The aim of the present investigation was to assess and compare health status instruments in SLE. One hundred and twenty-five patients completed five health status instruments: the Health Assessment Questionnaire (HAQ), Functional Ability Index, the Fatigue Severity Scale (FSS), the Disability Days Measure (DDM), the Centre for Epidemiological Studies-Depression Scale (CES-D), and the Medical Outcomes Study (MOS) Short Form Health Survey during their Clinic visit. Disease activity was measured using the SLE Disease Activity Index (SLEDAI). All instruments described a spectrum of quality of life outcomes in these patients. An inter-instrument correlation analysis revealed that components of the MOS correlated significantly with each of the other instruments used. There was no correlation between any of the instruments used and the SLEDAI. We conclude that health status assessment as measured by the MOS short form is a valid independent outcome measure in patients with SLE.

Background:Since the 2015 GRAPPA treatment recommendations were published, therapeutic options and management strategies for psoriatic arthritis (PsA) have advanced considerably.Objectives:The goal of the GRAPPA recommendations update is to develop high quality, evidence-based recommendations for the treatment of PsA, including related conditions and comorbidities.Methods:GRAPPA rheumatologists, dermatologists and patient research partners (PRPs) updated overarching principles for the management of adults with PsA by consensus. Principles considering use of biosimilars and tapering/discontinuing of therapy were added to this update. Systematic literature searches based on data publicly available from three databases (MEDLINE, EMBASE, and Cochrane CENTRAL) were conducted from the end of the previous recommendations’ searches through August 2020. Additional abstract searches were performed for conference presentations in 2017-2020. Searches covered PsA treatments (peripheral arthritis, axial arthritis, enthesitis, dactylitis, skin, and nail disease). Additional searches were performed for related conditions (uveitis and IBD) and comorbidities evaluating their impact on safety and treatment outcomes. Individual groups assessed the risk of bias and applied the GRADE system to generate strong or conditional recommendations for therapies within the domain groups and for the management of comorbidities and related conditions. These recommendations were then incorporated into an overall treatment schema.Results:Updated, evidence-based treatment recommendations are shown (Table 1). Since 2015, many new medications have been incorporated. Additional results for older medications, such as methotrexate, have been published across PsA domains. Based on the evidence, the treatment recommendations developed by individual groups were incorporated into the overall schema including principles for management of arthritis, spondylitis, enthesitis, dactylitis, skin, and nail disease in PsA, and associated conditions (Figure 1). Choice of therapy for an individual should ideally address all of the domains that impact on that patient, supporting shared decision making with the patient involved. Additional consideration in the recommendations was given to key associated conditions and comorbidities as these often impact on therapy choice.Conclusion:These GRAPPA treatment recommendations provide up to date, evidence-based guidance to providers who manage and treat adult patients