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Background: Tumor necrosis factor inhibitors (TNFi) are frequently chosen as the first biologic for patients with psoriatic arthritis (PsA). Given that many patients with PsA are TNFi inadequate responders (TNF-IR; either inadequate efficacy or intolerance), treatments utilizing alternative mechanisms of action are needed. In phase 3 studies, the fully human interleukin (IL)-23p19 subunit-inhibitor, guselkumab, was efficacious in patients with active PsA, including TNFi-IR. Efficacy was generally consistent between TNFi-naïve and TNFi-experienced cohorts; however, in the latter, higher response rates have been observed with the Q4W dosing regimen relative to the Q8W dosing regimen for some endpoints, suggesting the need to evaluate whether more frequent dosing may provide an incremental clinical benefit for TNFi-IR patients., Methods: The phase 3b SOLSTICE study will assess guselkumab efficacy and safety in TNFi-IR PsA patients. Eligibility criteria include a PsA diagnosis for ≥ 6 months; active disease (≥ 3 swollen, ≥ 3 tender joints, C-reactive protein ≥ 0.3 mg/dL); and inadequate efficacy with, and/or intolerance to, one prior TNFi. Participants will be randomized 1:1:1 to guselkumab Q4W or Q8W or placebo→guselkumab Q4W (at Week 24). The primary endpoint is the proportion of patients achieving ≥ 20% improvement in the American College of Rheumatology criteria (ACR20) at Week 24. Major secondary endpoints include ACR50, ACR70; an Investigator's Global Assessment (IGA) of psoriasis score of 0/1 plus ≥ 2-grade reduction and ≥ 90% improvement in Psoriasis Area and Severity Index (both among patients with ≥ 3% body surface area affected by psoriasis and baseline IGA ≥ 2); minimal/very low disease activity; and changes from baseline in Health Assessment Questionnaire-Disability Index, the 36-item Short-Form Health Survey Physical Component Summary, and Functional Assessment of Chronic Illness Therapy-Fatigue scores. The target sample size (N = 450) is estimated to provide > 90% power in detecting differences between each guselkumab group and the placebo group for the primary endpoint assuming a 2-sided α = 0.05. Cochran-Mantel-Haenszel testing and analyses of covariance will be used to compare efficacy for binary and continuous endpoints, respectively., Discussion: Findings from the phase 3b SOLSTICE study, the design of which was informed by results from previously conducted phase 3 studies, is expected to provide important efficacy and safety information on guselkumab therapy in TNFi-IR patients with PsA., Trial Registration: This trial was registered at ClinicalTrials.gov, NCT04936308, on 23 June 2021., (© 2024. The Author(s).)

Background: The Psoriasis Longitudinal Assessment and Registry (PSOLAR) is a global, prospective, longitudinal, disease-based registry. It serves as a post-marketing safety commitment with a focus on patients with moderate to severe plaque psoriasis who are candidates for systemic therapy., Objectives: To describe the baseline disease demographics and clinical characteristics of a Canadian subgroup of participants enrolled in PSOLAR., Methods: Baseline demographic/disease characteristics, medical histories, and previous psoriasis treatments for Canadian patients in PSOLAR were summarized using descriptive statistics., Results: There were 1896 patients analyzed in the Canadian subgroup at 37 clinical sites, accounting for 15.7% of the global PSOLAR population. Baseline disease and clinical characteristics were as expected for a moderate to severe psoriasis population and were generally similar to the global PSOLAR population. Two distinctions were noted in the Canadian subgroup versus those enrolled globally: a higher proportion of patients were overweight/obese (84.7% vs. 80.4%) and male (61.4% vs. 54.7%). In addition, the Canadian subgroup had numerically higher historical peak disease activity (PGA score 3.35 vs. 3.1) and longer disease duration (22.3 years vs. 17.5 years). Canadian PSOLAR patients reported a variety of comorbidities, including psoriatic arthritis (31.5%), hypertension (34.6%), hyperlipidemia (24.3%), mental illness (24.1%), and inflammatory bowel disease (1.6%)., Conclusion: The Canadian subgroup of PSOLAR patients was generally similar to those enrolled globally with respect to baseline disease demographics and clinical characteristics. Multiple comorbidities are noted in the Canadian subgroup, underscoring the need for a holistic approach to the treatment of psoriatic