Background Psoriatic arthritis (PsA) is a chronic immune-mediated inflammatory musculoskeletal disease, manifesting as peripheral arthritis, enthesitis, dactylitis, spondylitis, and skin and nail psoriasis. A core set of domains for measuring the impact of PsA has been developed, including pain, patient global assessment, physical function, health-related quality of life (HRQoL), and fatigue. To understand the impact of PsA on health domains from a patient’s perspective, a global survey was developed and results reported in the context of the 12-item Psoriatic Arthritis Impact of Disease (PsAID-12) questionnaire. Methods An online patient-based global survey was conducted by The Harris Poll in Australia, Brazil, Canada, France, Spain, Taiwan, the UK, and the US between November 2, 2017 and March 12, 2018. Eligible patients were ≥ 18 years old with a diagnosis of PsA for > 1 year, had visited a rheumatologist/dermatologist in the past 12 months and reported using ≥ 1 synthetic/biologic disease-modifying antirheumatic drug for PsA. Patients reported on PsA severity and symptoms, and the impact of PsA on HRQoL. After survey completion, responses were aligned with PsAID health domains. Descriptive statistics and chi-square tests were conducted. Results This analysis included 1286 patients from eight countries. Most patients (97%) reported musculoskeletal symptoms relating to PsA in the past year. Common moderate/major impacts of PsA were on physical activity (78%), ability to perform certain activities (76%), work productivity (62%), and career path (57%). Skin/nail symptoms occurred in 80% of patients. Overall, 69% of patients reported that PsA had a moderate/major impact on emotional/mental wellbeing, 56% on romantic relationships/intimacy, and 44% on relationships with family and friends. Social impacts included emotional distress (58%), social shame or disapproval (32%), and ceased participation in social activities (45%). Over half of all patients experienced unusual fatigue over the past 12 months (52%). The health domains that patients reported as being impacted by PsA aligned with life impact domains of the patient-derived PsAID health domains. Conclusion These results highlight the impact of PsA on multiple health domains from a patient perspective that should be considered during shared decision-making processes between healthcare providers and patients.

BackgroundTofacitinib is an oral Janus kinase inhibitor under investigation for psoriatic arthritis (PsA).ObjectivesTo describe the safety profile of tofacitinib from integrated Phase (P)3 and long-term extension (LTE) studies.MethodsData were analysed for patients (pts) who received ≥1 dose of tofacitinib 5 or 10 mg BID or placebo (PBO), integrated across 2 P3 studies (OPAL Broaden [12 months; NCT01877668]; OPAL Beyond [6 months; NCT01882439]) and 1 LTE study (OPAL Balance [ongoing, database not locked; NCT01976364]). Common adverse events (AEs; occurring in ≥2% of tofacitinib pts in any group) were analysed in the PBO-controlled portion (Months 0–3) of the P3 studies (Cohort 1 [C1]). Serious AEs (SAEs) and discontinuations due to AEs were analysed over 12 months in pts randomised to tofacitinib 5 or 10 mg BID in P3 studies (Cohort 2a [C2a]); pts randomised to PBO were excluded from this analysis. Deaths and AEs of special interest (serious infections [SI], herpes zoster [HZ], opportunistic infections [OI] including HZ, major adverse cardiac events [MACE], malignancies, non-melanoma skin cancer [NMSC]) were evaluated in all tofacitinib-treated pts in the P3 and LTE studies (Cohort 3 [C3]). Incidence rates (IR; pts with events/100 pt-years [PY] and 95% confidence intervals) are reported. Laboratory results will be reported in future publications.ResultsC1 included 474 tofacitinib- and 236 PBO-treated pts; C2a included 474 tofacitinib-treated pts; and C3 included 783 tofacitinib-treated pts (exposure: 776 PY). Nasopharyngitis (5.9%) and headache (8.5%) were the most commonly reported AEs at Month 3 in pts receiving tofacitinib 5 and 10 mg BID, respectively (Table). In pts randomised to tofacitinib 5 or 10 mg BID, over 12 months (C2a), the IRs for SAEs were 7.92 (4.09, 13.84) and 8.11 (4.19, 14.17), respectively. Discontinuation due to AEs occurred in 11 (4.6%) and 11 (4.7%) pts randomised to tofacitinib 5 and 10 mg BID, respectively, with IRs of 7.16 (3.58, 12.82) and 7.31 (3.65, 13.08), respectively, over 12 months (C2a). Across all tofacitinib-treated pts in the P3 and LTE studies (C3), SIs occurred in 11 pts (1.4%; IR 1.40 [0.70, 2.50]). HZ was reported in 16 pts (2.0%; IR 2.05 [1.17, 3.33]) receiving tofacitinib. All 3 cases of multidermatomal HZ were adjudicated as OIs; these were the only OIs (0.4%; IR 0.38 [0.08, 1.11]). In C3, 2 deaths occurred (0.3%; IR 0.25 [0.03, 0.91]); all were considered unrelated to the study drug. MACE were reported in 3 pts (0.4%; IR 0.38 [0.08, 1.11]), malignancies (excluding NMSC) in 5 pts (0.6%; IR 0.63 [0.21, 1.48]) and NMSC in 4 pts (0.5%; IR 0.51 [0.14, 1.30]).ConclusionsTofacitinib was well tolerated in pts with PsA, with a safety profile consistent to that seen in RA; no new risks were identified. Longer-term follow-up and larger pt populations will provide further information on the safety profile of tofacitinib in pts with PsA.AcknowledgementsThese studies were sponsored by Pfizer Inc. Editorial support was provided by C Viegelmann of CMC and was funded by Pfizer Inc.Disc...