with PsA. These recommendations are based on domain-based strategy for PsA and supplemented by overarching principles developed by consensus of GRAPPA members.IndicationStrongForConditional ForConditionalAgainstStrongAgainstInsufficient evidencePeripheral Arthritis DMARD NaïvecsDMARDs, TNFi, PDE4i, IL-12/23i, IL-17i, IL-23i, JAKiNSAIDs, oral CS, IA CS,IL-6i,Peripheral Arthritis DMARD IRTNFi, IL-12/23i, IL-17i, IL-23i, JAKiPDE4i, other csDMARD, NSAIDs, oral CS, IA CS,IL-6i,Peripheral ArthritisbDMARD IRTNFi, IL-17i, IL-23i, JAKi,NSAIDs, oral CS, IA CS, IL-12/23i, PDE4i, CTLA-4-IgIL-6i,Axial arthritis, Biologic NaïveNSAIDs, Physiotherapy, simple analgesia, TNFi, IL-17i, JAKiCS SIJ injections, bisphosphonatescsDMARDs, IL-6i,IL-12/23i, IL-23iAxial PsA, Biologic IRNSAIDs, Physiotherapy, simple analgesia, TNFi, IL-17i, JAKi csDMARDs, IL-6i,IL-12/23i, IL-23iEnthesitisTNFi, IL-12/23i, IL-17i, PDE4i, IL-23i, JAKiNSAIDs, physiotherapy, CS injections, MTXIL-6i,Other csDMARDsDactylitisTNFi IL-12/23i, IL-17i, IL-23i, JAKi, PDE4iNSAIDs, CS injections, MTXOther csDMARDsPsoriasisTopicals, phototherapy, csDMARDs, TNFi, IL-12/23i, IL-17i, IL-23i, PDE4i, JAKi AcitretinNail psoriasisTNFi, IL12/23i, IL17i, IL23i, PDE4iTopical CS, tacrolimus and calcipotriol combination or individual therapies, Pulsed dye laser, csDMARDs, acitretin, JAKiTopical Cyclosporine / Tazarotene, Fumarate, Fumaric Acid Esters, UVA and UVB Phototherapy, AlitretinoinIBDTNFi (not ETN), IL-12/23i, JAKiIL-17iUveitisTNFi (not ETN)Disclosure of Interests:Laura C Coates Speakers bureau: AbbVie, Amgen, Biogen, Celgene, Gilead, Eli Lilly, Janssen, Medac, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Amgen, Celgene, Eli Lilly, Pfizer, and Novartis, Enrique Soriano Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb,GSK, Genzyme, Janssen, Lilly, Novartis, Pfizer, Roche, Sandoz, Sanofi, UCB, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb,GSK, Genzyme, Janssen, Lilly, Novartis, Pfizer, Roche, Sandoz, Sanofi, UCB, Grant/research support from: AbbVie, Janssen, Novartis Pharma, Pfizer, Roche, and UCB, Nadia Corp: None declared, Heidi Bertheussen Consultant of: Pfizer, Kristina Callis-Duffin Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Lilly, Janssen, Novartis, Pfizer, Sienna Biopharmaceuticals, Stiefel Laboratories, UCB, Ortho Dermatologics, Inc, Regeneron Pharmaceuticals, Inc., Anaptys Bio, Boehringer Ingelheim., Cristiano Barbosa Campanholo Speakers bureau: AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Jeffrey Chau: None declared, Lihi Eder Consultant of: Abbvie, UCB, Janssen, Eli Lily, Pfizer, Novartis, Grant/research support from: Abbvie, UCB, Janssen, Eli Lily, Pfizer, Novartis, Daniel Fernandez Consultant of: Abbvie, UCB, Roche, Janssen, Pfizer, Amgen and Brystol, Grant/research support from: Abbvie, UCB, Roche, Janssen, Pfizer, Amgen and Brystol, Oliver FitzGerald Speakers bureau: AbbVie, Janssen and Pfizer Inc, Consultant of: BMS, Celgene, Eli Lilly, Janssen and Pfizer Inc, Grant/research support from: AbbVie, BMS, Eli Lilly, Novartis and Pfizer Inc, Amit Garg Consultant of: Abbvie, Amgen, Asana Biosciences, Bristol Myers Squibb, Boehringer Ingelheim, Incyte, InflaRx, Janssen, Pfizer, UCB, Viela Biosciences, Grant/research support from: Abbvie, Dafna D Gladman Consultant of: Abbvie, Amgen, BMS, Eli Lilly, Galapagos, Gilead, Jansen, Novartis, Pfizer and UCB, Grant/research support from: Abbvie, Amgen, Eli Lilly, Jansen, Novartis, Pfizer and UCB, Niti