patients., Competing Interests: Declaration of Conflicting InterestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: MJG: Consultant, speaker and/or advisory boards for AbbVie, Akros Pharma, Amgen, Arcutis, Aslan, Aristea, AnaptysBio, Boehringer Ingelheim, BMS, Celgene, Dermira, Dermavant, Eli Lilly and Company, Galderma SA, GSK, Incyte, Janssen, Kyowa Kirin, Leo Pharma, MedImmune, Merck, Moonlake, Meiji, Nimbus, Novartis, Pfizer, Regeneron, Reistone, Roche, Sanofi Genzyme, and UCB; RB: Advisory Board Member, Consultant, Speaker and/or Investigator for and received honoraria and/or grants from, AbbVie, Alumis, Amgen, AnaptysBio, Bausch Health, Boston, BMS/Celgene, Dermavant, Eli Lilly, Janssen, LEO Pharma, Nimbus, Novartis, Pfizer, Regeneron, UCB, VentyxBio and Xencor. R Bissonnette is also an employee and shareholder of Innovaderm Research; SK: Consultant, speaker or advisory boards for AbbVie, Actelion Pharmaceuticals, Amgen, Boehringer Ingelheim, BMS, Celgene, Eli Lilly and Company, Galderma SA, GSK, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, UCB, and Valeant Pharmaceutical; KAP: Receive honoraria and/ or clinical research grants as a consultant, speaker, scientific officer, steering committee member, and/or advisory board member for 3M, AbbVie, Akesis, Akros, Alza, Amgen, Astellas, Baxter, Boehringer Ingelheim, Celgene, Centocor, Cipher, Eli Lilly, Forward Pharma, Funxional Therapeutics, Galderma, Glaxo Smith Kline, Isotechnika, Janssen, Janssen Biotech, Kirin, Kyowa, Lypanosys, Merck-Serono, Merck Sharpe Dome, Mitsubishi Pharma, Novartis, Pfizer, Takeda, UCB, Vertex, and/ or Wyeth; LCG: Consultant, speaker, and received grants for clinical research from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Leo Pharma, Merck, Novartis, Pfizer, and Valeant; speaker and consultant for Aralez; consultant and received grants for clinical research from Bristol-Meyers Squibb, and received grants for clinical research from Boehringer Ingelheim and UCB. WPG: grants/research support from AbbVie, Amgen, Eli Lilly, Novartis, Pfizer; honoraria for ad boards/invited talks/consultation from AbbVie, Actelion, Amgen, Arylide, Bausch Health, Boehringer, Celgene, Cipher, Eli Lilly, Galderma, Janssen, LEO Pharma, Merck, Novartis, PeerVoice, Pfizer, Sanofi-Genzyme, Tribute, UCB, Valeant; and clinical trials (study fees) from AbbVie, Asana Biosciences, Astellas, Boerhinger-Ingleheim, Celgene, Corrona/National Psoriasis Foundation, Devonian, Eli Lilly, Galapagos, Galderma, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, UCB.>.; VH: Consultant, speaker or advisory boards for Abbvie, Eli Lilly, Janssen, and Novartis; NHS: Consultant for AbbVie, Bausch Medicine, Celgene, Janssen, Leo Pharma, Lilly, Novartis, Sanofi Genzyme; RV: Consultant, speaker and/or advisory boards for AbbVie, Actelion Pharmaceuticals, Amgen, Boehringer Ingelheim, BMS, Celgene, Dermira, Eli Lilly and Company, Galderma SA, GSK, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, UCB, and Valeant Pharmaceutical; RG: clinical trials for AbbVie, Bausch Health, and Janssen and has received honoraria as consultant and/or speaker from AbbVie, Bausch Health, Eli Lilly, Janssen, Kyowa Kirin, Mallinckrodt, Novartis, Sun Pharma and Sanofi; VHP: Consultant, speaker and/or advisory boards for AbbVie, Actelion, Amgen, AnaptysBio, Aralez, Arcutis, Aspen, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Cipher, Eli Lilly, Galderma, GlaxoSmithKline, Homeocan, Incyte, Janssen, LEO Pharma, L’Oreal, Medexus, Novartis, Pediapharm, Pfizer, Sanofi Genzyme, Sun Pharma, Tribute, UCB Pharma, and Valeant; investigator for AbbVie, Amgen, Arcutis, Arena, Asana, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Concert, Dermavant, Dermira, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Nimbus Lakshmi, Novartis, Pfizer, Regeneron, Reistone, Sanofi Genzyme, UCB Pharma, and Valeant; received educational grants from AbbVie, Bausch Health, Celgene, Janssen, LEO Pharma, Novartis, Sanofi Genzyme, and Valeant; IT: Consultant, speaker or investigator for Abbvie, Amgen, Arcutis, Aristea, Bausch Health, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Galderma, Incyte, Janssen, Kiniksa, LeoPharma, Mallinckrodt, Novartis, Pfizer, Sanofi, SunPharma, UCB; WL, KP, SDS, NA and OL: Employee of either Janssen Research & Development or Janssen Inc. Canada; RA: Consultant, speaker or advisory boards for Abbvie, Amgen, Boehringer Ingelheim, Eli Lilly and Company, Galderma, Janssen, Leo Pharma, Novartis, Pfizer, Sandoz, Sanofi, Sun pharma, and UCB.

