Showing papers by "Wayne Langholff published in 2020"

Fri0567 construct validation of promis short form and profile-29 t-scores with sf-36 in rheumatoid arthritis patients treated for 1 year: results from a real‑world evidence-based study in the united states

Abstract: Background: Use of patient-reported outcomes (PROs) to assess health-related quality of life in clinical practice, research studies, and clinical trials in rheumatoid arthritis (RA) remains an ongoing area of research. SF-36 is commonly used in RA trials but is not feasible for routine use in clinical practice settings. The Patient Reported Outcomes Measurement Information System (PROMIS) may address this gap but has not been widely assessed in RA patients starting therapy in a real-world comparative effectiveness study, nor examined in that setting in relation to the SF36 and Clinical Disease Activity Index (CDAI). Objectives: To assess validity of PROMIS based on Comparative and Pragmatic Study of Golimumab Intravenous (IV) Versus Infliximab in Rheumatoid Arthritis (AWARE), an ongoing Phase 4 study providing real-world assessment of IV tumor necrosis factor inhibitor (TNFi) medications in RA patients. Methods: AWARE is a prospective, non-interventional, 3-year study conducted at 88 US sites. RA patients were enrolled when initiating TNFi treatment. Treatment decisions were made by treating rheumatologists. We report baseline PROMIS-29 (7 domains and pain intensity), PROMIS Pain Interference (PI) Short Form (SF) 6b (PI6b) and PROMIS Fatigue (F) Short Form 7a (F7a), domain T-Scores, and SF-36 subdomain and Component Scores (CS) in AWARE patients. Here we report baseline data obtained from the final 1-year AWARE dataset. Correlations between PROMIS measures and comparable SF-36 component scores were calculated using Pearson correlations. Data is shown as mean ± standard deviation (SD). Results: At baseline, mean CDAI of all patients (n=1262) was 32.3±15.6, with 70.4% in high disease activity (HDA, CDAI>22), 22.8% in moderate disease activity (MDA, CDAI: >10 and ≤22), 6.1% in low disease activity (LDA, CDAI: >2.8 and ≤10), and 0.7% in remission (CDAI ≤2.8). Mean PROMIS scores were >0.5 SD worse than population means for Physical Function (PF, 38.1±6.84), PI (63.4±7.68), F (58.8±9.95), Sleep Disturbance (55.1±8.68); and Ability to Participate in Social Roles/Activities (PSRA, 43.4±8.58). Baseline Depression and Anxiety were within 0.5 SD of population T-scores. PI6b, F7a, and P29 domain T-scores correlated with the comparable SF-36 subdomain and component scores (r’s >0.58), except sleep for which no comparable SF-36 element was applicable. Examples include: P6b (r=-0.80) and P29-PI (0.81) with SF-36 Bodily Pain; F7a (-0.77) and P29-F (-0.77) with SF-36 Vitality; P29-PF with SF-36 PF (0.77), Role-Physical (0.69), and Physical CS (0.73); P29 Anxiety with SF-36 Mental Health (-0.72), Role-Emotional (-0.56), Mental CS (-0.70); and P29-PRSA with SF-36-Social Functioning (0.71). Mean PROMIS-29 T-scores (except Anxiety and Sleep Disturbance) among patients with HDA were significantly different from patients with MDA, LDA or remission (p Conclusion: Analysis of baseline results from a large cohort of RA patients indicates high correlations between individual P29 domain T-scores and SF-36 component scores, as well as categorical CDAI, providing strong evidence of PROMIS construct validity in a real-world population of RA patients. Disclosure of Interests: Clifton Bingham Grant/research support from: Bristol-Myers Squibb, Consultant of: Bristol-Myers Squibb, Shelly Kafka Employee of: Janssen Scientific Affairs, LLC, Shawn Black Employee of: Janssen Research & Development, LLC, Janssen Scientific Affairs, LLC, Stephen Xu Employee of: Janssen Research & Development, LLC, Wayne Langholff Employee of: Janssen Research & Development, LLC, Jeffrey Curtis Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, UCB, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, UCB

Sat0120 united states rheumatology practice-based real-world evidence of infusion reactions in rheumatoid arthritis patients treated with intravenous golimumab or infliximab: impact of prior biologic exposure and methotrexate utilization

