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This study characterized real-world demographic and baseline clinical characteristics, as well as treatment persistence and adherence, in patients with psoriatic arthritis (PsA) who had newly initiated tofacitinib treatment.This retrospective cohort study included patients aged 18 years or older in the IBM MarketScan™ US database with at least one tofacitinib claim (first = index) between December 14, 2017 and April 30, 2019; PsA diagnoses on/within 12 months pre-index; and no diagnoses of rheumatoid arthritis any time pre-index. Patients were continuously enrolled for 12 months pre-index and 6 months post-index, with no pre-index claims for tofacitinib. Patient demographic and clinical characteristics on the day of index, and history of advanced treatments (including tofacitinib monotherapy or combination therapy), were recorded. Outcomes at 6 months post-index included tofacitinib persistence (less than 60-day gap without tofacitinib treatment) and adherence (proportion of days covered [PDC] and medication possession ratio 80% or higher).Of the 10,354 patients with tofacitinib claims within the study period, 318 patients with PsA met the inclusion criteria. More than 60% of patients received tofacitinib monotherapy post-index, with a mean duration of PsA of 760.5 days at index. For patients who received tofacitinib combination therapy post-index, methotrexate was the most common concomitant conventional synthetic disease-modifying antirheumatic drug. At 6 months post-index, persistence was similar in patients receiving tofacitinib monotherapy (69.8%) versus combination therapy (73.1%); adherence (as measured by PDC ≥ 0.8) was numerically lower in patients receiving tofacitinib monotherapy (56.8%) versus combination therapy (65.5%).This analysis of US-based claims data described patients who had newly initiated tofacitinib treatment an average of 2 years after PsA diagnosis, with approximately two-thirds of patients receiving tofacitinib monotherapy. Observed rates of tofacitinib persistence were similar across patients who received tofacitinib monotherapy and combination therapy 6 months after initiation; adherence rates were numerically lower in patients receiving monotherapy.Tofacitinib is a drug approved to treat patients with psoriatic arthritis (PsA) that has been shown to improve PsA symptoms and quality of life in controlled clinical trials. However, there is not much information on everyday use of tofacitinib outside of clinical trials in the USA. This study is one of the first to describe the characteristics of patients with PsA in the USA who take tofacitinib, including their typical age, sex, where they live, how long they have had PsA, and how they use tofacitinib. Use of tofacitinib included how patients followed tofacitinib prescription timings and dose (adherence) and how long they took tofacitinib for after it was prescribed (persistence). We used data collected from a US health insurance claims database (IBM MarketScan™) for patients with PsA and at least one claim for tofacitinib. In total, 318 patients were included and over 60% of them received tofacitinib therapy only (monotherapy; no conventional synthetic disease-modifying antirheumatic drug [csDMARD] therapy). For patients treated with both tofacitinib and a csDMARD (combination therapy), methotrexate was the most common drug prescribed. Six months after their first prescription of tofacitinib, around 70% of patients were still taking tofacitinib (monotherapy or combination therapy). However, a slightly lower number of patients taking tofacitinib monotherapy were taking it as originally instructed (adherence 57%), compared with those taking tofacitinib combination therapy (adherence 66%). Our results provide valuable information on the use of tofacitinib in US real-life settings outside of clinical trials and could help to improve the quality of care for patients with PsA.

Comparative data on the economic burden of alopecia areata relative to the general population are limited. The objective of this retrospective database analysis was to evaluate healthcare resource utilization and direct medical costs among patients with alopecia areata from the US payer perspective compared with matched controls.Validated billing codes were used to identify patients with alopecia areata from the IQVIA PharMetrics Plus (2016-2018) who had continuous pharmacy and medical enrollment for 365 days both before (baseline period) and after (evaluation period) the index date. Demographic and clinical characteristics were characterized, and baseline comorbidities were assessed with the Quan Charlson Comorbidity Index.Using the exact matching feature from Instant Health Data, 14,340 patients with alopecia areata were matched with 42,998 control patients aged ≥ 12 years. Patients with alopecia areata had higher healthcare resource utilization and adjusted total all-cause mean medical costs versus matched controls ($8557 versus $6416; p 0.0001), because of higher inpatient costs, emergency department visits, ambulatory visits, number of prescriptions and prescription costs, and other costs such as durable medical equipment and home healthcare. The number of inpatient visits did not significantly differ between the two groups. Mean ambulatory costs were $3640 for patients with alopecia areata and $2062 for controls, and mean pharmacy costs were $3287 and $1843, respectively (p 0.0001 for both). Pharmacy costs related to immunologic agents represented 50.0% of the total difference in pharmacy spending between patients with alopecia areata and controls. Surgery on the integumentary system accounted for 9.5% of the total difference in ambulatory costs.Alopecia areata is associated with significant incremental healthcare resource utilization and costs relative to matched controls due to increased spending in areas such as surgical procedures and psychological and pharmacological interventions. Costs are primarily driven by ambulatory and pharmacy spending.

Atopic dermatitis (AD) is a chronic and relapsing inflammatory skin disease that negatively impacts overall health, quality of life (QoL), and work productivity. Prior studies on AD burden by severity have focused on moderate-to-severe disease. Here, we describe the clinical and humanistic burden of AD in Europe across all severity levels, including milder disease.Data were analyzed from the 2017 National Health and Wellness Survey from adult respondents with AD in the EU-5 (France, Germany, Italy, Spain, and the UK). AD disease severity was defined based on self-reported assessments as "mild," "moderate," or "severe" and by Dermatology Life Quality Index (DLQI) severity bands. Self-reported outcomes for AD respondents by severity were assessed using propensity score matching. These outcomes included a wide range of selected medical/psychological comorbidities, overall QoL and functional status (EuroQol 5-Dimensions 5-Level and Short Form-36 version 2 questionnaires), and work productivity and activity impairment (Work Productivity and Activity Impairment questionnaire).In total, 4208 respondents with AD (mild AD, 2862; moderate AD, 1177; severe AD, 169) and 4208 respondents without AD were included in this analysis. Results showed greater burden across severity levels compared with matched non-AD controls. A higher proportion of respondents with mild-to-moderate AD, defined by DLQI severity bands, reported atopic comorbidities (P 0.05) and a wide range of cardiac, vascular, and metabolic comorbidities, including hypertension, high cholesterol, angina, and peripheral vascular disease (P 0.005), compared with non-AD controls. Relative to potential impacts of various medical and psychological burdens, respondents with mild-to-moderate AD reported higher activity impairment than controls (P 0.0001).Clinical and humanistic burden was observed in European respondents with AD compared with matched non-AD controls across severity levels, with burden evident even in milder disease, highlighting the importance of improving disease management in early stages of AD.