Introduction: To assess changes in the Patient-Reported Outcomes Measurement Information System (PROMIS ® ) outcomes related to social, mental, and physical well-being after approximately 1 year of intravenous (IV) golimumab or infliximab treatment in patients with rheumatoid arthritis (RA) using real-world evidence from AWARE., Methods: AWARE was a prospective, noninterventional, multicenter, observational, U.S.-based phase 4 study of 1270 RA patients who initiated treatment with IV golimumab or infliximab. PROMIS-29 and PROMIS short form (SF) Fatigue 7a and Pain Interference 6b questionnaires were administered at baseline and infusions 2, 5, and 8 (approximately weeks  4, 28, and 52 for IV golimumab and weeks  2, 22, and 46 for infliximab). Mean changes from baseline in all PROMIS-29 domains and respective SFs and response rates for achieving ≥ 3, ≥ 5, or ≥ 10-point improvements were determined., Results: Among all patients, baseline mean ± SD PROMIS T-scores were consistent between treatment groups and indicated worse physical function (38.2 ± 6.8 IV golimumab, 38.0 ± 6.9 infliximab), more pain interference (63.0 ± 7.6 IV golimumab, 63.9 ± 7.8 infliximab), and greater fatigue (58.4 ± 9.9 IV golimumab, 59.4 ± 10.0 infliximab) in these patients vs the general U.S. population (T-score = 50). Through the 8th infusion of either treatment, IV golimumab- and infliximab-treated patients achieved meaningful improvements (≥ 3-point improvement in T-scores) in all PROMIS-29 domains and respective SFs, and the proportions of patients with ≥ 3, ≥ 5, or ≥ 10-point improvements in T-scores increased from infusion 2 through infusion 8., Conclusions: RA patients treated with IV golimumab or infliximab achieved comparable improvements across social, mental, and physical well-being PROMIS measures. Additionally, PROMIS detected meaningful clinical changes in patient-reported outcomes in both treatment groups., Gov Registration Number: NCT02728934., (© 2023. The Author(s).)

Background: Biologic therapies are often prescribed for patients with rheumatoid arthritis (RA) who have inadequate responses to or are intolerant of methotrexate (MTX) and patients with poor prognostic indicators. This post hoc analysis evaluated effectiveness and safety of intravenous golimumab + MTX vs golimumab without MTX in RA patients., Methods: AWARE, a real-world, prospective and pragmatic, Phase 4 study, compared effectiveness and safety of golimumab and infliximab in biologic-naïve and biologic-experienced patients. All treatment decisions were at the discretion of the treating rheumatologist. Effectiveness was evaluated by mean change in CDAI scores at Months 6 and 12. Safety was monitored through approximately 1 year., Results: Among 685 golimumab-treated patients, 420 (61%) received concomitant MTX during the study and 265 (39%) did not receive MTX after enrollment; 63% and 72%, respectively, discontinued the study. Relative to golimumab without MTX, golimumab + MTX patients had shorter mean disease duration (8.7 vs 10.0 years) and a lower proportion received prior biologics (60% vs 72%); mean ± standard deviation (SD) baseline CDAI scores were similar (30.8 ± 15.1 and 32.6 ± 15.4). Mean ± SD changes from baseline in CDAI scores at Months 6 and 12, respectively, were similar with golimumab + MTX (- 10.2 ± 14.2 and - 10.8 ± 13.8) and golimumab without MTX (- 9.6 ± 12.9 and - 9.9 ± 13.1). The incidence of adverse events/100 patient-years (PY) (95% confidence interval [CI]) was 155.6 (145.6, 166.1) for golimumab + MTX and 191.2 (176.2, 207.1) for golimumab without MTX; infections were the most common type. The incidence of infusion reactions/100PY (95% CI) was 2.1 (1.1, 3.6) for golimumab + MTX versus 5.1 (2.9, 8.3) for golimumab without MTX; none were considered serious. For golimumab + MTX versus golimumab without MTX, rates/100PY (95% CI) of serious infections, opportunistic infections, and malignancies were 2.6 (1.5, 4.3) versus 7.0 (4.4, 10.6), 0.9 (0.3, 2.0) versus 2.6 (1.1, 5.0), and 3.0 (1.7, 4.7) versus 1.0 (0.2, 2.8), respectively., Conclusions: Mean change in CDAI score in the  golimumab without MTX group was generally similar to that of the golimumab + MTX group through 1 year, regardless of prior biologic therapy. Adverse events were consistent with the known IV golimumab safety profile. These results provide real world evidential data that may assist healthcare providers and patients with RA in making informed treatment decisions., Trial Registration: clinicaltrials.gov NCT02728934 05/04/2016., (© 2023. The Author(s).)