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...

INTRODUCTION.Prevention measures are highly important to poor communities because surveillance and access to health care may be limited.OBJECTIVES We aimed establish measures to contain and suppress the spread of COVID-19, associating education, active case tracking, and humanitarian aid in two needy communities in Brazil. The adherence to the measures and evolution of the number of cases were verified during the project.MATERIALS AND METHODS.The target population consisted of approximately 1300 participants(350 families). A collection of epidemiological data was performed in family members registered for the project. Rapid tests were performed on people who had symptoms and their contacts. Scientific information through audio-visual materials,educational pamphlets written in colloquial language, food parcels,masks,hygiene and cleaning materials were provided directly to family nuclei. RESULTS The common needs faced by families were food inputs and/or ready-to-eat food, mentioned by 91.4% (233) of the people, and hygienic and cleaning materials, mentioned by 30.6% (78) of the people. Only 34.9% (84) of families had 70% rubbing alcohol or hand sanitizer gel at home.The most frequently cited sources of information on COVID-19 were television [cited by 82.4% (210) of the people]; social media [25.5% (65)]; friends, neighbours, or family members [13.7% (35)]; and radio [11.4% (29)] .A total of 83.7% (175) stated that the actions helped them to avoid leaving the community.CONCLUSIONS Community isolation may be the best way to contain the spread of pandemics in fragile populations with low socio-economic status.Educational actions combined with rapid testing and humanitarian aid were objective forms to promote community isolation.

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Background:Previous studies suggested that male sex may be associated with a greater rate of decline in FVC in patients with SSc-ILD. In the SENSCIS trial, nintedanib reduced the rate of FVC decline over 52 weeks vs placebo.Objectives:Analyse the rate of decline in FVC and the efficacy and safety of nintedanib in the SENSCIS trial in subgroups by sex.Methods:Patients with SSc-ILD with first non-Raynaud symptom <7 years before screening and ≥10% fibrosis of the lungs on HRCT were randomised to nintedanib or placebo. We analysed the rate of decline in FVC (mL/year) and adverse events over 52 weeks in male and female patients.Results:Of 576 patients, 433 (75.2%) were female. Compared with males, the female subgroup included a smaller proportion of White patients (64.7% vs 74.8%), a smaller proportion on mycophenolate at baseline (46.9% vs 53.1%), a greater proportion of ATA positive patients (63.3% vs 53.1%), and had a lower mean weight at baseline (66.6 vs 79.1 kg). FVC % predicted (72.8% vs 71.7%) and mRSS (11.2 vs 10.8) were similar in females and males. The adjusted annual rate of decline in FVC in the placebo group was numerically greater in male than female patients (-126.8 [SE 29.0] vs -82.0 [16.2] mL/year). The estimated effect of nintedanib vs placebo on reducing the rate of decline in FVC was numerically more pronounced in males than females (difference: 58.6 [95% CI -18.0, 135.1] vs 34.6 [-9.3, 78.4] mL/year), but the interaction p-value did not indicate heterogeneity in the treatment effect between subgroups (p=0.59). Among nintedanib-treated patients, diarrhoea was reported in similar proportions of females and males (74.7% vs 79.1%); nausea, vomiting and liver test abnormalities were reported in greater proportions of females vs males (35.3% vs 19.4%, 28.1% vs 13.4%, and 15.4% vs 9.0%), while serious adverse events were more frequent in males (32.8% vs 21.3%). In the nintedanib and placebo groups, respectively, adverse events leading to treatment discontinuation were reported in 16.7% and 8.5% of females and 13.4% and 9.2% of males.Conclusion:In the SENSCIS trial in patients with SSc-ILD, the annual rate of decline in FVC in the placebo group was numerically greater in male than female patients. The rate of FVC decline was lower with nintedanib than placebo both in males and females. The safety profile of nintedanib was similar between males and females.Disclosure of Interests:Elizabeth Volkmann Grant/research support from: Forbius, Corbus Pharmaceuticals, Consultant of: Boehringer Ingelheim, Forbius, Speakers bureau: Boehringer Ingelheim, Serena Vettori Consultant of: Boehringer Ingelheim, John Varga Grant/research support from: John Varga is awaiting grants from Boehringer Ingelheim and has received grants from Bristol-Myers Squibb, Pfizer, Takeda, and TeneoBio, Consultant of: John Varga has acted as a consultant for Boehringer Ingelheim, Bristol-Myers Squibb, Emerald Health, and TeneoBio, Ariane Herrick: None declared, Maurizio Cutolo Grant/research support from: Bristol-Myers Squibb, Actelion, Celgene, Consultant of: Bristol-Myers Squibb, Speakers bureau: Sigma-Alpha, Ana Cordeiro Consultant of: Ana Cordeiro has acted as a consultant for Roche, Speakers bureau: Ana Cordeiro has received speaker fees from Boehringer Ingelheim, Lilly, and Vitoria, Valderilio F Azevedo Grant/research support from: Abbvie, Janssen, Bristol-Myers Squibb, Boehringer-Ingelheim, Lilly and Novartis, Consultant of: Lilly, Novartis, Janssen, Boehringer-Ingelheim, Amgen, Pfizer and Abbvie, Speakers bureau: Sandoz, Celltrion, Lilly, Novartis, Janssen, Boehringer-Ingelheim, Amgen, Pfizer and Abbvie, Sindhu Johnson Grant/research support from: Boehringer Ingelheim, Corbus Pharmaceuticals, GlaxoSmithKline, Roche, Merck, Bayer, Consultant of: Boehringer Ingelheim, Ikaria, Christian Stock Employee of: Employee of Boehringer Ingelheim, Martina Gahlemann Employee of: Employee of Boehringer Ingelheim, Lizette Moros Employee of: Lizette Moros is an employee of Boehringer Ingelheim, Margarida Alves Employee of: Employee of Boehringer Ingelheim, Maureen Mayes Grant/research support from: Maureen Mayes has received grants from Boehringer Ingelheim, Corbus, CSL Behring, Eicos, and Galapagos, Consultant of: Maureen Mayes has acted as a consultant for Boehringer Ingelheim, Eicos, and Galapagos. She was a member of the SENSCIS trial Steering Committee (Boehringer Ingelheim)