Introduction The burden of mild-to-moderate atopic dermatitis (AD) in the United Kingdom (UK) is not well understood. Long-lasting AD flares may lead to systemic inflammation resulting in reversible progression from mild to more severe AD. This study aimed to assess the clinical and economic burden of mild-to-moderate AD in the UK. Methods AD patients were identified in the Health Improvement Network (THIN) from 2013 to 2017 and propensity score matched to non-AD controls by demographics. Patients were identified based on continuous disease activity using validated algorithms and sufficient patient status to fully validate data integrity for the entire period. Mild-to-moderate AD patients were identified by using treatment as a surrogate. Demographics, clinical characteristics and healthcare resource use (HCRU) were obtained from THIN. Literature reviews were conducted to obtain additional outcomes. A cost-of-illness model was developed to extrapolate the burden in 2017 to the UK population and in subsequent years (2018–2022). Results In 2017, the prevalence of mild-to-moderate AD in THIN was 1.28%. These patients reported higher comorbidity rates and significantly higher (p

The Canadian Tofacitinib for Rheumatoid Arthritis Observational (CANTORAL) is the first Canadian prospective, observational study assessing tofacitinib. The objective was to assess effectiveness and safety for moderate to severe rheumatoid arthritis (RA). Coprimary and secondary outcomes are reported from an interim analysis.Patients initiating tofacitinib from October 2017 to July 2020 were enrolled from 45 Canadian sites. Coprimary outcomes (month 6) included the Clinical Disease Activity Index (CDAI)-defined low disease activity (LDA) and remission. Secondary outcomes (to month 18) included the CDAI and the 4-variable Disease Activity Score in 28 joints (DAS28) using the erythrocyte sedimentation rate (ESR)/C-reactive protein (CRP) level to define LDA and remission; the proportions of patients achieving mild pain (visual analog scale20 mm), and moderate (≥30%) and substantial (≥50%) pain improvements; and the proportions of patients achieving a Health Assessment Questionnaire disability index (HAQ DI) score greater or equal to normative values (≤0.25) and a HAQ DI score greater or equal to minimum clinically important difference (MCID) (≥0.22). Safety was assessed to month 36.Of 504 patients initiating tofacitinib, 44.4% received concomitant methotrexate. At month 6, 52.9% and 15.4% of patients were in CDAI-defined LDA and remission, respectively; a similar proportion of patients achieved outcomes by month 3 (first post-baseline assessment). By month 3, 27.2% and 41.7% of patients, respectively, were in DAS28-ESR-defined LDA and DAS28-CRP3.2; 14.7% and 25.8% achieved DAS28-ESR remission and DAS28-CRP2.6. By month 3, mild pain and moderate and substantial pain improvements occurred in 29.6%, 55.6%, and 42.9% of patients, respectively; 19.9% and 53.7% of patients achieved a HAQ DI score greater than or equal to normative values and a HAQ DI score greater than or equal to MCID, respectively. Outcomes were generally maintained to month 18. Incidence rates (events per 100 patient-years) for treatment-emergent adverse events (AEs), serious AEs, and discontinuations due to AEs were 126.8, 11.9, and 14.5, respectively, and AEs of special interest were infrequent.Tofacitinib was associated with early and sustained improvement in RA signs and symptoms in real-world patients. Effectiveness and safety were consistent with the established tofacitinib clinical profile.

Introduction Atopic dermatitis (AD) is associated with sleep difficulties, depression, and anxiety. We evaluated the relationship between these psychosocial comorbidities and health outcomes among adults with moderate-to-severe AD in the USA. Methods Data were analyzed from the 2017 US National Health and Wellness Survey. Respondents with a physician diagnosis of AD or eczema with moderate-to-severe AD based on a Dermatology Life Quality Index score of 6 or more were included. Generalized linear models were used to examine the relationship between psychosocial comorbidities (sleep difficulties and anxiety based on self-report, depression based on the Patient Health Questionnaire-9) and health outcomes [the 36-item Short Form Health Survey, version 2; EuroQol five-dimension, five-level; Work Productivity and Activity Impairment questionnaire; and healthcare resource utilization (HRU)]. Results Among respondents with moderate-to-severe AD (N = 1017), 56.6%, 70.7%, and 60.9% reported sleep difficulties, depression, and anxiety, respectively. These comorbidities were significantly associated with reduced physical and mental component summary scores and increased overall work impairment (P

BackgroundEvaluate the impact of sex on tofacitinib efficacy, safety and persistence (time to discontinuation) in patients with psoriatic arthritis (PsA).MethodsData were pooled from two phase 3 randomised controlled trials. Patients were randomised to tofacitinib 5 mg or 10 mg two times per day, adalimumab 40 mg every 2 weeks or placebo. Efficacy outcomes to month 12 included American College of Rheumatology (ACR)20/50/70, minimal disease activity (MDA), Psoriasis Area Severity Index (PASI)75, change from baseline (∆) in Health Assessment Questionnaire-Disability Index (HAQ-DI) and ∆Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). Safety was assessed to month 12 and persistence was assessed to month 42 of a long-term extension study.ResultsOverall, 816 patients were included (54.3% females). At baseline, higher tender joint counts, enthesitis scores and worse HAQ-DI and FACIT-F were reported in females versus males; presence of dactylitis and PASI were greater in males versus females. At month 3, tofacitinib efficacy generally exceeded placebo in both sexes. Overall, similar ACR20/50/70, PASI75, ∆HAQ-DI and ∆FACIT-F were observed for tofacitinib between sexes; females were less likely to achieve MDA. Similar proportions of males/females receiving tofacitinib (both doses) experienced treatment-emergent adverse events (AEs). Serious AEs occurred in 3.4%/6.6% and 4.0%/5.9% males/females with tofacitinib 5 mg and 10 mg two times per day. Persistence was generally similar between sexes.ConclusionTofacitinib efficacy exceeded placebo in both sexes and was comparable between sexes. Consistent with previous studies of PsA treatments, females were less likely to achieve MDA, likely due to baseline differences. Safety and time to discontinuation were generally similar between sexes.Trial registration numberNCT01877668;NCT01882439;NCT01976364.

Introduction Atopic dermatitis (AD) is a common inflammatory disease of the skin, which may have a substantial impact on patients' health-related quality of life (HRQoL). The aim of this study was to quantify the economic burden (direct and indirect costs) of moderate-to-severe AD and evaluate the prevalence and impact of psychosocial comorbidities among patients in the European Union-5 (France, Germany, Italy, Spain, and the UK). Methods Data were analyzed from the 2017 EU5 National Health and Wellness Survey. Respondents with a physician diagnosis of AD/eczema who were considered to have moderate-to-severe AD based on a Dermatology Life Quality Index (DLQI) score ≥ 6 were included. Direct costs, indirect costs, and psychosocial comorbidities (sleep difficulties and anxiety based on self-report, depression based on the Patient Health Questionnaire-9) were reported descriptively. Generalized linear models were used to examine the relationship between psychosocial comorbidities and health outcomes (the Short Form-36 version 2 [SF-36v2], EuroQoL 5-dimension 5-level, Work Productivity and Activity Impairment questionnaire, and healthcare resource utilization). Results Overall, 1014 patients were included in the analysis. Total annual direct costs ranged from €2242 to €6924 and total annual indirect costs ranged from €7277 to €14,236, depending on the level of disease severity. Sleep difficulties, anxiety, and depression were reported by 61.6%, 52.7%, and 75.8% of patients, respectively. These comorbidities were significantly associated with reduced physical and mental component summary scores from SF-36v2 and increased overall work impairment (p