Goel: None declared, Suzanne Grieb: None declared, Philip Helliwell Speakers bureau: Janssen, Novartis, Pfizer, Consultant of: Eli Lilly, M Elaine Husni Consultant of: Abbvie, Amgen, Janssen, Novartis, Lilly, UCB, Regeneron, and Pfizer, Deepak Jadon Speakers bureau: AbbVie, Amgen, Celgene, Eli Lilly, Gilead, Healthcare Celltrion, Janssen, MSD, Novartis, Pfizer, Roche, Sandoz, UCB, Consultant of: AbbVie, Amgen, Celgene, Eli Lilly, Gilead, Healthcare Celltrion, Janssen, MSD, Novartis, Pfizer, Roche, Sandoz, UCB, Grant/research support from: AbbVie, Amgen, Celgene, Eli Lilly, Gilead, Healthcare Celltrion, Janssen, MSD, Novartis, Pfizer, Roche, Sandoz, UCB, Arnon Katz: None declared, Dhruvkumar Laheru: None declared, John Latella: None declared, Ying Ying Leung Speakers bureau: Novartis, AbbVie, Eli Lilly, Janssen, Consultant of: Pfizer and Boehringer Ingelheim, Grant/research support from: Pfizer and conference support from AbbVie, Christine Lindsay Shareholder of: Amgen, Employee of: Aurinia pharmaceuticals, Ennio Lubrano Speakers bureau: Alfa-Sigma, Abbvie, Galapagos, Janssen Cilag, Lilly., Consultant of: Alfa-Sigma, Abbvie, Galapagos, Janssen Cilag, Lilly., Luis Mazzuoccolo Speakers bureau: Abbvie, Amgen, Novartis, Elli Lilly, Jansen, Consultant of: Abbvie, Amgen, Novartis, Elli Lilly, Jansen, Roland McDonald: None declared, Philip J Mease Speakers bureau: AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Galapagos, Gilead Sciences, GlaxoSmithKline, Janssen, Novartis, Pfizer, SUN and UCB, Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead Sciences, Janssen, Novartis, Pfizer, SUN and UCB, Denis O’Sullivan: None declared, Alexis Ogdie Consultant of: AbbVie, Amgen, BMS, Celgene, Corrona, Gilead, Janssen, Lilly, Novartis, and Pfizer, Grant/research support from: Novartis and Pfizer and Amgen, Wendy Olsder: None declared, Lori Schick: None declared, Ingrid Steinkoenig: None declared, Maarten de Wit Consultant of: AbbVie, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, Roche, Danielle van der Windt: None declared, Arthur Kavanaugh Speakers bureau: AbbVie, Amgen, BMS, Eli Lilly, Gilead Janssen, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, BMS, Eli Lilly, Gilead Janssen, Novartis, Pfizer, UCB

Offspring of systemic lupus erythematosus (SLE) patients delivered during follow-up in the lupus clinic from 1973 to 1998 were assessed for SLE and by age-appropriate neurocognitive tests. Nine domains were evaluated. Controls, matched for age, sex, race and socio-economic status, underwent the same neurodevelopmental/neuropsychological evaluation. A domain was considered 'abnormal' if at least one of the tests in the domain yielded abnormal results. The number of offspring with normal/abnormal results was compared in each of the nine domains using McNemar test for matched analysis. In addition, an unmatched analysis using chi-square tests was performed. Logistic regression was run on both the matched pairs and unmatched groups to adjust for possible gender differences. A total of 106 children, 49 pairs of SLE offspring and matched controls (20 male and 29 female) and an extra eight offspring (three male and five female) of SLE patients without a control match were included. Of the 57 SLE offspring, none were diagnosed with SLE. The matched analyses of the neuropsychological domains revealed impairment in SLE children compared with matched controls in two of the nine domains: learning and memory and behaviour.