Abstract: Background: AWARE (Comparative and Pragmatic Study of Golimumab IV Versus Infliximab in Rheumatoid Arthritis) is an ongoing Phase 4 comparator study designed to provide a real-world assessment of intravenous golimumab (GLM) and intravenous infliximab (IFX) in patients (pts) with rheumatoid arthritis (RA). The study recently reached its primary endpoint (comparison of overall incidence of infusion reactions in GLM- vs IFX-treated pts after 52 weeks) with the last patient reaching 52 weeks of treatment or discontinuation from the study. AWARE also records prior use of biologic medications and concomitant use of methotrexate (MTX). Objectives: To assess the incidence of infusion reactions among GLM and IFX pts reported at baseline by examining the influence of prior biologic exposure or concurrent use of MTX. Methods: AWARE is a prospective, noninterventional, observational, multicenter, 3-year study conducted in the US. RA patients (1,270 adults) were enrolled at the time of initiating treatment with GLM or IFX. All treatment decisions were made at the discretion of the treating rheumatologist. An infusion reaction was any adverse event that occurred during an infusion or within 1 hour after the infusion of either GLM or IFX. Imputations were not performed on these AWARE data. Data shown are mean ± standard deviation. Results: Demographics are shown in Table 1 and the incidence of infusion reactions in different AWARE cohorts is shown in Table 2. GLM and IFX pts were comparable in sex and utilization of MTX at baseline. Both age and disease duration of GLM pts was greater than IFX pts by ~2 years. There was a higher proportion of bionaive pts in IFX-treated group compared to GLM-treated group. Overall, infusion reactions occurred more frequently among IFX-treated pts compared to GLM-treated pts. The difference in infusion reaction rates between IFX- and GLM-treated pts was also evident among subgroups of bionaive vs non-bionaive pts, and among MTX non-users vs MTX users (characteristics reported at baseline). GLM pts did not report any serious or severe infusion reactions. These were reported rarely (3/585 pts) in IFX-treated pts. Among GLM and IFX pts with an infusion reaction, 55.6% of GLM and 77.1% of IFX pts had at least one medication for infusion reaction. Infusion reactions accounted for 9.7% and 35.1% of discontinuations due to adverse events in GLM and IFX pts, respectively. Conclusion: Whether bionaive, non-bionaive, MTX non-user or MTX user at baseline, the incidence of infusion reactions was notably lower among GLM- vs IFX-treated pts. Serious and/or severe infusion reactions did not occur among GLM pts and were rare among IFX pts. IFX was more commonly administered mediation for an infusion reaction compared to GLM. Infusion reactions accounted for almost four times the number of discontinuations related to adverse events in IFX pts compared to GLM pts. Disclosure of Interests: : Sergio Schwartzman Grant/research support from: Janssen Research & Development, LLC, Consultant of: AbbVie, Crescendo Bioscience, Dermtech, Eli Lilly and Company, Gilead Sciences, Janssen Pharmaceutica, Myriad Genetics, Novartis, Regeneron, Samsung, Sanofi, UCB, Speakers bureau: AbbVie, Eli Lilly and Company, Genentech, Janssen Pharmaceutica, Novartis, Pfizer, Regeneron, Sanofi, UCB, Aaron Broadwell Grant/research support from: Janssen Research & Development, LLC, Janssen, Eli Lilly, Consultant of: AbbVie, Amgen, AstraZeneca, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Sandoz, Speakers bureau: AbbVie, Amgen, Celgene, GSK, Horizon, Janssen, Mallinckrodt, Novartis, Pfizer, Radius, Sanofi-Regeneron, UCB, Alan Kivitz Shareholder of: AbbVie, Amgen, Gilead, GSK, Pfizer Inc, Sanofi, Consultant of: AbbVie, Boehringer Ingelheim,,Flexion, Genzyme, Gilead, Janssen, Novartis, Pfizer Inc, Regeneron, Sanofi, SUN Pharma Advanced Research, UCB, Paid instructor for: Celgene, Genzyme, Horizon, Merck, Novartis, Pfizer, Regeneron, Sanofi, Speakers bureau: AbbVie, Celgene, Flexion, Genzyme, Horizon, Merck, Novartis, Pfizer Inc, Regeneron, Sanofi, Shawn Black Employee of: Janssen Research & Development, LLC, Janssen Scientific Affairs, LLC, Stephen Xu Employee of: Janssen Research & Development, LLC, Wayne Langholff Employee of: Janssen Research & Development, LLC, Shelly Kafka Employee of: Janssen Scientific Affairs, LLC