Introduction Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). To provide additional clinical evidence in regulatory submissions for a modified-release (MR) once-daily (QD) tofacitinib formulation, we compared real-world adherence and effectiveness between patients initiating the MR QD formulation and patients initiating an immediate-release (IR) twice-daily (BID) formulation. Methods Two noninterventional cohort studies were conducted. First, adherence and two effectiveness proxies were compared between patients with RA who newly initiated tofacitinib MR 11 mg QD or IR 5 mg BID in the IBM® MarketScan® Commercial and Medicare Supplemental US insurance claims databases (March 2016–October 2018). Second, using data collected in the Corrona US RA Registry (February 2016–August 2019), two Clinical Disease Activity Index (CDAI)-based measures of effectiveness were compared between tofacitinib MR 11 mg QD and IR 5 mg BID, and against noninferiority criteria derived from placebo-controlled clinical trials of the tofacitinib IR formulation. Multiple sensitivity analyses of the registry data were conducted to reassure regulators of consistent results across different assumptions. Results In each study, approximately two-thirds of patients initiated the MR formulation. In the claims database study, improved adherence and at least comparable effectiveness were observed with tofacitinib MR vs IR over 12 months, particularly in patients without prior advanced therapy. In the registry study, the noninferiority of tofacitinib MR vs IR was demonstrated for both CDAI outcomes at ~6 months; this finding was robust across multiple sensitivity analyses. Conclusion These results demonstrate the value of real-world evidence from complementary data sources in understanding the impact of medication adherence with a QD formulation in clinical practice. These analyses were suitable for regulatory consideration as an important component of evidence for the comparability of tofacitinib MR 11 mg QD vs IR 5 mg BID in patients with RA. Trial Registration Claims database study: ClinicalTrials.gov identifier NCT04018001, retrospectively registered July 12, 2019. Corrona US RA Registry study: ClinicalTrials.gov identifier NCT04267380, retrospectively registered February 12, 2020. Electronic supplementary material The online version of this article (10.1007/s12325-020-01501-z) contains supplementary material, which is available to authorized users.

Many patients with atopic dermatitis (AD) have a suboptimal response to systemic therapy.This study assessed predictors of nonresponse to dupilumab in patients with AD.Data (April 2017 through June 2019) for patients aged 12 years and above with AD (International Classification of Diseases-9/10-Clinical Modification: 691.8/L20.x) who initiated dupilumab on or after April 1, 2017 (index date) were collected from an electronic health record and insurance claims database. Nonresponse indicators (dupilumab discontinuation, addition of another systemic therapy or phototherapy, addition of a high-potency topical corticosteroid, AD-related hospital visit, AD-related emergency department visit, incident skin infection) were predicted from available demographic and clinical variables using machine learning.Among 419 patients (mean age: 45 years), 145 (35%) experienced at least 1 indicator of nonresponse in the 6-month postindex period. In patients with at least 1 indicator, the most common was dupilumab discontinuation (47% [68/145]). Of note, this analysis could not capture nonmedical reasons for dupilumab discontinuation (eg, cost, access). The most common predictors of nonresponse were a claim for ibuprofen (in 69% of patients with a nonresponse indicator) and a Quan-Charlson Comorbidity Index value of 3 to 4 (59%).Systemic dupilumab therapy for AD can be associated with a relatively high prevalence of nonresponse indicators. Factors associated with these indicators-that is, predictors of nonresponse-may be used to optimize disease management.

Objective: Tofacitinib is an oral JAK inhibitor for the treatment of rheumatoid arthritis (RA). To better understand tofacitinib treatment responses, we used group-based trajectory modeling to investigate distinct disease activity trajectories and associated baseline variables in patients with active RA. Methods: This post hoc analysis used data from a phase III study of methotrexate-naive patients receiving tofacitinib 5 mg twice daily. Changes in the 4-variable Disease Activity Score in 28 joints, using the erythrocyte sedimentation rate (DAS28-ESR) from baseline to month 24 were used in group-based trajectory modeling to identify distinct disease activity trajectories. Patient and disease characteristics, changes in radiographic progression and patient-reported outcomes, and safety up to month 24 were compared among trajectory groups. Results: From 346 methotrexate-naive patients, 5 disease trajectory groups, defined by DAS28-ESR scores, were identified, which progressed from high disease activity (HDA) to remission (group 1, n = 28), to low disease activity (LDA) rapidly (group 2, n = 107), to moderate disease activity (group 3, n = 98), to LDA gradually (group 4, n = 46), or remained in HDA (group 5, n = 67), at month 24. At baseline, groups 1 and 2 generally had lower disease activity and more favorable patient-reported outcomes, compared with other groups. Improvements in radiographic progression and patient-reported outcomes over 24 months were generally consistent with DAS28-ESR–predicted disease activity trajectories. Adverse event rates were generally comparable across groups. Conclusion: Distinct phenotypic subgroups identified heterogeneity in patients with RA normally analyzed as a single population. Trajectory modeling may enable separation of clinically meaningful subsets of patients with RA, and may help optimize treatment outcomes.

Introduction No published studies exist comparing the effectiveness of tofacitinib with other advanced therapies for the treatment of rheumatoid arthritis (RA) in real-world clinical practice. Here, we report differences in effectiveness of tofacitinib compared with standard of care, tumor necrosis factor inhibitors (TNFi), with or without concomitant methotrexate (MTX), using US Corrona registry data. Methods This observational cohort study included RA patients receiving tofacitinib (from 6 November 2012; N = 558) or TNFi (from 1 November 2001; N = 8014) with or without MTX until 31 July 2016. Efficacy outcomes at 6 months included modified American College of Rheumatology 20% responses, Clinical Disease Activity Index (CDAI) and Pain. Outcomes were compared between patients receiving TNFi and tofacitinib with or without MTX and by line of therapy. Outcomes within therapy lines were compared using propensity-score matching; between-group differences were estimated using mixed-effects regression models. Results Patients receiving tofacitinib had longer RA duration and a greater proportion had previously received biologics than those receiving TNFi; other baseline characteristics were comparable. In patients receiving second- and third-line TNFi therapy, CDAI low disease activity/remission response rates were significantly better with concomitant MTX. Too few patients received tofacitinib as second line for meaningful assessment. No significant differences were observed in outcomes between tofacitinib as monotherapy and tofacitinib with concomitant MTX. Conclusions In clinical practice, TNFi efficacy is improved with concomitant MTX in the second and third line. In the third/fourth line, patients are likely to achieve similar efficacy with tofacitinib monotherapy, or TNFi or tofacitinib in combination with MTX. Funding Pfizer Inc Electronic supplementary material The online version of this article (10.1007/s40744-019-00177-4) contains supplementary material, which is available to authorized users.