Objective: Patient-reported outcome (PRO) data have assumed increasing importance in the care of patients with rheumatoid arthritis (RA), yet physician-derived disease activity measures, such as Clinical Disease Activity Index (CDAI), remain the most accepted metrics to assess disease activity. The possibility that newer longitudinal PRO data might be used as a proxy for the CDAI has not been evaluated., Methods: Using data from a large pragmatic trial, we evaluated patients with RA initiating golimumab intravenous or infliximab. The classification target was low disease activity (LDA) (CDAI ≤10) at the first visit between months 3 and 12. Data were randomly partitioned into training (80%) and test (20%) data sets. Multiple machine learning (ML) methods (eg, random forests, gradient boosting, support vector machines) were used to classify CDAI disease activity category, conduct feature selection, and assess feature importance. Model performance evaluated cross-validated error, comparing different ML approaches using both training and test data., Results: A total of 494 patients were analyzed, and 36.4% achieved LDA. The most important classification features included several Patient-Reported Outcomes Measurement Information System measures (social participation, pain interference, pain intensity, and physical function), patient global, and baseline CDAI. Among all ML methods, random forests performed best. Overall model accuracy and positive predictive values for all ML methods were approximately 80%., Conclusion: ML methods coupled with longitudinal PRO data appear useful and can achieve reasonable accuracy in classifying LDA among patients starting a new biologic. This approach has promise for real-world evidence generation in the common circumstance when physician-derived disease activity data are not available yet PRO measures are., (© 2022 The Authors. ACR Open Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)

Background: Patterns of psoriasis characteristics by sex are not fully understood. Objective: Evaluate patient characteristics by sex at enrollment in the Psoriasis Longitudinal Assessment and Registry (PSOLAR). Methods: Two PSOLAR cohorts were evaluated by sex: patients who were biologic-naïve (n = 3329) and patients who were systemic therapy-naïve (n = 1290) at entry. Baseline demographic and disease characteristics, medical history, social activity, and lifestyle risk factors were collected for all patients and were compared between males and females using an independent samples t-test for continuous variables and chi-square tests for categorical variables. Results: In both cohorts, disease duration was similar for males and females; however, disease severity based on baseline Physician Global Assessment and body surface area of psoriasis was greater in males versus females ( P < .05). Baseline Dermatology Life Quality Index scores were higher for biologic-naïve females than for males ( P = .008). In both cohorts, females were significantly more likely than males to have a history of anxiety, depression, and cancer excluding nonmelanoma skin cancer, to have received systemic steroid therapy, and to have health insurance; males were significantly more likely than females to have a history of cardiovascular disease, smoking, and alcohol consumption, and to work full time. Conclusions: Based on patient data obtained at entry into PSOLAR, significant differences in psoriasis disease characteristics, and medical, family, and social history-related variables were observed