Psoriatic Arthritis Response Criteria Response Research Articles

Multi-domain effectiveness of guselkumab evaluated via composite indices through 1 year in patients with PsA and inadequate response to TNFi: post hoc analysis of COSMOS.

Evaluate guselkumab efficacy, an anti-interleukin-23p19-subunit antibody, in patients with active psoriatic arthritis (PsA) and inadequate response to 1-2 tumour necrosis factor inhibitors (TNFi-IR), utilizing composite indices assessing disease activity across disease domains. In the Phase IIIb COSMOS trial, 285 adults with TNFi-IR PsA were randomized (2:1) to receive guselkumab 100 mg or placebo at Week (W)0, W4, then every 8 weeks through W44. Patients receiving placebo crossed over to guselkumab at W24. In this post-hoc analysis, composite indices evaluated included the Disease Activity Index for Psoriatic Arthritis (DAPSA), Disease Activity Score 28 (DAS28), Psoriatic Arthritis Response Criteria (PsARC), Psoriatic Arthritis Disease Activity Score (PASDAS), GRAPPA Composite score (GRACE), modified Composite Psoriatic Disease Activity Index (mCPDAI), minimal disease activity (MDA) and very low disease activity (VLDA). Through W24, treatment failure rules were applied. Through W48, non-responder imputation was used for missing data. Greater proportions of guselkumab- than placebo-randomized patients achieved composite index endpoints relating to low disease activity (LDA; 14.8-52.4% vs 3.1-28.1%) or remission (3.7-5.3% vs 0.0-2.1%) at W24. Among guselkumab-randomized patients, LDA rates increased to W48 (DAPSA, 44.4%; DAS28, 47.8%; PASDAS, 34.4%; GRACE, 33.3%; mCPDAI, 40.2%), and 27.0% and 64.0% achieved MDA and a PsARC response, respectively. In the placebo→guselkumab crossover group, W48 response rates were similar to the guselkumab-randomized group. Guselkumab treatment provided substantial benefits across multiple disease domains, with increasing proportions of patients achieving LDA/remission over 1 year, highlighting the effectiveness of guselkumab despite previous inadequate response to TNFi.

E070 Sustained and consistent efficacy of bimekizumab in patients with active psoriatic arthritis regardless of prior TNF-inhibitor status: results from the phase 3 BE OPTIMAL and BE COMPLETE trials

Abstract Background/Aims Bimekizumab (BKZ), a humanised monoclonal IgG1 antibody that inhibits IL-17A and IL-17F, has demonstrated rapid efficacy in joint and skin outcomes for patients with active psoriatic arthritis (PsA) who are bDMARD-naïve (BE OPTIMAL; NCT03895203) and TNFi-inadequate responders (TNFi-IR) (BE COMPLETE; NCT03896581). Here we report longer-term PsA response criteria (PsARC) response, along with health-related quality of life (HRQoL) outcomes in BE OPTIMAL and BE COMPLETE. Methods BE OPTIMAL and BE COMPLETE were randomised multicentre, double-blind, placebo (PBO)-controlled, parallel-group, phase 3 trials. BE OPTIMAL included a 16-week (Wk) double-blind, PBO-controlled period and a 36-Wk active-treatment period. Patients were randomised (3:2) to receive BKZ 160mg Q4W, or PBO. At Wk16, PBO patients switched to BKZ. In BE COMPLETE, patients with inadequate response or intolerance to TNFis were randomised (2:1) to receive either BKZ 160mg Q4W or PBO for 16Wks after which they were eligible for entry into BE VITAL (NCT04009499; open-label extension). We report PsARC response rates at Wk52 (BE OPTIMAL) and Wk40 (BE COMPLETE). Additionally, the association of PsARC responders with HRQoL-related outcomes (HAQ-DI, FACIT-Fatigue and SF-36) for the randomised set are also reported. Data are reported as non-responder imputation (NRI) and observed cases (OC). Results In BE OPTIMAL, 821/852 (96.4%) patients completed Wk16 and 761 (89.3%) completed Wk52. In BE COMPLETE, 388/400 (97%) patients completed Wk16, 377 (94.3%) entered BE VITAL and 360 (90.0%) completed Wk40. Baseline characteristics were comparable between groups within both trials. In BE OPTIMAL, PsARC response (NRI) was achieved by 80.3% BKZ and 40.2% PBO patients at Wk16 and was sustained or increased at Wk52 to 79.1% BKZ and 79.7% PBO/BKZ patients. In BE COMPLETE, PsARC response (NRI) was achieved by 85.4% BKZ and 30.8% PBO at Wk16 and was sustained or increased at Wk40 to 77.9% BKZ and 75.2% PBO/BKZ patients. Clinically meaningful improvements in HAQ-DI and SF 36-PCS scores, and FACIT-Fatigue were achieved from baseline among PsARC responders compared to non-responders (Table). Conclusion Improvements in PsARC were sustained up to 1 year in BKZ-treated patients and associated with improvement in HRQoL and fatigue, regardless of whether patients were bDMARD-naïve (BE OPTIMAL) or TNFi-IR (BE COMPLETE). Disclosure W.R. Tillett: Other; WRT has received Research funding, consulting and or speaker fees from: Abbvie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma. B. Ink: Shareholder/stock ownership; BI is a shareholder of AbbVie, GlaxoSmithKline and UCB Pharma. R. Bajracharya: Other; RB is an employee and shareholder of UCB Pharma. V. Taieb: Other; VT is an employee of UCB Pharma. P. Sharma: Other; PS has done Advisory Board for UCB Pharma. D. McGonagle: Grants/research support; DM has received research grants/research support from AbbVie, Celgene, Janssen, Merck, and, Pfizer. Other; DM has received honoraria or consultation fees and has been paid as a speaker for AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer, and UCB Pharma. L.C. Coates: Consultancies; LCC has worked as a paid consultant for AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Moonlake, Novartis, Pfizer and UCB Pharma. Grants/research support; LCC has received grants/research support from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma. Other; LCC has been paid as a speaker for AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, Novartis, Pfizer and UCB Pharma. I.B. McInnes: Grants/research support; IM has received grants/research support from Astra Zeneca, Abbvie, BMS, Compugen, Cabaletta, EveloBio, Eli Lilly, GSK, Janssen, Novartis, Moonlake, Novartis, Sanofi, UCB Pharma, XinThera.