Using data from real-world practice, this analysis compared outcomes in patients with rheumatoid arthritis (RA) initiating treatment with an oral Janus kinase inhibitor, tofacitinib, in combination with persistent, discontinued, or interrupted treatment with oral methotrexate (MTX).This retrospective claims analysis (MarketScan® databases) included data from US patients with RA and at least one prescription claim for tofacitinib, dated between January 1, 2013, and April 30, 2017. Eligible patients were continuously enrolled for ≥12 months before and after treatment initiation, and initiated tofacitinib in combination with oral MTX, with at least two prescription claims for each. Patients were grouped according to treatment pattern (MTX-Persistent, MTX-Discontinued, or MTX-Interrupted). Tofacitinib treatment persistence, adherence, and effectiveness, as well as all-cause and RA-related health care costs, were assessed.A total of 671 patients were eligible for inclusion; 504 (75.1%) were MTX-Persistent; 131 (19.5%), MTX-Discontinued; and 36 (5.4%), MTX-Interrupted. Rates of tofacitinib treatment persistence, adherence, and effectiveness at 12 months were similar between the MTX-Persistent and MTX-Discontinued cohorts. The percentage of patients switched from tofacitinib to another advanced disease-modifying antirheumatic drug within 12 months of tofacitinib initiation was greater in the MTX-Persistent cohort compared with that in the MTX-Discontinued cohort. RA-related health care costs at 12 months post-initiation were significantly greater in the MTX-Persistent cohort compared with those in the MTX-Discontinued cohort.The findings from this analysis of real-world data indicate that patients who initiate tofacitinib in combination with oral MTX may discontinue MTX and still experience outcomes similar to those in patients who persist with MTX, with lesser RA-related health care costs. These results support those from a previous clinical study on methotrexate withdrawal in patients with RA (NCT02831855).

Background Fatigue, a common symptom of rheumatoid arthritis (RA), is detrimental to health-related quality of life (HRQoL). We evaluated the impact of tofacitinib on fatigue, sleep, and HRQoL and explored associations between fatigue, related patient-reported outcomes (PROs), and disease activity in RA patients. Methods This post hoc analysis pooled data from three Phase 3 studies of tofacitinib (ORAL Scan; ORAL Standard; ORAL Sync) in RA patients. Patients received tofacitinib 5 or 10 mg twice daily, placebo, or adalimumab (active control; ORAL Standard only, not powered for superiority) with conventional synthetic disease-modifying antirheumatic drugs. Assessed through Month (M)12 were changes from baseline in disease activity, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Medical Outcomes Study Sleep scale (MOS-SS), and Short Form-36 Health Survey (SF-36) composite/domain scores, and proportions of patients reporting improvements from baseline in FACIT-F total and SF-36 domain scores ≥ minimum clinically important differences (MCIDs) or ≥ population normative values. Pearson correlations examined associations among PROs at M6. Treatment comparisons were exploratory, with p < 0.05 considered nominally significant. Results Generally, active treatment led to significant improvements from baseline in FACIT-F total, and MOS-SS and SF-36 composite/domain scores vs placebo, observed by M1 and maintained through M6 (last placebo-controlled time point). Through M6, more patients achieved improvements from baseline ≥ MCID and achieved scores ≥ population normative values in FACIT-F total and SF-36 domain scores with tofacitinib vs placebo. Through M12, some nominally significant improvements with tofacitinib vs adalimumab were observed. With active treatment at M6, FACIT-F scores were moderately (0.40–0.59) to highly (≥ 0.60) correlated with SF-36 composite/domain scores (particularly vitality), moderately correlated with most MOS-SS domain scores, and highly correlated with MOS-SS Sleep Problems Index I scores. Disease activity correlations were moderate with FACIT-F scores and low (0.20–0.39) to moderate with SF-36 general health domain/composite scores. Conclusion Tofacitinib and adalimumab generally conferred significant, clinically meaningful improvements in fatigue, sleep, and HRQoL (including vitality) vs placebo through M6, with improvements maintained to M12. M6 correlations between FACIT-F, PROs of sleep, HRQoL, and disease activity underscore the interrelatedness of multiple PROs and disease activity in RA. Trial registration ClinicalTrials.govNCT00847613 (registered: February 19, 2009); NCT00853385 (registered: March 2, 2009); NCT00856544 (registered: March 5, 2009).

Background: Biologic therapies are often used in patients with ulcerative colitis (UC) who are nonresponsive to conventional treatments. However, nonresponse or loss of response to biologics often occurs, leading to dose escalation, combination therapy, and/or treatment switching. We investigated real-world treatment patterns of biologic therapies among patients with UC in the USA. Methods: This study analyzed data from the IBM® MarketScan® Commercial and Medicare Supplemental Databases (medical/pharmacy claims for >250 million patients in the USA) to identify patients with UC initiating a biologic therapy (adalimumab, infliximab, golimumab, or vedolizumab) with 12 months of follow-up post-initiation. Key measures were patient baseline characteristics, dose escalation (average maintenance dose >20% higher than label), adherence (proportion of days covered), and ulcerative colitis-related healthcare costs in the 12 months following biologic therapy initiation. Results: Of 2,331 patients included in the study (adalimumab [N = 1,291], infliximab [N = 810], golimumab [N = 127], and vedolizumab [N = 103]), 28.1% used concomitant immunosuppressant therapy within 12 months post-initiation. Overall, 23.6% (adalimumab), 34.8% (infliximab), 9.9% (golimumab), and 39.2% (vedolizumab) of patients dose escalated within 12 months. Patients who dose escalated incurred USD 20,106 higher total UC-related healthcare costs over 12 months than those who did not. Adherence (covariate-adjusted proportion of days covered) ranged from 0.63 to 0.73, and 39.3% of patients discontinued within 12 months (median treatment duration = 112 days). Conclusion: Dose escalation was common, and incurred higher costs, in patients with UC initiating biologic therapies. Suboptimal adherence and/or discontinuation within 12 months of initiation occurred frequently, highlighting the challenges in managing these patients.

In this real-world analysis, patients with ulcerative colitis frequently required steroids up to a year after initiating immunosuppressant or biologic therapies, with high ulcerative colitis-related costs. This suggests an ongoing challenge in managing patients with moderate to severe ulcerative colitis., Background Ulcerative colitis (UC) treatment aims to induce response and maintain steroid-free remission. For patients with moderate to severe UC and/or nonresponse to conventional treatment, advanced therapies (immunosuppressants and biologics) are available. We assessed real-world effectiveness of advanced UC therapies. Methods This retrospective analysis of claims data included adult patients with UC initiating immunosuppressant or biologic therapy, with 12 months’ continuous enrollment pre- and postinitiation. Patients had no prescription for biologic therapy (and/or immunosuppressant if initiating immunosuppressant) in the previous 12 months. Proportion of patients remaining steroid-free (excluding 14-week tapering period), hospitalizations, and costs in the 12 months postinitiation were assessed. Results In total, 3562 patients were included in the analysis. Most patients (83.0%) used steroids in the 12 months before initiating advanced therapy. Overall, 47.8% remained steroid-free after 12 months (excluding tapering). After adjusting for patient characteristics, remaining steroid-free was significantly more likely with infliximab (43.9%) than with adalimumab (39.4%; P < 0.05); golimumab (38.2%) and vedolizumab (41.4%) were not significantly different vs adalimumab. Overall, 12.2% of patients had a UC-related hospitalization within 12 months of initiation, with a mean (SD) total length of stay of 8.2 (8.9) days and no significant differences between biologic therapies. Mean, unadjusted, UC-related costs in the 12 months postinitiation were $42,579 and were similar between therapies. Conclusions Patients with UC initiating advanced therapy frequently continued using steroids for at least a year. Some patients experienced extended UC-related hospitalizations, with high UC-related costs overall. This suggests an ongoing challenge in managing patients with moderate to severe UC.