between males and females. Among systemic therapy-naïve patients, there was a greater negative impact on quality of life for females compared with males, despite generally lower objective disease severity for females., Competing Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: S.G. has nothing to disclose. R.C. has nothing to disclose. W.L. is employed by Janssen Research & Development, LLC and owns stock in Johnson & Johnson, of which Janssen is a subsidiary. K.P.L. is employed by Janssen Scientific Affairs, LLC and owns stock in Johnson & Johnson, of which Janssen is a subsidiary. M.G. has been an investigator, speaker, consultant, or advisory board member for AbbVie, Actelion, Akros, Amgen, Arcutis, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dermavant, Dermira, Galderma, GSK, Eli Lilly, Incyte, Janssen, Kyowa Kirin, Leo Pharma, Medimmune, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, UCB, and Valeant/Bausch. E.M.G.J.dJ. has received research grants from AbbVie, Novartis, Janssen Pharmaceutica, Leo Pharma, and UCB, and has acted as consultant and/or paid speaker for and/or participated in research sponsored by companies that manufacture drugs used for the treatment of psoriasis including AbbVie, Almirall, Janssen Pharmaceutica, Novartis, Lilly, Celgene, Leo Pharma, Sanofi, UCB, and Galapagos. Funding received by E.M.G.J.dJ. is not personal but goes to the independent research fund of the Department of Dermatology of the Radboud University Medical Center, Nijmegen, the Netherlands. B.S. serves as a consultant for AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene Corporation, Dermavant, Eli Lilly, GlaxoSmithKline, Immunic Therapeutics, Janssen, LEO Pharma, Maruho, Meiji Seika Pharma, Mindera, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi-Genzyme, Sun Pharma, and UCB Pharma; a paid speaker for AbbVie, Eli Lilly, Janssen, and Sanofi-Genzyme/Regeneron; receives a consulting fee as a co-scientific director for the CorEvitas Psoriasis Registry; and an investigator for AbbVie, Cara, CorEvitas Psoriasis Registry, Dermavant, Dermira and Novartis., (© The Author(s) 2022.)

Objective: Evaluate tolerability and effectiveness of golimumab-IV versus infliximab in patients with rheumatoid arthritis (RA) in a real-world setting., Methods: AWARE, a prospective, real-world, pragmatic, observational, multicenter, phase 4 study, enrolled RA patients when initiating golimumab-IV or infliximab. Treatment decisions were made by the treating rheumatologist. The approved doses for RA are 2 mg/kg at weeks 0, 4, then Q8W for golimumab-IV and 3 mg/kg at weeks 0, 2, 6, then Q8W (dose escalation permitted) for infliximab. A prespecified formal interim analysis was conducted. The primary endpoint was the incidence of infusion reactions (any adverse event that occurred during or within 1 h of infusion) through week 52. Major secondary endpoints were mean change from baseline in CDAI at months 6 and 12 in biologic-naïve patients (non-inferiority margin in the CDAI = 6). Baseline characteristics were adjusted using propensity scores with inverse probability of treatment weights (IPTW)., Results: In the formal interim analysis (golimumab-IV, n = 479; infliximab, n = 354), the incidence of infusion reactions was significantly lower with golimumab-IV vs. infliximab (3.6 vs. 17.6%, p < 0.001, IPTW-adjusted). Among biologic-naïve patients, mean changes from baseline in CDAI at month 6 (- 9.5 golimumab-IV vs. - 10.1 infliximab) and at month 12 (- 9.4 golimumab-IV vs. - 10.1 infliximab) demonstrated non-inferiority., Conclusions: The proportion of patients with an infusion reaction was significantly lower with golimumab-IV vs. infliximab. Among biologic-naïve patients, mean change from baseline in CDAI at months 6 and 12 was non-inferior for golimumab-IV vs. infliximab. Compared with fixed-dose golimumab-IV, infliximab dose escalation did not provide any greater improvements in CDAI for patients with RA., Trial Registration: ClinicalTrials.gov identifier, NCT02728934., (© 2021. The Author(s).)