P189 Bimekizumab in patients with psoriatic arthritis with prior inadequate response to TNF inhibitors: improvements of PsARC over 16 weeks in the Phase 3 BE COMPLETE trial

Abstract Background/Aims Bimekizumab (BKZ) is a humanised monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A and has demonstrated clinical effectiveness in both joint and skin outcomes in patients with active psoriatic arthritis (PsA). Psoriatic Arthritis Response Criteria (PsARC) is used routinely for drug reimbursement in clinical practice in the UK. We report PsARC response rates along with HRQoL estimates at week (wk) 16 in TNF inadequate responder (TNFi-IR) patients with active PsA from the phase 3, 16-wk BE COMPLETE trial (NCT03896581). Methods BE COMPLETE is a randomised, multicentre, double-blind, placebo (PBO)-controlled, parallel group study. Patients who had an inadequate response or intolerance to treatment with 1 or 2 TNFis were randomised (2:1) to BKZ 160 mg every 4 wks (Q4W) or PBO for 16 wk. We report response rates for PsARC at wk 16, and the association of PsARC responders with HRQoL-related outcomes for the randomised set. Data are reported as non-responder imputation (NRI) and observed cases. Results 400 patients were randomised at baseline (BKZ: 267; PBO: 133). Baseline characteristics were comparable between groups (mean age: 50.5 yrs; BMI: 29.8 kg/m2; disease duration: 9.5 yrs and 47.5% were male). At wk 16, PsARC response (NRI) was achieved by 85.4% with BKZ and 30.8% with PBO (Table). Numerically greater improvements in physical functioning and fatigue measure were achieved from baseline among PsARC responders compared to non-responders (Table). Over 16 wks, safety was in line with previous BKZ studies and no new safety signals were observed. Conclusion In patients with prior TNFi-IR with active PsA, BKZ treatment demonstrated a greater improvement in musculoskeletal symptoms at wk 16 compared to PBO. Patients with PsARC response had numerically greater improvements in HRQoL and improvements in fatigue measures. No new safety signals were observed. Disclosure P. Sharma: Other; PS has received conference sponsorship Amgen 2015 for National Osteoporosis Conference; Janssen Advisory Board board Nov 22. D.R. Jadon: Other; DRJ received research/education grants/honoraria: AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Fresenius Kabi, Gilead, GSK, Healthcare Celltrion, Janssen, Merck, Novartis, Pfizer, Roche, Sandoz and UCB. D. McGonagle: Grants/research support; DM has received research grants/research support from AbbVie, Celgene, Janssen, Merck, and Pfizer. Other; DM has recevied honoraria or consultation fees and has been paid as a speaker for AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer, and UCB Pharma. B. Ink: Shareholder/stock ownership; BI is a shareholder of AbbVie, GlaxoSmithKline and UCB Pharma. D. Assudani: Shareholder/stock ownership; Employee and shareholder of UCB Pharma. V. Taieb: Other; VT is employee of UCB Pharma. L.C. Coates: Consultancies; LCC has worked as a paid consultant for AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Moonlake, Novartis, Pfizer and UCB Pharma. Member of speakers’ bureau; LCC has been paid as a speaker for AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, Novartis, Pfizer and UCB Pharma. Grants/research support; LCC has received grants/research support from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma.