The approval of new medicinal agents requires robust efficacy and safety clinical trial data demonstrated to be applicable to population subgroups. Limited data have previously been reported by drug sponsors on the topic of clinical trial diversity. In order to establish a baseline of diversity in our clinical trials that can be used by us and other sponsors, an analysis of clinical trial diversity was conducted covering race, ethnicity, sex, and age. This analysis includes Pfizer interventional clinical trials that initiated enrollment between 2011 through 2020. The data set comprises 213 trials with 103,103 US participants. The analysis demonstrated that overall trial participation of Black or African American individuals was at the US census level (14.3% vs 13.4%), participation of Hispanic or Latino individuals was below US census (15.9% vs 18.5%), and female participation was at US census (51.1% vs 50.8%). The analysis also examined the percentage of trials that achieved racial and ethnic distribution levels at or above census levels. Participant levels above census were achieved in 56.1% of Pfizer trials for Black or African American participants, 51.4% of trials for White participants, 16.0% of trials for Asian participants, 14.2% of trials for Native Hawaiian and Pacific Islander participants, 8.5% of trials for American Indian and Alaska Native participants, and 52.3% of trials for Hispanic or Latino participants. The results presented here provide a baseline upon which we can quantify the impact of our ongoing efforts to improve racial and ethnic diversity in clinical trials.

Background:Differences in efficacy outcomes favouring males vs females with rheumatoid arthritis (RA) have been reported with conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) and tumour necrosis factor inhibitors; results with Janus kinase inhibitors are less clear.Objectives:To assess the impact of sex on efficacy, safety and persistence in tofacitinib RA clinical trials.Methods:Efficacy and safety analyses included data pooled from Phase (P)3 randomised controlled trials (RCTs) of patients (pts) with RA and an inadequate response (IR) to methotrexate (NCT00847613; NCT00853385) or ≥1 DMARD (NCT00856544) who received tofacitinib 5 or 10 mg twice daily (BID), adalimumab (ADA) 40 mg Q2W or placebo (PBO), with background csDMARDs. Persistence analyses of pts receiving tofacitinib 5 or 10 mg BID ± csDMARDs used data pooled from two long-term extension trials (NCT00661661; NCT00413699). Efficacy outcomes to Month (M)12 included: ACR20/50/70 responses, changes from baseline (Δ; BL) in DAS28-4(ESR), CDAI, HAQ-DI and FACIT-F, and DAS28-4(ESR) remission (Results:2265 pts were included from P3 RCTs. Demographics and BL characteristics were comparable across sexes and treatments. Tofacitinib or ADA vs PBO generally led to significantly higher ACR20/50/70 responses in both sexes through M6. To M12, ACR20/50/70 responses were broadly comparable across active treatments and between sexes, with significant differences favouring males at some time points, including M3 (Figure 1). Statistically significant differences favouring males vs females were observed in DAS28-4(ESR) remission rates at most time points, including M3 (Figure 1); a similar trend was observed for ΔDAS28-4(ESR). ΔCDAI, ΔHAQ-DI and ΔFACIT-F significantly favoured males vs females receiving tofacitinib 5 mg BID at most time points, while ΔHAQ-DI and ΔFACIT-F tended to favour females receiving tofacitinib 10 mg BID. Rates of adverse events (AEs), serious AEs (SAEs), severe AEs and discontinuations due to AEs were slightly higher in females vs males with tofacitinib 5 mg BID; this was generally reversed with tofacitinib 10 mg BID and ADA (Table 1). AEs of special interest (AESI) were comparable between sexes with tofacitinib and ADA, although low event numbers limit interpretation (Table 1). Time to all-cause discontinuation and discontinuation due to AEs/lack of efficacy with tofacitinib 5 mg BID was similar between sexes. Numerical differences favouring females vs males were observed for time to all-cause discontinuation and discontinuation due to AEs with tofacitinib 10 mg BID.Table 1.Safety summary to M24 in pooled DMARD-IR P3 RCTsTofacitinib5 mg BIDTofacitinib10 mg BIDADAPts with events,n (%)Females(N=707)Males(N=133)Females(N=698)Males(N=137)Females(N=162)Males(N=42)AEs562 (79.5)85 (63.9)529 (75.8)107 (78.1)119 (73.5)30 (71.4)SAEs107 (15.1)17 (12.8)71 (10.2)24 (17.5)13 (8.0)6 (14.3)Severe AEs86 (12.2)12 (9.0)55 (7.9)22 (16.1)14 (8.6)5 (11.9)Discontinuations due to AEs87 (12.3)10 (7.5)88 (12.6)10 (7.3)17 (10.5)5 (11.9)Death6 (0.8)4 (3.0)03 (2.2)1 (0.6)2 (4.8)AESISerious infections28 (4.0)6 (4.5)27 (3.9)6 (4.4)2 (1.2)1 (2.4)All HZ (non-serious/serious)35 (5.0)7 (5.3)43 (6.2)5 (3.6)2 (1.2)3 (7.1)MACE5 (0.7)02 (0.3)3 (2.2)03 (7.1)Malignancies (excl. NMSC)7 (1.0)1 (0.8)9 (1.3)1 (0.7)01(2.4)NMSC2 (0.3)5 (3.8)4 (0.6)2 (1.5)1 (0.6)1 (2.4)Venous thromboembolism3 (0.4)03 (0.4)1 (0.7)00HZ, herpes zoster; MACE, major adverse cardiovascular events; NMSC, non-melanoma skin cancerConclusion:Efficacy outcomes with tofacitinib and ADA were generally higher in males and comparable in females vs previously reported mixed population response rates for advanced therapies. Safety findings did not reveal a consistent pattern between sexes. Tofacitinib persistence was similar between sexes.Acknowledgements:Study sponsored by Pfizer Inc. Medical writing support was provided by Christina Viegelmann, CMC Connect, and funded by Pfizer Inc.Disclosure of Interests:H Niall Jones Consultant of: Pfizer Inc, Vibeke Strand Consultant of: AbbVie, Amgen, Arena, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion, Corrona, Eli Lilly, Galapagos, Genentech/Roche, Gilead, GlaxoSmithKline, Ichnos, Inmedix, Janssen, Kiniksa, Merck, Myriad Genetics, Novartis, Pfizer Inc, Regeneron, Samsung, Sandoz, Sanofi, Scipher, SetPoint Medical, UCB, Hendrik Schulze-Koops Consultant of: AbbVie, Amgen, Biogen, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead Sciences, Hexal Sandoz, Hospira, Janssen-Cilag, MSD, Novartis, Pfizer Inc, Roche, UCB, Grant/research support from: Novartis, Pfizer Inc, Eduardo Mysler Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Pfizer Inc, Roche, Sanofi, Grant/research support from: Eli Lilly, Pfizer Inc, Roche, Cassandra Kinch Shareholder of: Pfizer Canada ULC, Employee of: Pfizer Canada ULC, David C Gruben Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Rebecca Germino Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Carol A. Connell Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Lihi Eder Speakers bureau: AbbVie, UCB, Consultant of: AbbVie, Celgene, Eli Lilly, Novartis, Pfizer Inc, UCB, Grant/research support from: AbbVie, Eli Lilly, Pfizer Inc, UCB