Objectives Safety, efficacy, & radiographic progression in GLM-treated pts from long-term extension of GO-REVEAL is presented. Methods 405 PsA pts (≥3 SJ, ≥3 TJ counts) were rand to SC PBO (Grp1, n=113), GLM50mg (Grp2, n=146), or GLM100mg (Grp3, n=146) q4wks thru wk20. Concomitant MTX at baseline (BL) was allowed but not required. At wk16, pts with <10% improvement in SJ&TJ were eligible for rescue tx. All pts received GLM from wk24 forward. After wk52, pts could change GLM dose based on investigator judgment. The last GLM inj was at wk252; efficacy was assessed at wk256 based on rand grp&completer analyses using ACR response criteria, DAS28-CRP, PASI, HAQ, enthesitis/dactylitis assessments, NAPSI scores, & PsA-modified Sharp/van der Heijde Score (SHS). Safety evaluations included all pts who received at least one GLM dose thru 5yrs. Results Of 405 pts rand, 335 cont’d in the study at wk104, & 279 pts (69%) cont’d GLM thru wk252. 29% of Grp2 pts dose escalated to GLM100mg; 25% of Grp3 pts decreased dose from 100mg to 50mg. BL characteristics of pts who cont’d in the study at wk104 & efficacy at wk256 are provided(Table). ACR&PASI responses were similar in pts tx with or without MTX; changes from BL in SHS scores were minimal&numerically less in pts tx with GLM & MTXvs GLM alone. 88%, & 21% GLM-tx pts experienced AE & SAE, resp. 12% of pts d/c GLM due to AE, & 5% & 4% pts experienced malignancy (incl NMSC),& serious infection, resp. Antibodies to GLM were detected in 6% of pts. Conclusions Pt attrition thru 5yrs of GLM tx was low. GLM tx resulted in long-term maintenance of clinically meaningful responses in arthritic & skin components of PsA, improved physical function, & arrest of radiographic progression. No apparent differences between long-term safety&efficacy of 2 GLM doses administered q4wks were observed, however, interpretation of the data is limited due to tx changes allowed across rand grps. Disclosure of Interest A. Kavanaugh Grant/research support from: Janssen Research and Development, LLC, D. van der Heijde Grant/research support from: Janssen Research and Development, LLC, I. McInnes Grant/research support from: Janssen Research and Development, LLC, P. Mease Grant/research support from: Janssen Research and Development, LLC, G. G. Krueger Grant/research support from: Janssen Research and Development, LLC, D. Gladman Grant/research support from: Janssen Research and Development, LLC, Y. Zhou Employee of: Janssen Research and Development, LLC, J. D. Lu Employee of: Janssen Research and Development, LLC, Z. Xu Employee of: Janssen Research and Development, LLC, L. Noonan Employee of: Janssen Research and Development, LLC, A. Beutler Employee of: Janssen Research and Development, LLC

BackgroundTofacitinib is an oral Janus kinase inhibitor under investigation for treatment of PsA.ObjectivesEvaluation of efficacy and safety of tofacitinib vs placebo (PBO) in adult patients (pts) with active PsA and an inadequate response (IR) to TNF inhibitors (TNFi).MethodsEligible pts in this 6-month, randomised, PBO-controlled, double-blind, multicentre, Phase 3 study had ≥6 months' PsA diagnosis, met CASPAR criteria, had active arthritis (≥3 tender/painful and ≥3 swollen joints) at screening and baseline, active plaque psoriasis at screening and IR to ≥1 TNFi (discontinued due to inadequate efficacy or adverse event [AE]). Pts were randomised 2:2:1:1 to tofacitinib 5 mg twice daily (BID), tofacitinib 10 mg BID or PBO (advancing to tofacitinib 5 or 10 mg BID in a blinded manner at Month [M]3). Ongoing treatment with 1 conventional synthetic DMARD was required. Pts were followed through M6. Primary endpoints were ACR20 response rate and change (Δ) from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at M3.ResultsPts were 92.1% white, 55.3% female and mean age was 50.0 years. At baseline, mean swollen and tender/painful joint counts were 22.0 and 11.8 respectively; mean HAQ-DI score was 1.3; 69.8% of pts had LEI >0; 49.2% had Dactylitis Severity Score (DSS) >0. Most patients (62.7%) had ≥3% BSA affected by psoriasis, for whom median PASI score was 7.9. Discontinuation rate at M3 was 7.6%, and 87.6% completed M6. ACR20 response and ΔHAQ-DI significantly improved with both tofacitinib doses vs PBO at M3 (Fig 1A,B) and were maintained to M6 (Fig 1C,D). Tofacitinib 5 mg and 10 mg BID demonstrated superior ACR20 response vs PBO as early as Week 2 (26.7% [p≤0.05] and 28.8% [p≤0.05] vs 