OA36 Bimekizumab in patients with psoriatic arthritis: achievement and maintenance of Psoriatic Arthritis Response Criteria responses through 3 years in a phase 2b open-label extension study

Abstract Background/Aims Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL17A, has demonstrated an acceptable safety profile with improvements in joint and skin outcomes to 3 years in patients with active psoriatic arthritis (PsA). Psoriatic Arthritis Response Criteria (PsARC) response data can help relate clinical trial data to UK clinical practice. We report PsARC response rates to 3 years in patients with active PsA from the phase 2b 48-week (wk) dose-ranging study BE ACTIVE (NCT02969525) and its open-label extension (OLE)(NCT03347110). Methods In BE ACTIVE, patients were randomised (1:1:1:1:1) to placebo, BKZ 16mg, BKZ 160mg (with or without 320mg loading dose), or BKZ 320mg, every 4 wks (Q4W). At Wk12, patients assigned to placebo or BKZ 16mg were reassigned (1:1) to dose-blind BKZ 160mg or 320mg Q4W; other patients remained on their original dose. From Wk48 all patients received open-label BKZ 160mg Q4W. We report PsARC to Wk152 and maintenance of response among patients with PsARC response at Wk12, for the full analysis set (FAS). Data are reported as observed and with NRI. Results 206 patients were randomised at baseline in BE ACTIVE and included in the FAS. 181 patients entered the OLE and 161 completed the OLE. 157 patients had calculable PsARC response at Wk152. At Wk12, PsARC response (NRI) was achieved by 125/206, including placebo: 33.3% (14/42), BKZ 16mg: 56.1% (23/41), 160mg: 73.2% (60/82), 320mg: 68.3% (28/41) (Table). At Wk48 and Wk152, 78.2% (161/206) and 68.0% (140/206) patients were PsARC responders, respectively. Of the 125 PsARC responders at Wk12, 88.8% (111/125) also met PsARC at Wk48 and 74.4% (93/125) were PsARC responders at Wk152 (NRI). Over 152 wks, the exposure-adjusted incidence rate per 100 patient-years was 126.4 for all treatment-emergent adverse events (TEAEs), 4.1 for serious TEAEs, 0.7 for serious infections and 4.6 for Candida infections. Conclusion A numerically higher proportion of patients achieved PsARC response in all BKZ-treated groups at Wk12, compared with placebo. The PsARC response rate was sustained through 3 years. Nearly three-quarters of patients who achieved PsARC at Wk12 were also PsARC responders at Wk152. No new safety signals were observed. Disclosure W. Tillett: Consultancies; WT has received consulting fees from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer and UCB Pharma. Honoraria; WT has received honoraria from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer and UCB Pharma. Grants/research support; WT has received research grants from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer and UCB Pharma. I.B. McInnes: Consultancies; IBM has received consulting fees from AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, UCB Pharma. Honoraria; IBM has received honoraria from AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Novartis, UCB Pharma. Grants/research support; IBM has received research support from Boehringer Ingelheim, BMS, Celgene, Janssen and UCB Pharma. D. McGonagle: Consultancies; DM has received consulting fees from AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer and UCB Pharma. Honoraria; DM has received honoraria from AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer and UCB Pharma. Member of speakers’ bureau; DM has been on speaker’s bureau for AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer and UCB Pharma. Grants/research support; DM has received grants/research support from AbbVie, Celgene, Janssen, Merck, Pfizer and Novartis. D.R. Jadon: Consultancies; DRJ has received consultancy fees from AbbVie, Amgen, Biogen, BMS, Celgene, Celltrion, Eli Lilly, Fresenius Kabi, Galapagos, GSK, Janssen, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi and UCB Pharma. Grants/research support; DRJ has received research grants from AbbVie, Amgen, Biogen, BMS, Celgene, Celltrion, Eli Lilly, Fresenius Kabi, Galapagos, GSK, Janssen, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi, UCB Pharma. B. Ink: Corporate appointments; BI is an employee of UCB Pharma. Shareholder/stock ownership; BI is a shareholder of GSK and UCB Pharma. D. Assudani: Corporate appointments; DA is an employee of UCB Pharma. Shareholder/stock ownership; DA is a shareholder of UCB Pharma. J. Coarse: Corporate appointments; JC is an employee of UCB Pharma. Shareholder/stock ownership; JC is a shareholder of UCB Pharma. J. Eells: Corporate appointments; JE is an employee of UCB Pharma. Shareholder/stock ownership; JE is a shareholder of UCB Pharma. L.C. Coates: Consultancies; LCC has received consulting fees from AbbVie, Amgen, Biogen, Boehringer Ingelheim, Celgene, Domain, Eli Lilly, Gilead and Janssen. Member of speakers’ bureau; LCC has been on speaker’s bureau for AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Gilead, GSK, Janssen, Medac, Novartis, Pfizer and UCB Pharma. Grants/research support; LCC has received grants/research support from AbbVie, Amgen, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer and UCB Pharma.