ObjectiveTo describe the efficacy of tofacitinib in reducing pain in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) in a post-hoc analysis of randomised controlled trials.MethodsData were collected from patients in seven tofacitinib studies: six phase III (four RA, two PsA) and one phase II study (AS), and grouped into five analysis populations based on rheumatic disease diagnosis and category of prior inadequate response (IR) to treatment: conventional synthetic disease-modifying antirheumatic drugs-IR (RA and PsA), tumour necrosis factor inhibitors-IR (RA and PsA), or non-steroidal anti-inflammatory drugs-IR (AS). Only patients who received tofacitinib 5 or 10 mg twice daily or placebo were included. Pain assessments included: Patient’s Assessment of Arthritis Pain, Short-Form Health Survey 36v2 Question (Q)7 and Bodily Pain domain, Ankylosing Spondylitis Quality of Life Q9 and Q14, EuroQol Five Dimensions Pain/Discomfort dimension and Bath Ankylosing Spondylitis Disease Activity Index Q2 and Q3. Data were reported to month 6 (placebo to month 3) in the RA and PsA populations, and week 12 (tofacitinib and placebo) in the AS population.ResultsOverall, 3330 patients were included in this analysis. In the RA and PsA populations, pain improvements in tofacitinib-treated patients compared with placebo were observed at the earliest time point assessed and at month 3 (maintained to month 6). In the AS population, pain improvements compared with placebo were observed at week 12.ConclusionTofacitinib was associated with rapid and sustained improvements across multiple pain measures in patients with inflammatory rheumatic musculoskeletal diseases.

ObjectiveTo provide the first direct comparison of patient-reported outcomes (PROs) following treatment with tofacitinib monotherapy versus tofacitinib or adalimumab (ADA) in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA) with inadequate response to MTX (MTX-IR).MethodsORAL Strategy (NCT02187055), a phase IIIB/IV, head-to-head, randomised controlled trial, assessed non-inferiority between tofacitinib 5 mg two times per day monotherapy, tofacitinib 5 mg two times per day+MTX and ADA 40 mg every other week+MTX. PROs assessed included the following: Patient Global Assessment of disease activity (PtGA), Pain, Health Assessment Questionnaire-Disability Index, Functional Assessment of Chronic Illness Therapy-Fatigue and 36-Item Short-Form Health Survey (SF-36) summary and domain scores.ResultsSubstantial improvements from baseline were reported across all PROs in all treatment arms, which, in the majority, met or exceeded minimum clinically important differences. Compared with tofacitinib monotherapy, tofacitinib+MTX combination treatment conferred significantly greater improvements in PtGA, Pain and SF-36 physical component summary scores at month 6. Statistically or numerically greater improvements were often, but not uniformly, reported for combination treatments compared with tofacitinib monotherapy at other time points.ConclusionTreatment with tofacitinib+MTX, ADA+MTX and tofacitinib monotherapy resulted in clinically meaningful improvements in PROs in MTX-IR patients with RA. These were comparatively greater with combination treatments versus tofacitinib monotherapy, although differences between treatment arms were small, limiting our ability to confer clinical meaning.Trial registration numberNCT02187055.

Background:Tofacitinib is an oral Janus kinase inhibitor for the treatment of psoriatic arthritis (PsA). It was approved in the United States (US) in December 2017 for use in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs).Objectives:This analysis of real-world data assessed demographic and baseline clinical characteristics, as well as treatment persistence/adherence, in patients (pts) with PsA who had newly initiated tofacitinib treatment.Methods:This retrospective cohort study included pts aged ≥18 years in the Truven MarketScan™ US Commercial and Medicare Supplemental Claims and Encounters database with ≥1 tofacitinib claim (first = index) between 14 December 2017–30 April 2019, and PsA diagnoses (≥1 inpatient or ≥2 outpatient [30–365 days apart]) on or within 12 months pre-index. Pts were continuously enrolled for 12 months pre-index and 6 months post-index, with no pre-index claims for tofacitinib. Pt demographic and clinical characteristics on the day of index, history of advanced therapy treatment (≥1 claim for biologic DMARDs or apremilast within 12 months pre-index) and tofacitinib treatment regimen (monotherapy or combination therapy [≥1 claim for conventional synthetic DMARDs or apremilast on or within 90 days post-index]) were recorded. Outcomes at 6 months post-index included tofacitinib persistence (Results:Of 17 321 pts receiving tofacitinib, 440 pts met the inclusion criteria for the overall cohort, with 315 pts included in the sub-cohort. In the overall cohort, pts were mostly female, with a mean age of 52.3 years and a mean PsA duration of 738 days (data not shown). Most pts were exposed to ≥1 advanced therapy within 12 months pre-index (mean = 1.1; range = 0–4); most commonly secukinumab (Table 1). Overall, 60.7% of pts received monotherapy and 39.3% of pts received tofacitinib combination therapy post-index; most commonly methotrexate (data not shown). At 6 months post-index, persistence was similar in pts receiving tofacitinib monotherapy vs combination therapy; adherence was slightly lower in pts receiving tofacitinib monotherapy vs combination therapy (Figure 1). Results were similar in the sub-cohort (Table 1, Figure 1).Table 1.History of advanced therapy on or within 12 months pre-index in pts with PsAAll pts(N=440)Pts with no RAa(N=315)Pts exposed to advanced therapy, n (%)b Any advanced therapyc336 (76.4)241 (76.5) Secukinumab113 (25.7)91 (28.9) Adalimumab93 (21.1)58 (18.4) Apremilast81 (18.4)59 (18.7) Etanercept70 (15.9)47 (14.9)Unique advanced therapy prescriptions Mean (SD)1.1 (0.8)1.1 (0.8) Median (IQR)1 (1–2)1 (1–2) Range0–40–4Number of unique advanced therapies, n (%) 0104 (23.6)74 (23.5) 1214 (48.6)153 (48.6) 2100 (22.7)73 (23.2) ≥322 (5.0)15 (4.8)aExcludes pts with a diagnosis of RA on or within 12 months pre-index and within 6 months post-index; bPts with ≥1 claim for biologic DMARDs or apremilast within 12 months pre-index; cOther advanced therapies reported in IQR, interquartile range; N, number of pts per cohort; n, number of pts per category; SD, standard deviationFigure 1Conclusion:This analysis of US-based claims data indicated that pts newly initiated tofacitinib treatment an average of 2 years after PsA diagnosis, with the majority (>60%) of pts receiving tofacitinib as monotherapy. High levels of persistence and adherence to tofacitinib were observed 6 months after treatment initiation. Findings were similar when pts with PsA who also had a diagnosis of RA were excluded. Data were limited in that claims data cannot confirm that pts took the medication for which they filed a claim.Acknowledgements:Study sponsored by Pfizer Inc. Medical writing support was provided by Gemma Turner, CMC Connect, and funded by Pfizer Inc.Disclosure of Interests:Philip J Mease Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Genentech, Janssen, Novartis, Pfizer Inc, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer Inc, Sun, UCB, Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer Inc, Sun, UCB, Pamela Young Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, David C Gruben Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Lara Fallon Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Rebecca Germino Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Arthur Kavanaugh Grant/research support from: Pfizer Inc.