13.0%). Secondary endpoints at M3 for tofacitinib 5 mg and 10 mg respectively were: ACR50 response, 29.8% (p≤0.05), 28.0% (p≤0.05); ACR70 response, 16.8% (not significant [NS]), 14.4% (NS); ≥75% improvement of PASI in pts with baseline BSA ≥3% and PASI >0, 21.3% (NS), 43.2% (p<0.0001); ΔLEI and ΔDSS in pts with baseline score >0: ΔLEI, -1.3 (p≤0.05) and -1.3 (p≤0.05) (least squares mean [LSM]); ΔDSS, -5.2 (p≤0.05) and -5.4 (p≤0.05) (LSM). Effects were maintained to M6. Frequency of serious AEs and discontinuations due to AEs was low and similar across treatment groups (Fig 1E). The most common AEs were upper respiratory tract infection (5.3–10.8%), nasopharyngitis (1.5–10.7%) and headache (4.5–9.1%).ConclusionsIn this study restricted to PsA pts with TNFi-IR, both tofacitinib doses appeared efficacious on musculoskeletal endpoints for treatment of PsA. No new safety risks were identified vs previous studies in other indications.AcknowledgementsPreviously presented at ACR 2016, to be presented at AAD 2017 and reproduced with permissions. This study was sponsored by Pfizer Inc. Editorial support was provided by AG McCluskey of CMC and was funded by Pfizer Inc.Disclosure of InterestD. Gladman Grant/research support from: Amgen, AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Pfizer Inc, Novartis, UCB, Consu...

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BackgroundTofacitinib is an oral Janus kinase inhibitor under investigation for treatment of psoriatic arthritis (PsA). The safety and efficacy of tofacitinib for the treatment of PsA has been investigated in two Phase 3 randomised controlled trials (RCTs: OPAL Broaden [12 months; NCT01877668]; OPAL Beyond [6 months; NCT01882439]).ObjectivesTo evaluate patient-reported outcomes (PROs) in patients (pts) with active PsA enrolled in OPAL Broaden (N=422) and OPAL Beyond (N=394). OPAL Broaden pts had an inadequate response (IR) to ≥1 conventional synthetic disease-modifying antirheumatic drug and were naïve to tumour necrosis factor inhibitors (TNFi) whilst OPAL Beyond pts had an IR to ≥1 TNFi.MethodsPts were randomised to tofacitinib 5 mg twice daily (BID), tofacitinib 10 mg BID, placebo (PBO)→ tofacitinib 5 mg BID, PBO→ tofacitinib 10 mg BID and, in OPAL Broaden, also to adalimumab 40 mg subcutaneously every two weeks (active comparator). Pts receiving PBO advanced to either tofacitinib 5 mg BID or 10 mg BID at month 3 (M3) in both RCTs. Least squares mean changes from baseline in: Patient's Global Assessment of Arthritis (PtGA; Visual Analogue Scale [VAS]); Arthritis Pain (Pain; VAS); Short Form-36 Health Survey (SF-36); Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F); Dermatology Life Quality Index (DLQI) and Ankylosing Spondylitis Quality of Life (ASQOL) questionnaires are reported. Nominal p values are reported without adjustments for multiple comparisons.ResultsPatients with active PsA in OPAL Broaden and OPAL Beyond RCTs receiving tofacitinib 5 mg and 10 mg BID reported improved PROs compared with PBO (Table 1). Greater improvements in PtGA and Arthritis Pain were observed as early as Week 2 through M3 with both tofacitinib doses compared with PBO in both studies (p≤0.05). Greater improvements were also reported in SF-36 Physical Component Summary, DLQI and ASQOL scores at M1 and M3 with both tofacitinib doses compared with PBO (p≤0.05). There were greater improvements in SF-36 physical functioning, bodily pain and vitality domains with both tofacitinib doses compared with PBO in both studies (p≤0.05) at M3. SF-36 social functioning domain showed greater improvement with tofacitinib 5 mg BID in OPAL Broaden and both tofacitinib doses in OPAL Beyond compared with PBO at M3 (p≤0.05). SF-36 role-physical domain showed greater improvement with tofacitinib 10 mg BID in OPAL Beyond at M3 compared with PBO (p≤0.05). FACIT-F showed a greater improvement in both studies at M3 with both tofacitinib doses compared with PBO (p≤0.05). In OPAL Broaden, improvements in PROs were similar between tofacitinib and adalimumab.ConclusionsPts with active PsA receiving tofacitinib reported greater improvements in PROs compared with PBO at M3 that were maintained throughout both RCTs.AcknowledgementsTo be presented at AAD 2017 and reproduced with permission. This study was sponsored by Pfizer Inc. Editorial support was provided by S. Morgan of CMC and was funded by Pfizer Inc.Disclosure of InterestV. Strand Consulta...