Introduction: Psoriasis Longitudinal Assessment and Registry (PSOLAR) was designed in 2007 as the first disease-based registry for patients with psoriasis., Objective: The aim of this study was to discuss methodological limitations and post hoc analyses in long-term safety registries using learnings from analyses of a potential safety risk for major adverse cardiovascular events (MACE) in PSOLAR., Methods: PSOLAR is an international observational study of over 12,000 psoriasis patients that was conducted to meet postmarketing safety commitments for infliximab and ustekinumab. A recent annual review of registry data indicated a potential MACE risk for ustekinumab vs. non-biologics based on prespecified COX model regression analyses, which yielded an adjusted hazard ratio (HR) of 1.533 (95% confidence interval [CI] 1.103-2.131). Therefore, we conducted a comprehensive review of key statistical methodology and implemented post hoc analytical methods to address specific limitations., Results: The following limiting factors were identified: (1) inclusion of both prevalent and incident (new) users of biologics; (2) unanticipated imbalances in patient characteristics between treatment cohorts at baseline; (3) limited availability of relevant clinical data after enrollment; and (4) divergence of characteristics associated with outcomes among comparator groups over time. The analysis was modified to include only incident users, propensity scores were used to weight HRs, and adalimumab was deemed a more clinically appropriate comparator. The revised HR was 0.820 (95% CI 0.532-1.265), indicating no meaningful increase in MACE risk for ustekinumab., Conclusion: Our results, which do not support a causal association between ustekinumab exposure and MACE risk, underscore the need for ongoing assessment of analytical methods in long-term observational studies.

Importance: Prospective data are limited on pregnancy outcomes among women with psoriasis who may be receiving biologic or conventional systemic therapy., Objective: To report pregnancy outcomes observed in the Psoriasis Longitudinal Assessment and Registry (PSOLAR)., Design, Setting, and Participants: This cohort study used data from PSOLAR, a multicenter, disease-based, observational registry evaluating long-term safety and clinical outcomes for patients receiving or eligible to receive treatment for psoriasis with biologics and/or conventional systemic therapies. Of 12 090 enrollees, 5456 were women (45.1%), and 2224 women were of childbearing age (18-45 years). Participants had a total of 12 929 patient-years of follow-up (median, 7.2 [range, 3.3-8.0] years per patient). Data were collected from June 20, 2007, to August 23, 2019, and analyzed from April 23 to June 23, 2020., Exposures: Exposure to biologics within the prenatal period (≤1 year before birth or ≤6 months before spontaneous abortion) or at any other time., Main Outcomes and Measures: Descriptive summaries of pregnancies and pregnancy-related outcomes were self-reported in PSOLAR, including births, stillbirths, spontaneous abortions, and elective terminations. Live birth characteristics collected in PSOLAR include whether a birth was full-term (≥37 weeks) or premature (<37 weeks) and whether neonatal adverse events or congenital anomalies occurred., Results: A total of 298 pregnancies occurred among 220 women (mean [SD] age, 27.8 [5.2] years), and the general fertility rate was 18.9 per 1000 women aged 18 to 45 years. Of the 298 pregnancies, 244 (81.9%) resulted in birth, 41 (13.8%) ended in spontaneous abortion, and 13 (4.4%) were electively terminated. Gestational age was available for 243 births; 221 infants (90.9%) were full-term, and 22 (9.1%) were born prematurely. Birth outcomes included 231 healthy newborns, 10 infants with a neonatal problem, 2 infants with a congenital anomaly, and 1 stillbirth. Of the 298 pregnancies, 252 were associated with biologic exposure before or during pregnancy. Pregnancy outcomes for women exposed to biologics were similar to those for women exposed to nonbiologics. Among women who became pregnant, mean (SD) age at the time of pregnancy outcome was 30.9 (4.8) years; at enrollment into the registry, 74 of 219 (33.8%) had obesity, and 121 of 220 (55.0%) were past or current smokers., Conclusions and Relevance: The findings of this cohort study suggest that pregnancy outcomes in PSOLAR have remained consistent with previous reports. Overall and live birth outcomes were similar to those for the general population.