Real-World Efficacy and Safety of Apremilast in Belgian Patients with Psoriatic Arthritis: Results from the Prospective Observational APOLO Study.

IntroductionApremilast is approved for the treatment of psoriasis and psoriatic arthritis (PsA). Real-world evidence on the efficacy and safety of apremilast in clinical practice is limited. We assessed the use of apremilast in patients with PsA in Belgium clinical practice.MethodsThe multicentre, observational, prospective APOLO study enrolled patients with active PsA initiating apremilast in Belgium between April 2017 and December 2018. Primary outcome was PsA Response Criteria (PsARC) after 6 months of apremilast treatment. Secondary outcomes included PsA Impact of Disease 12 (PsAID12) and Health Assessment Questionnaire Disability Index (HAQ-DI). Disease-specific outcomes and patient-reported outcomes (PROs) were analysed for patients who received apremilast within 30 days prior to their study inclusion and completed at least 150 days of treatment (reference set [REF]).ResultsOf 107 patients enrolled in the study, 106 received at least one dose of apremilast and 69 were included in the REF. PsARC response was achieved by 43.5% of patients (30/69) in the REF at month 6; mean global and composite scores including 68-joint count for pain/tenderness (68-TJC) and 66-joint count for swelling (66-SJC) improved, and 27% and 42% of patients with 68-TJC and 66-SJC > 0 at baseline had complete joint count resolution, respectively. Mean global and composite PsAID12 and HAQ-DI scores decreased at 6 months, indicating improved quality of life. Apremilast was well tolerated and the reported adverse events were in line with the known safety profile.ConclusionResults from the APOLO study indicate that treatment with apremilast in Belgian clinical practice improves the signs and symptoms of PsA as well as patient quality of life.Clinicaltrials.gov IdentifierNCT03096990.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-021-02016-x.

P174 Upadacitinib response rates in patients with psoriatic arthritis enrolled in the SELECT-PsA-1 and SELECT-PsA-2 trials assessed according to modified PsARC

P174 Upadacitinib response rates in patients with psoriatic arthritis enrolled in the SELECT-PsA-1 and SELECT-PsA-2 trials assessed according to modified PsARC

Cost-effectiveness analysis of ixekizumab versus secukinumab in patients with psoriatic arthritis and concomitant moderate-to-severe psoriasis in Spain

ObjectiveTo conduct a cost-effectiveness analysis from the perspective of the Spanish National Health System (NHS) comparing ixekizumab versus secukinumab.DesignA Markov model with a lifetime horizon and monthly cycles was developed...

OP0226 NETAKIMAB DECREASES DISEASE ACTIVITY IN PATIENTS WITH PSORIATIC ARTHRITIS: RESULTS FROM A RANDOMIZED DOUBLE-BLIND PHASE 3 CLINICAL TRIAL (PATERA)