BackgroundTofacitinib is an oral Janus kinase inhibitor for the treatment of psoriatic arthritis (PsA). The efficacy of tofacitinib has been evaluated in 2 Phase 3 studies in patients (pts) with PsA.ObjectivesTo describe the efficacy of tofacitinib by background methotrexate (MTX) dose in pts with PsA.MethodsThis post-hoc analysis utilised efficacy data pooled from 2 Phase 3, randomised, double-blind, placebo-controlled studies (OPAL Broaden [12 months; NCT01877668] and OPAL Beyond [6 months; NCT01882439]) in pts with a diagnosis (≥6 months) of active PsA (≥3 swollen and ≥3 tender joints). Pts in OPAL Broaden were tumour necrosis factor inhibitor (TNFi)-naïve and had an inadequate response (IR) to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD). Pts in OPAL Beyond had an IR to ≥1 TNFi. Pts were randomised to tofacitinib 5 or 10 mg twice daily (BID), placebo or adalimumab 40 mg subcutaneous every 2 weeks (OPAL Broaden; adalimumab data not shown). All pts received a stable dose of 1 csDMARD (eg MTX, leflunomide or sulfasalazine) as background therapy. The maximum dose of MTX allowed per protocol was 20 mg/week. Efficacy outcomes for tofacitinib at Month 3 were evaluated by background MTX dose (≤15 vs>15 mg/week) and included: ACR20/50/70 response rates (≥20/50/70% improvement from baseline, respectively), Health Assessment Questionnaire-Disability Index (HAQ-DI) response rate (reduction from baseline ≥0.35 points) and mean change from baseline in HAQ-DI score. Analyses were based on the full analysis set for pts receiving MTX on Day 1; pts with missing data were considered as having a non-response for binary endpoints. No statistical testing was performed.ResultsIn total, data from 556 pts who received tofacitinib plus MTX only or placebo plus MTX only (tofacitinib 5 mg BID, n=186; tofacitinib 10 mg BID, n=178; placebo, n=192) were included in this analysis. Most pts were treated with background MTX at doses≤15 mg/week (n=371, 66.7%; mean [SD] dose, 12.6 [3.1] mg/week) vs >15 mg/week (n=185, 33.3%; mean [SD] dose, 19.8 [0.8] mg/week). Baseline demographics and disease characteristics were generally similar between arms in MTX dose groups (table 1). At Month 3, tofacitinib 5 and 10 mg BID were generally associated with numerically greater ACR and HAQ-DI response rates and greater changes from baseline in HAQ-DI score compared with placebo. The magnitude of tofacitinib effects on efficacy outcomes appeared broadly similar between background MTX dose groups (table 1).Abstract AB0902 – Table 1Patient demographics and disease characteristics at baseline, and efficacy outcomes at Month 3 by MTX dose*Among pts with baseline HAQ-DI score ≥0.35Missing values for ACR20/50/70 response rates and HAQ-DI response rate were considered as non-response to treatmentLSM were calculated based on a mixed model for repeated measures without imputation for missing valuesThe maximum permitted dose of MTX was 20 mg/weekThe analyses included all pts who received MTX as background therapy only on Day 1 in the FASACR, ...