Background: The effects of systemic therapy on mortality risk among patients with psoriasis are not fully understood., Objective: To evaluate the impact of systemic treatment on mortality risk in patients enrolled in the Psoriasis Longitudinal Assessment and Registry., Methods: Nested case-control analyses were performed to estimate mortality risk. Cases were defined as patients who died while participating in the Psoriasis Longitudinal Assessment and Registry. Cases were matched (1:4) with controls by age, race, sex, and geographic region. Evaluated treatments included methotrexate, ustekinumab, and tumor necrosis factor α inhibitors. Exposure was defined as at least 1 dose of treatment within 3 months before death and was stratified by duration of therapy., Results: Among 12,090 patients, 341 deaths occurred, matched to 1364 controls. Biologic treatment within the preceding 3 months was protective against mortality versus no exposure: odds ratio (OR) for exposure of less than 1 year, 0.08 (95% confidence interval [CI], 0.03-0.23); OR for exposure of 1 year or longer, 0.09 (95% CI, 0.06-0.13). Methotrexate was protective against mortality only with exposure for 1 year or longer (OR, 0.08; 95% CI, 0.02-0.28)., Limitations: Observational studies are subject to unmeasured confounding., Conclusions: Biologic therapy was associated with reduced mortality risk in patients with moderate to severe psoriasis, regardless of treatment duration; methotrexate reduced risk only with exposure for 1 year or longer., (Copyright © 2020 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Erratum for "Evaluation of Risk of Major Adverse Cardiovascular Events with Biologic Therapy in Patients with Psoriasis." Retrieved from http://jddonline.com/articles/dermatology/S1545961617P1002X/J Drugs Dermatol&nbsp;2017;16(10):1002-1013. J Drugs Dermatol 2020;19:e28-e32.

Erratum for article "Safety surveillance for ustekinumab and other psoriasis treatments from the Psoriasis Longitudinal Assessment and Registry (PSOLAR)." Retrieved from&nbsp;https://jddonline.com/articles/dermatology/S1545961615P0706XJ Drugs Dermatol&nbsp;2015;14(7):706-714&nbsp;&nbsp;J Drugs Dermatol 2020;19:e32-e34.

Erratum for article "Safety observations in 12095 patients with psoriasis enrolled in an international registry (PSOLAR): Experience with infliximab and other systemic and biologic therapies." Retrieved from&nbsp;https://jddonline.com/articles/dermatology/S1545961614P1441XJ Drugs Dermatol 2020;19:e35-e36.

Background: Patients with psoriatic arthritis (PsA) have increased risk of adverse events, including serious infections (SI), compared with psoriasis patients., Methods: Patients eligible for, or receiving conventional systemic and biologic agents for psoriasis were followed prospectively using PSOLAR. Cohorts included: ustekinumab, tumor necrosis factor (TNF) inhibitors; infliximab; etanercept; adalimumab; non-biologic/methotrexate (MTX) (reference group); and non-biologic/non-MTX. Multivariate analyses using Cox hazard regression were used to identify factors associated with time to first SI. Rates of SI in PSOLAR psoriasis patients with self-reported PsA and possible risks with biologic therapy were evaluated., Results: PSOLAR enrolled 4315 psoriasis patients with self-reported PsA. The overall population ( N  = 2401) included patients (n): 628 ustekinumab; 1413 TNF inhibitors; 258 infliximab; 481 etanercept; 674 adalimumab; 54 other biologics, 98 non-biologic/MTX; 208 non-biologic/non-MTX. Overall, 138 SI were reported with incidence rates per 100 patient-years as follows: a) ustekinumab: 1.00; b) TNF inhibitors: 2.22; c) infliximab: 2.12; d) etanercept: 2.58; e) adalimumab: 1.99; f) non-biologic/MTX: 3.01; g) and non-biologic/non-MTX: 2.31. Age, time-dependent disease activity Physician's Global Assessment (PGA) of 4, 5, history of infection, and diabetes were associated with increased risk for SI ( p  < 0.05) in self-reported PsA patients. Biologic groups, other than ustekinumab, had numerically higher rates of SI., Conclusions: PSOLAR psoriasis patients with self-reported PsA in the TNF inhibitors, infliximab, adalimumab, etanercept, and MTX cohorts had numerically higher SI rates than the ustekinumab cohort, although not statistically significant. Age, PGA 4, 5, history of infection, and diabetes were associated with an increased risk for SI, irrespective of biologic exposure., Trial Registration: NCT00508547; Registered July 30, 2007., Competing Interests: Competing interestsC. T. Ritchlin has received consultant fees (< $10,000) from Amgen, Eli Lilly, Janssen, Pfizer, and UCB, and consultant fees (> $10,000) from AbbVie. M. Stahle has received consultant/speaking/honoraria (<$10,000) from AbbVie, Eli Lilly, Leo Pharma, and Novartis. Y. Poulin has received consultant/speaking/ honoraria (<$10,000) from Amgen, Celgene, and Galderma, and fees (>$10,000) from AbbVie, Eli Lilly, Janssen, and Novartis. J. Bagel has received consultant fees (<$10,000) from Boehringer Ingelheim, and consultant/speaker/investigator fees (>$10,000) from Eli Lilly, Celgene, Janssen, Leo Pharma, Novartis, and Ortho Dermatologics. A. B. Gottlieb has received consultant/speaking/honoraria (<$10,000) from Beiersdorf, Merck, Novartis, and Valeant, and (>$10,000) from AbbVie, Eli Lilly, Janssen, Pfizer, and UCB. S. D. Chakravarty, S. Kafka, B. Srivastava, and W. Langholff are all employees of Janssen and own stock in Johnson & Johnson, of which Janssen is a wholly-owned subsidiary., (© The Author(s) 2019.)