Background:Netakimab (NTK) is a humanized anti-interleukin 17A antibody approved for the treatment of moderate-to-severe plaque psoriasis.Objectives:To determine the efficacy and safety of NTK in patients (pts) with active psoriatic arthritis (PsA), based on 24-week (Wk) data from an ongoing phase 3 study (NCT03598751, PATERA).Methods:194 eligible adult pts with PsA (CASPAR, 2006) with inadequate response to csDMARD or one TNFi, were randomized (1:1) to receive NTK 120 mg or placebo (PBO) subcutaneously at Wk 0, 1, 2, 4, 6, 8, 10, 14, 18, 22. 84 pts from PBO arm who did not meet ACR20 (20% improvement of the American College of Rheumatology criteria) by Wk 16 were switched to NTK 120 mg. The primary endpoint was AСR20 at Wk 24. DAPSA (Disease Activity Index for Psoriatic Arthritis), the proportion of pts achieved ACR50/70, minimal disease activity (MDA) (≥5/7 MDA criteria) and Psoriatic arthritis response criteria (PsARC) were also analyzed.Results:Baseline demographics and disease characteristics were similar across treatment arms (Table 1). 80 (82.47%) pts in NTK arm and 9 (9.28%) in the PBO arm achieved ACR20 at Wk 24 (р<0.0001). A significantly greater percentage of NTK-treated pts had ACR50/70, PsARC response, MDA at Wk 24 (Figure 1). By Wk 24 DAPSA significantly improved for NTK vs PBO. DAPSA remission was achieved by 36.08% and 13.40% in NTK and PBO arms, respectively (p=0.003). NTK was well tolerated. The most frequent AEs (≥3%) were lymphopenia, neutropenia, hypercholesterolemia, ALT increased, upper respiratory tract infection, systolic blood pressure increased, hyperglycemia, hyperbilirubinemia. Most AEs were mild to moderate. Severe treatment-related AEs were observed in 1.03% vs 2.06% for NTK and PBO, respectively. No treatment-related SAEs were reported. No anti-drug antibodies were detected.Table 1.Baseline demographics and disease severity characteristicsArmNTK (N=97)PBO (N=97)Age (years) *44.0 (11.66)43.1 (11.88)Male, n (%)52 (53.61)50 (51.55)PsA duration, mo*63.1 (73.12)68.2 (77.49)DAS28-CRP*4.62 (0.97)4.41 (1.11)DAPSA*32.19 (12.23)33.54 (15.98)TJC (66/68) *12.9 (9.97)12.0 (9.88)SJC (66/68) *7.0 (4.93)7.2 (7.18)MTX at baseline83 (85.6)83 (85.6)Previous PsA therapySulfasalazine, n (%)9 (9.28)11 (11.34)Leflunomide, n (%)4 (4.12)8 (8.25)Anti-TNFα, n (%)22 (22.68)17 (17.53)* mean (standard deviation); Mo=months, PsA=psoriatic arthritis, SJC=swollen joint count, TJC=tender joint count, DAS28=Disease Activity Score, MTX=methotrexate, CRP=C-reactive protein, DAPSA=Disease activity index for psoriatic arthritis, TNF=tumor necrosis factorFigure 1.Treatment response at Wk 24Conclusion:NTK is a well-tolerated monoclonal antibody, that provided sustained improvements in signs and symptoms of active PsA through 24 Wks of therapy.Table 2.Safety dataArmNTK (N=97)PBO (N=97)p-valueTreatment-related AEs12 (12.37)7 (7.22)0.2271Treatment-related SAEs0 (0)0 (0)1.002Treatment-related AEs (grade 3-4)1 (1.03)2 (2.06)1.002Local reactions0 (0)0 (0)-Grade 3-4 treatment-related AEsblood pressure increased1 (1.03)0(0)1.002lymphopenia0 (0)2 (2.06)0.4972n (%) are presented,1Pearson’s χ2test,2Fisher’s exact test; N=number of patients, AE=adverse event, SAE=serious adverse event, ALT=Alanine transaminaseAcknowledgments:This study was sponsored by JSC BIOCAD.Disclosure of Interests:Tatiana Korotaeva Consultant of: Pfizer, MSD, Novartis, AbbVie, Celgene, JSC BIOCAD, Janssen, UCB, Lilly and Novartis-Sandoz, Speakers bureau: Pfizer, MSD, Novartis, AbbVie, Celgene, JSC BIOCAD, Janssen, UCB, Lilly and Novartis-Sandoz, Inna Gaydukova Grant/research support from: JSC BIOCAD, Speakers bureau: Pfizer, Novartis, AbbVie, JSC BIOCAD, Сelgene, MSD, Sanofi, V Mazurov: None declared, Aleksey Samtsov Grant/research support from: JSC BIOCAD, Novartis, Eli Lilly, Johnson&Johnson, Celgene, Glenmark, Galderma, Sanofi, Vladislav Khayrutdinov Grant/research support from: Akrikhin, Alkoy, Belupo, JSC BIOCAD, Bosnaliejk, Verteks, Glenmark, Elfa, Leo Pharma, MSD, Novartis, Pfizer, Sun Pharma, Sanofi, Celgene, Pharmtec, AbbVie, Eli Lilly, Jadran, Janssen, Andrey Bakulev Grant/research support from: AbbVie, Eli Lilly, Pfizer, UCB, MSD, Novartis, Galderma, Celgene, Leo Pharma and Johnson&Johnson, JSC BIOCAD, Consultant of: Novartis, Celgene and Johnson&Johnson, Speakers bureau: AbbVie, Eli Lilly, Galderma, UCB, Novartis, Celgene and Johnson&Johnson, Muza Kokhan Grant/research support from: AbbVie, Eli Lilly, Pfizer, UCB, MSD, Novartis, Galderma, Celgene, Leo Pharma and Johnson&Johnson, JSC BIOCAD, Consultant of: Novartis, Celgene and Johnson&Johnson, Speakers bureau: AbbVie, Eli Lilly, Galderma, UCB, Novartis, Celgene and Johnson&Johnson, Alena Kundzer: None declared, Nikolaj Soroka Grant/research support from: JSC BIOCAD, Ekaterina Dokukina Employee of: JSC BIOCAD, Anna Eremeeva Employee of: JSC BIOCAD

Efficacy and safety of biologics in psoriatic arthritis: a systematic literature review and network meta-analysis

BackgroundBiologic disease-modifying antirheumatic drugs (bDMARDs) and targeted synthetic DMARDs are used in patients with psoriatic arthritis (PsA), but few studies directly compare their clinical efficacy. In such situations, network meta-analysis...