Objective: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We compared patient-reported outcomes (PROs) in patients with RA treated with tofacitinib or placebo in combination with conventional disease-modifying antirheumatic drugs (DMARDs). Methods: In a 12-month, Phase 3, randomized controlled trial (ORAL Sync), patients (n=795) with active RA and previous inadequate response to therapy with ≥1 conventional or biologic DMARD were randomized 4:4:1:1 to tofacitinib 5 mg twice daily (BID), tofacitinib 10 mg BID, placebo advanced to 5 mg BID, or placebo to 10 mg BID, in combination with stable background DMARD therapy. PROs included Patient Global Assessment of Arthritis (PtGA), Patient Assessment of Arthritis Pain (Pain), physical function (Health Assessment Questionnaire-Disability Index [HAQ-DI]), health-related quality of life (Short Form-36 [SF-36]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F]), and sleep (Medical Outcomes Study Sleep [MOS Sleep]). Results: At Month 3, statistically significant improvements from baseline versus placebo were reported in PtGA, Pain, HAQ-DI, all eight SF-36 domains, FACIT-F, and MOS Sleep with tofacitinib 10 mg BID, and in PtGA, Pain, HAQ-DI, seven SF-36 domains, FACIT-F, and MOS Sleep with tofacitinib 5 mg BID. Improvements were sustained to Month 12. Significantly more tofacitinib-treated patients reported improvements ≥minimum clinically important differences at Month 3 versus placebo in all PROs, except the SF-36 role-emotional domain (significant for tofacitinib 10 mg BID). Conclusion: Patients with active RA treated with tofacitinib combined with background conventional DMARD therapy reported sustained, significant, and clinically meaningful improvements in PROs versus placebo. (NCT00856544) This article is protected by copyright. All rights reserved.

Background:Depression/anxiety are common in RA pts. SF-36 MCS ≤38 can identify probable major depressive disorder and/or probable generalised anxiety disorder (pMDD/pGAD) in RA pts. Tofacitinib is an oral JAK inhibitor for the treatment of RA.Objectives:To assess pMDD/pGAD prevalence in the tofacitinib RA program and efficacy by baseline (BL) pMDD/pGAD status.Methods:Data from pts receiving tofacitinib, ADA, or PBO were pooled from 5 Phase (P)3 and 1 P3b/4 trials. Demographics/BL characteristics were reported by BL pMDD/pGAD (SF-36 MCS ≤38, presence; >38, absence). Month (M)3/6/9/12 SF-36 MCS change from BL (Δ) was estimated, and % with pMDD/pGAD reported. M3/6/12 efficacy outcomes compared tofacitinib-treated pts by BL pMDD/pGAD.Results:BL pMDD/pGAD was seen in 44.5% (tofacitinib 5 mg BID), 39.8% (tofacitinib 10 mg BID), 45.4% (ADA 40 mg Q2W) and 39.1% (PBO) of pts. pMDD/pGAD pts had higher BL CRP and worse disability, fatigue, pain and sleep vs pts without. SF-36 MCS increases were greater for tofacitinib vs PBO/ADA (Fig 1a). The % of pts with BL pMDD/pGAD who continued to have pMDD/pGAD reduced over time, and was generally lower for tofacitinib vs PBO/ADA (Fig 1b). Regardless of BL pMDD/pGAD, efficacy was generally similar for tofacitinib 5 mg BID (Table) and 10 mg BID.Conclusion:~40% of RA pts had BL pMDD/pGAD. SF-36 MCS improvements were greater for tofacitinib vs PBO/ADA. With tofacitinib, % of pts with SF-36 MCS ≤38 reduced by ~60% at M12. Tofacitinib efficacy was similar in pts with/without BL pMDD/pGAD. Limitations include using SF-36 MCS to identify probable rather than confirmed MDD or GAD. Future research using gold standard psychiatric interviews to validate use of SF-36 MCS ≤38 is needed.Table.M3/6/12 efficacy with tofacitinib 5 mg BID, by BL pMDD/pGADaSF-36 MCS ≤38SF-36 MCS >38OR (95% CI)P valueACR20 (%)b,cM355.157.90.89 (0.74, 1.08)0.2330M661.762.80.96 (0.79, 1.16)0.6511M1258.458.60.99 (0.80, 1.22)0.9279ACR50 (%)b,cM325.929.20.85 (0.70, 1.03)0.1022M636.038.00.92 (0.76, 1.11)0.3724M1233.834.30.98 (0.80, 1.20)0.8366ACR70 (%)b,cM310.111.00.91 (0.69, 1.18)0.4704M616.516.51.00 (0.79, 1.26)0.9901M1218.317.51.06 (0.83, 1.34)0.6560DAS28-4(ESR))b,cM35.47.40.72 (0.49, 1.05)0.0872M65.98.50.68 (0.49, 0.94)0.0199*M128.011.90.64 (0.47, 0.89)0.0073**ΔHAQ-DI, LS meanc,dSF-36 MCS ≤38SF-36 MCS >38Difference (95% CI)P valueM3-0.41-0.430.01 (-0.04, 0.06)0.6008M6-0.49-0.48-0.01 (-0.06, 0.04)0.6617M12-0.52-0.52-0.01 (-0.06, 0.05)0.8475*paBL pMDD/pGAD = SF-36 MCS ≤38;bLogistic regression fit;cFor PBO pts advancing to tofacitinib post-M3, only PBO data were included;dMixed-effects linear model fitΔ, change from baseline; ACR, American College of Rheumatology; BID, twice daily; BL, baseline; CI, confidence interval; DAS28-4(ESR), Disease Activity Score in 28 joints, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire-Disability Index; LS, least squares; M, month; MCS, Mental Component Summary score; OR, odds ratio; P, Phase; pGAD, probable generalised anxiety disorder; PBO, placebo; pMDD, probable major depressive disorder; pt, patient; RA, rheumatoid arthritis; SF-36, Short Form-36 health surveyAcknowledgments:Study sponsored by Pfizer Inc. Medical writing support was provided by Sarah Piggott of CMC Connect and funded by Pfizer Inc.Disclosure of Interests:Gustavo Citera Grant/research support from: AbbVie, Amgen, Eli Lilly, Gema, Genzyme, Novartis and Pfizer Inc, Consultant of: AbbVie, Amgen, Eli Lilly, Gema, Genzyme, Novartis and Pfizer Inc, Rakesh Jain Grant/research support from: Allergan, Eli Lilly, Lundbeck, Otsuka, Pfizer Inc, Shire and Takeda, Consultant of: Acadia, Alfasigma, Allergan, Eisai, Eli Lilly, Evidera, Impel, Janssen, Lundbeck, Merck, Neos Therapeutics, Neurocrine Biosciences, Osmotica, Otsuka, Pamlab, Pfizer Inc, Shire, Sunovion, Supernus, Takeda and Teva, Speakers bureau: Alkermes, Allergan, Eli Lilly, Janssen, Lundbeck, Merck, Neos Therapeutics, Neurocrine, Otsuka, Pamlab, Pfizer Inc, Shire, Sunovion, Takeda, Teva and Tris Pharmaceuticals, Fedra Irazoque-Palazuelos Consultant of: Bristol-Myers Squibb, Janssen, Pfizer Inc, Roche and UCB, Renato Guzman: None declared, Hugo Madariaga: None declared, David C Gruben Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Lisy Wang Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Lori Stockert Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Ming-Ann Hsu Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Karina Santana Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Abbas Ebrahim Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Dario Ponce de Leon Shareholder of: Pfizer Inc, Employee of: Pfizer Inc