BackgroundThe RAPID-PsA trial (NCT01087788) has investigated the efficacy and safety of certolizumab pegol (CZP) for the treatment of patients (pts) with psoriatic arthritis (PsA). Previous reports have demonstrated CZP to be safe and efficacious over 96 weeks (wks) of treatment.1ObjectivesTo report 4-year efficacy and safety data from the RAPID-PsA trial of CZP in PsA pts.MethodsRAPID-PsA was double-blind and placebo-controlled to Wk24, dose-blind to Wk48 and open-label (OL) to Wk216. Pts had active PsA and had failed ≥1 DMARD. Pts originally randomized to CZP (200mg Q2W or 400mg Q4W, following 400mg loading dose at Wks 0, 2, 4) continued on their assigned dose in the OL period. Outcomes assessed included: ACR20/50/70 and PASI75/90 responses, minimal disease activity (MDA), HAQ-DI, pain and patient's global assessment of disease activity (PGADA). Efficacy data are presented for all pts originally randomized to CZP. Data are shown as observed case and with imputation: NRI for categorical and LOCF for continuous measures. The safety set consisted of all pts treated with ≥1 dose of CZP to Wk216.Results409 pts were randomized, of whom 273 received CZP from Wk0. Of CZP-randomized pts, 91% completed to Wk24, 87% to Wk48 and 67% to Wk216. In the OL period, 17 pts (6.2%) withdrew due to an adverse event (AE) and 5 pts (1.8%) due to loss of efficacy.ACR responses were sustained in both dose regimens from Wk24 to Wk216 (Table A). In those 166 CZP pts (60.8%) with ≥3% body surface area skin involvement at baseline (BL), PASI75/90/100 responses were maintained to Wk216 (Table A). Improvements in patient-reported outcomes were also maintained through Wk216 (Table B). Pts had further improvements from Wk24 to Wk216 in high-threshold outcomes (ACR70, MDA and PASI100) when either observed case or conservative imputation methods (NRI) were used (Table A).Pts in the safety set (N=393) had total CZP exposure of 1321 patient-years (PY) with an AE rate (ER) per 100 PY of 258.0. No new safety signals were identified from Wk96 to Wk204, and no additional deaths were reported.ConclusionsCZP efficacy was maintained in PsA pts over 4 years of treatment, with no new safety signals identified. Additional improvements in high-threshold outcomes were seen from Wk24 to Wk216.ReferencesMease P. RMD Open 2015;1:e000119AcknowledgementThe authors acknowledge Costello Medical Consulting, funded by UCB Pharma, for writing and editorial assistance.Disclosure of InterestP. Mease Grant/research support from: AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer and UCB Pharma, Consultant for: AbbVie, Amgen, BiogenIdec, BMS, Celgene, Covagen, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer and UCB Pharma, Speakers bureau: AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Pfizer and UCB Pharma, R. Fleischmann Grant/research support from: Genetech Inc, Roche, Abbott, Amgen, UCB Pharma, Pfizer, BMS, Lilly, Sanofi-Aventis, MSD, Novartis, AstraZeneca and Janssen, Cons...