PBI14 COST-EFFECTIVENESS OF SECUKINUMAB VERSUS OTHER BIOLOGICS AND APREMILAST IN THE TREATMENT OF ACTIVE PSORIATIC ARTHRITIS: A SPANISH PERSPECTIVE

To assess the cost-effectiveness of secukinumab, an interleukin-17A inhibitor, with other biologics and apremilast in psoriatic arthritis (PsA) patients from a Spanish payers’ perspective. Secukinumab 150 mg and 300 mg were evaluated against etanercept, certolizumab pegol, adalimumab, golimumab, ustekinumab, infliximab, and apremilast over a lifetime horizon in a semi-Markov model. Both biologic-naïve (with or without moderate to severe psoriasis) and biologic-experienced PsA patients were considered. To assess treatment response, the 12-week PsA Response Criteria (PsARC) was used as a primary criterion. Model inputs were derived from PsA clinical trials, published literature, and other Spanish sources. Quality-adjusted life years (QALYs) gained and incremental cost-effectiveness ratio were key model outcomes. Impact of input variations were evaluated through sensitivity analyses and alternative scenario analyses. Secukinumab 150 mg dominated all subcutaneous (S.C.) biologics and apremilast with highest QALYs of 9.22 and lowest lifetime cost of €192,445, while it was cost-effective against the intravenous (I.V.) infliximab in biologic-naïve patients without psoriasis. Among biologic-naïve patients with psoriasis and biologic-experienced patients, secukinumab 300 mg was cost-effective against all S.C. branded biologics and apremilast, while it dominated I.V. infliximab. PsARC response at 3-months, drug acquisition costs, and Health Assessment Questionnaire score change were identified as the most important parameters affecting model results as per one-way sensitivity analysis. Probabilistic sensitivity analysis showed maximum net monetary benefits with both secukinumab doses. Results from scenario analyses confirmed these results. Secukinumab is a cost-effective biologic treatment for PsA patients from a Spanish payer’s perspective.

Efficacy and safety of leflunomide in psoriatic arthritis treatment: A single-arm meta-analysis.

To systematically assess the clinical efficacy and safety of leflunomide for treating psoriatic arthritis (PsA). PubMed, Embase, and Cochrane Library databases were searched until 1 January, 2018, to include relevant studies in this single-arm meta-analysis. Psoriasis improvement was evaluated using Psoriasis Area and Severity Index (PASI) scores. The primary outcome in patients was assessed using the Psoriatic Arthritis Response Criteria (PsARC). Other effectiveness evaluations included those of adverse events, quality of life including functional status (Health Assessment Questionnaire [HAQ] total score), and a quality-of-life instrument for dermatologic diseases (Dermatology Life Quality Index [DLQI] total score). A total of 6 studies were included. After leflunomide treatment, 48% of the patients experienced a reduction of ≥50% based on PASI scores (95% confidence interval [CI]: 0.22-0.73). PASI 75 improvement was observed among 25% of the patients (95% CI: 0.11-0.38). The primary effectiveness analysis revealed that 15% of the patients (95% CI: 0.07-0.26) discontinued leflunomide treatment. Further, 77% of the patients (95% CI: 0.59-0.92) achieved a PsARC response. Adverse events occurred in 38% of the patients (95% CI: 0.04-0.71). The mean±SD percentage PASI improvement was -4.88 (95% CI: -8.92, -0.85). Moreover, DLQI and HAQ were -2.02 (95% CI: -3.01, -1.03) and -0.19 (95% CI: -0.29, -0.09), respectively. Leflunomide is an effective and well-tolerated treatment for PsA, and would be a safe and convenient option.

Methotrexate for psoriatic arthritis.

Methotrexate for psoriatic arthritis.

Cost-effectiveness analysis of secukinumab versus other biologics and apremilast in the treatment of active Psoriatic arthritis: a Finnish perspective