Purpose: To describe the risk of herpes zoster (HZ) in patients with psoriasis and its relation to non-biologic systemic therapies or biologic treatment. Materials and methods: Psoriasis Longitudinal Assessment and Registry (PSOLAR) is an international, prospective, registry that follows adult patients with psoriasis eligible to receive non-biologic systemic therapies or biologic therapies. Mutually exclusive therapy cohorts were defined. HZ incident rates were calculated for each therapy cohort and rates between cohorts were compared using hazard ratios (HR) adjusted for potential confounders, in new users and prevalent-exposure patients. Results: A total of 55 HZ events were identified in 10,469 patients in PSOLAR. The adjusted hazard ratio in the overall study population (new user and prevalent-exposed patients) was 2.22 (95% CI: 0.82-5.97; p  = .116) for tumor necrosis factor-α (TNF) inhibitors, 2.73 (0.98-7.58; p  = .054) for ustekinumab, and 1.04 (0.20-5.41; p  = .966) for methotrexate versus reference (combined phototherapy, systemic steroids, topical therapy, and immunomodulators other than methotrexate). Conclusions: Exposure to ustekinumab, TNF-α inhibitors, and methotrexate was not associated with a statistically significant increased risk of HZ. However, HRs were elevated for ustekinumab and TNF-α inhibitors; a larger number of HZ events would be needed to assess the presence or absence of risk.

Objective: Our objective was to compare therapeutic response among patients with early-onset psoriasis (EOP) and late-onset psoriasis (LOP) receiving adalimumab, etanercept, infliximab, ustekinumab, or methotrexate in the Psoriasis Longitudinal Assessment and Registry (PSOLAR)., Methods: Patients were grouped by age of onset: EOP (age ≤ 40 years) or LOP (age > 40 years). Repeated-measures analysis with logistic regression was used to calculate the adjusted odds ratio (AOR; adjusted for baseline characteristics) for achieving a Physician's Global Assessment score of cleared/minimal (PGA 0/1) or a percentage of body surface area involved with psoriasis < 3% (%BSA < 3) or %BSA < 1 for all patients; similar sensitivity analyses were performed for each treatment group., Results: Of 7511 patients, 5479 (72.9%) had EOP. The LOP group had a higher likelihood of achieving PGA 0/1 after treatment than did the EOP group in all patients (AOR 1.14 [95% confidence interval (CI) 1.05-1.25]; p = 0.0019); the same was true in subgroups of etanercept-treated (AOR 1.38 [95% CI 1.14-1.66]; p = 0.0010) and methotrexate-treated (AOR 1.62 [95% CI 1.16-2.26]; p = 0.0049) patients. No significant difference was found between the EOP and LOP groups with regard to the likelihood of achieving %BSA < 3 or %BSA < 1 among all patients. However, LOP patients were more likely than EOP patients to achieve %BSA < 3 or %BSA < 1 in subgroups treated with infliximab (AOR 1.45 [95% CI 1.09-1.93; p = 0.0103] and AOR 1.36 [95% CI 1.03-1.78; p = 0.0290], respectively) and etanercept (AOR 1.30 [95% CI 1.06-1.61; p = 0.0123] and AOR 1.34 [95% CI 1.09-1.64; p = 0.0053], respectively)., Conclusion: Our real-world data from PSOLAR indicate that there are differences in some patient characteristics between EOP and LOP and that patients with EOP are less likely than those with LOP to respond to certain systemic treatments. (ClinicalTrials.gov identifier: NCT00508547).