaire-Disability Index (HAQ-DI), or High Sensitivity (assay) C-Reactive Protein (hs-CRP).	Week 24
Secondary	Percentage of Participants Achieving PASI100	PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Participants achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Any participants with active plaque psoriasis (PsO) with a BSA =3% and PASI = 0 at baseline were considered PASI100 responders if & only if they had achieved PASI=0 & BSA=0 at week 24.	Week 24

External Links

•   A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis (Spirit-H2H)