ObjectiveTo study cost-effectiveness of an interleukin (IL)-17A inhibitor secukinumab, with other biologics and apremilast in patients with Psoriatic arthritis (PsA) from payer perspective in Finland.MethodsIn this semi-Markov model, subcutaneous (SC) secukinumab was compared with SC treatments etanercept and its biosimilar, certolizumab pegol, adalimumab and its biosimilar, golimumab, ustekinumab, intravenous (IV) treatment infliximab, as well as oral non-biologic apremilast. Patients without prior exposure (naïve) to biologics and without moderate to severe psoriasis were considered for secukinumab 150 mg group. Secukinumab 300 mg group included naïve patients with moderate to severe psoriasis and all patients with prior biologic exposure. The PsA Response Criteria (PsARC) at 12-week was primary criteria for treatment response. Other clinical as well as cost related model inputs were derived from relevant clinical trials as well as Finnish publications. The key model outcomes were quality-adjusted life years and incremental cost-effectiveness ratio. An annual 3% discount rate was applied to all future costs and benefits. Model input variations were assessed through sensitivity analyses and alternative scenario analyses.ResultsFor a lifetime horizon (60 years), secukinumab 150 mg dominated all branded SC biologics and apremilast with highest QALY of 8.01 and lowest lifetime cost of €187,776, while it was cost-effective against IV infliximab among biologic-naïve patients without moderate to severe psoriasis. Secukinumab 300 mg was cost-effective against all branded SC biologics and apremilast and dominated IV infliximab among biologic-naïve patients with moderate to severe psoriasis, while it was cost-effective in biologic experienced patients. With the one-way sensitivity analysis, PsARC response, drug acquisition cost, and health assessment questionnaire score were the most important parameters affecting the outcomes. Across all treatment groups, patients on secukinumab were most likely to achieve highest net monetary benefit than other competitors in probabilistic sensitivity analysis. With alternative scenario analysis, results largely remained unchanged.ConclusionsSecukinumab is a cost-effective treatment for PsA patients from a Finnish payer’s perspective.

PMU67 - COST-EFFECTIVENESS ANALYSIS OF IXEKIZUMAB VERSUS SECUKINUMAB IN PATIENTS WITH PSORIATIC ARTHRITIS AND CONCOMITANT MODERATE-TO-SEVERE PSORIASIS IN THE UNITED KINGDOM

Biologic disease-modifying antirheumatic drugs (bDMARDs) are a major driver of total costs in psoriatic arthritis (PsA), a chronic inflammatory rheumatic condition associated with psoriasis. To date, there are no cost-effectiveness analyses (CEAs) comparing the interleukin-17A antagonists ixekizumab and secukinumab in PsA in the UK. We conducted a CEA from the UK National Health Service perspective to compare the cost-effectiveness of ixekizumab versus secukinumab in bDMARD-naïve patients with PsA and concomitant moderate-to-severe psoriasis. A Markov model derived from the widely accepted York model was developed. The model used a lifetime horizon with monthly cycles. Treatment sequences evaluated were ixekizumab→ustekinumab→best supportive care (BSC) versus secukinumab→ustekinumab→BSC. The model included the health states trial bDMARD period, continuous bDMARD treatment, BSC and death. At the end of the bDMARD trial period, Psoriatic Arthritis Response Criteria (PsARC) responders transitioned to continuous treatment with trial bDMARD. PsARC non-responders and patients who discontinued continuous treatment transitioned to trial period of next bDMARD or BSC, as appropriate. Clinical efficacy was measured in terms of proportion of patients achieving a PsARC response and change from baseline Health Assessment Questionnaire – Disability Index (HAQ-DI) and Psoriasis Area Severity Index (PASI) scores, which were derived from network meta-analyses. Health utilities were estimated by applying regression analysis to HAQ-DI and PASI scores collected in the SPIRIT trials with ixekizumab in PsA. Only direct medical costs were included. Ixekizumab was associated with lower total costs (£155,455 vs £155,530 [year of costing 2017]) and higher total QALYs (8.127 vs 7.989) than secukinumab, although differences were modest. Robustness of results was assessed through deterministic and probabilistic sensitivity analyses. In bDMARD-naïve patients with PsA and concomitant moderate-to-severe psoriasis in the UK, first-line ixekizumab in this biologic treatment sequence provided slight advantages in cost savings and QALYs gained over first-line secukinumab in a similar sequence.

Cost-effectiveness analysis of secukinumab for the treatment of active psoriatic arthritis: a Canadian perspective

Objective: The study evaluates the cost-effectiveness of secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin (IL)-17A, vs currently licensed biologic treatments in patients with active psoriatic arthritis (PsA) from a Canadian healthcare system perspective.Methods: A decision analytic semi-Markov model evaluated the cost-effectiveness of secukinumab 150 mg and 300 mg compared to subcutaneous biologics adalimumab, certolizumab pegol, etanercept, golimumab, and ustekinumab, and intravenous biologics infliximab and infliximab biosimilar in biologic-naive and biologic-experienced patients over a lifetime horizon. The response to treatments was evaluated after 12 weeks by PsA Response Criteria (PsARC) response rates. Non-responders or patients discontinuing initial-line of biologic treatment were allowed to switch to subsequent-line biologics. Model input parameters (Psoriasis Area Severity Index [PASI], Health Assessment Questionnaire [HAQ], withdrawal rates, costs, and resource use) were collected from clinical trials, published literature, and other Canadian sources. Benefits were expressed as quality-adjusted life years (QALYs). An annual discount rate of 5% was applied to costs and benefits. The robustness of the study findings were evaluated via sensitivity analyses.Results: Biologic-naive patients treated with secukinumab achieved the highest number of QALYs (8.54) at the lowest cost (CAD 925,387) over a lifetime horizon vs all comparators. Secukinumab dominated all treatments, except for infliximab and its biosimilar, which achieved minimally more QALYs (8.58). However, infliximab and its biosimilar incurred more costs than secukinumab (infliximab: CAD 1,015,437; infliximab biosimilar: CAD 941,004), resulting in higher cost-effectiveness estimates relative to secukinumab. In the biologic-experienced population, secukinumab dominated all treatments as it generated more QALYs (8.89) at lower costs (CAD 954,692). Deterministic sensitivity analyses indicated the results were most sensitive to variation in PsARC response rates, change in HAQ, and utility values in both populations.Conclusions: Secukinumab is either dominant or cost-effective vs all licensed biologics for the treatment of active PsA in biologic-naive and biologic-experienced populations in Canada.

Methotrexate for psoriatic arthritis

Methotrexate for psoriatic arthritis

Systematic review, network meta-analysis and economic evaluation of biological therapy for the management of active psoriatic arthritis.

BackgroundAn updated economic evaluation was conducted to compare the cost-effectiveness of the four tumour necrosis factor (TNF)-α inhibitors adalimumab, etanercept, golimumab and infliximab in active, progressive psoriatic arthritis (PsA) where response to standard treatment has been inadequate.MethodsA systematic review was conducted to identify relevant, recently published studies and the new trial data were synthesised, via a Bayesian network meta-analysis (NMA), to estimate the relative efficacy of the TNF-α inhibitors in terms of Psoriatic Arthritis Response Criteria (PsARC) response, Health Assessment Questionnaire (HAQ) scores and Psoriasis Area and Severity Index (PASI). A previously developed economic model was updated with the new meta-analysis results and current cost data. The model was adapted to delineate patients by PASI 50%, 75% and 90% response rates to differentiate between psoriasis outcomes.ResultsAll four licensed TNF-α inhibitors were significantly more effective than placebo in achieving PsARC response in patients with active PsA. Adalimumab, etanercept and infliximab were significantly more effective than placebo in improving HAQ scores in patients who had achieved a PsARC response and in improving HAQ scores in PsARC non-responders. In an analysis using 1,000 model simulations, on average etanercept was the most cost-effective treatment and, at the National Institute for Health and Care Excellence willingness-to-pay threshold of between £20,000 to £30,000, etanercept is the preferred option.ConclusionsThe economic analysis agrees with the conclusions from the previous models, in that biologics are shown to be cost-effective for treating patients with active PsA compared with the conventional management strategy. In particular, etanercept is cost-effective compared with the other biologic treatments.

SAT0298 Systematic review and network meta-analysis of biological therapy for the management of active psoriatic arthritis

BackgroundPsoriatic arthritis (PsA) is a chronic systemic inflammatory disease with articular and dermatological manifestations. PsA varies in severity and type of tissue involvement and may significantly impact patients’ function and...

AB0946 Anti-TNF treated psoriatic arthritis: Course of composite disease activity measures and clinical core domains

BackgroundPsoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis, and The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) has defined clinical core domains for assessment...

Leflunomide in psoriatic arthritis: Results from a large European prospective observational study

To determine the "real-world" clinical effectiveness and safety of leflunomide in patients with psoriatic arthritis (PsA). This prospective, multinational 24-week observational study involved adult patients with active PsA who initiated treatment with leflunomide. Patients were evaluated at baseline, 12 weeks, and 24 weeks. The primary outcome was response as assessed by the Psoriatic Arthritis Response Criteria (PsARC) in patients with pre- and posttreatment data. A modified PsARC response analysis included patients with joint counts, but no severity scores. Other effectiveness evaluations included global assessments, fatigue, pain, skin disease, dactylitis, and nail lesions. All patients were evaluated for safety. A total of 514 patients were enrolled in this study (mean age 50.7 years, mean disease duration 6.1 years). In the primary effectiveness analysis, 380 (86.4%) of 440 patients (95% confidence interval 82.8%-89.4%) achieved a PsARC response at 24 weeks. Significant improvements were observed in tender and swollen joint scores and counts, patient and physician global assessments, fatigue, pain, skin disease, dactylitis, and nail lesions. The discontinuation rate was 12.3%. Ninety-eight adverse drug reactions occurred in 62 (12.1%) patients; 3 drug reactions were serious (2 increased liver enzymes, 1 hypertensive crisis). Leflunomide is an effective and well-tolerated option for PsA in daily clinical practice, with beneficial effects on peripheral arthritis and on other PsA manifestations, including pain, fatigue, dactylitis, and skin disease.