Real-world data comparing tofacitinib with biologic disease-modifying antirheumatic drugs (bDMARDs) are limited.To compare characteristics, treatment patterns, and costs of patients with rheumatoid arthritis (RA) receiving tofacitinib versus the most common bDMARDs (adalimumab [ADA], etanercept [ETN], and abatacept [ABA]) following a single bDMARD in a U.S. administrative claims database.This study was a retrospective cohort analysis of patients aged ≥ 18 years with an RA diagnosis (ICD-9-CM codes 714.0x-714.4x; 714.81) and 1 previous bDMARD filling ≥ 1 tofacitinib or bDMARD claim in the Truven MarketScan Commercial and Medicare Supplemental claims databases (November 1, 2012-October 31, 2014). Monotherapy was defined as absence of conventional synthetic DMARDs within 90 days post-index. Persistence was evaluated using a 60-day gap. Adherence was assessed using proportion of days covered (PDC). RA-related total, pharmacy, and medical costs were evaluated in the 12-month pre- and post-index periods. Treatment patterns and costs were adjusted using linear models including a common set of clinically relevant variables of interest (e.g., previous RA treatments), which were assessed separately using t-tests and chi-squared tests.Overall, 392 patients initiated tofacitinib; 178 patients initiated ADA; 118 patients initiated ETN; and 191 patients initiated ABA. Tofacitinib patients were older versus ADA patients (P = 0.0153) and had a lower proportion of Medicare supplemental patients versus ABA patients (P = 0.0095). Twelve-month pre-index bDMARD use was greater in tofacitinib patients (77.6%) versus bDMARD cohorts (47.6%-59.6%). Tofacitinib patients had greater 12-month pre-index RA-related total costs versus bDMARD cohorts (all P0.0001) and greatest index use of monotherapy (P = 0.0080 vs. ABA). A similar (all P0.10) proportion of patients were persistent with tofacitinib (42.6%) versus ADA (37.6%), ETN (42.4%), and ABA (43.5%). Mean PDC was 0.55 for tofacitinib versus 0.57 (ADA), 0.59 (ETN), and 0.44 (ABA; P = 0.0003). Adjusted analyses generated similar findings to the unadjusted treatment patterns. Tofacitinib had lower adjusted 12-month post-index mean RA-related total costs ($23,568) versus ADA ($29,278; P0.0001), ETN ($26,885; P = 0.0248), and ABA ($30,477; P0.0001).In this study, tofacitinib was more commonly used as monotherapy and yielded at least comparable persistence and adherence with lower adjusted mean RA-related total costs versus ADA, ETN, and ABA. Further analysis is warranted given the greater 12-month pre-index bDMARD use and RA-related costs for tofacitinib versus bDMARDs.This study was sponsored by Pfizer. Harnett, Gerber, Gruben, Koenig, and Chen are employees and shareholders of Pfizer. Some data reported in this manuscript have been previously presented at the Academy of Managed Care Nexus 2015; Orlando, Florida; October 26-29, 2015, and was submitted in abstract form to the European League Against Rheumatism Congress; London, United Kingdom; June 8-11, 2016. All authors were involved in the conception and design of this study. Harnett and Gruben were involved in data collection and analysis. All authors interpreted the data, critically reviewed and revised the manuscript, and read and approved the final manuscript.

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here we present data from the completed Phase 3 randomised controlled trial (RCT) ORAL Scan (NCT00847613), which evaluated the impact of tofacitinib on patient-reported outcomes (PROs) through 24 months in patients with active RA and inadequate responses to methotrexate (MTX-IR).Patients were randomised 4:4:1:1 to receive tofacitinib 5 or 10 mg twice daily (BID), or placebo advanced to tofacitinib 5 or 10 mg, plus background MTX. Patients receiving placebo advanced to tofacitinib at month 3 (non-responders) or month 6 (remaining patients). Mean changes from baseline in PROs, assessed at months 1-24, included Health Assessment Questionnaire-Disability Index, Patient Global Assessment of disease activity (visual analogue scale [VAS]), Patient Assessment of Arthritis Pain (VAS), health-related quality of life (Short Form-36 version 2), Functional Assessment of Chronic Illness Therapy-Fatigue and Medical Outcomes Study-Sleep.Overall, 539/797 (67.6%) patients completed 24 months' treatment. At month 3, tofacitinib-treated patients reported signi cant (p0.05) mean changes from baseline versus placebo across all PROs, and significantly more patients reported improvements ≥ minimum clinically important differences versus placebo. Improvements in PROs with tofacitinib were sustained to month 24. Following advancement to tofacitinib, placebo-treated patients generally reported changes of similar magnitude to tofacitinib-treated patients.Patients with RA and MTX-IR receiving tofacitinib 5 or 10 mg BID plus MTX reported significant and clinically meaningful improvements in PROs versus placebo at month 3, which were sustained through 24 months.

Background Treatment satisfaction and adherence remain issues affecting outcomes for patients (pts) with rheumatoid arthritis (RA). A better understanding of the reasons for non-adherence, and differences between pt, caregiver and healthcare professional (HCP) views on adherence, may improve decision-making and outcomes. Objectives To survey pts, caregivers and HCPs, in order to investigate pt behaviours and attitudes, and communications between pts, caregivers and HCPs regarding adherence to RA therapy. Methods Surveys were conducted online by Harris Poll between Oct and Nov 2018, among pts/caregivers and HCPs from Australia, Brazil, Canada, Germany, Japan, Spain, Taiwan, UK and US. The pt survey included pts aged ≥18 years with a diagnosis of RA who had taken conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) with biological (b)DMARDs in the past 3 years. The caregiver survey included adults aged ≥18 years who lived with/provided care to a spouse/family member with RA and were involved in ≥2 care activities for a pt with RA who had taken csDMARDs with bDMARDs in the past 3 years. The HCP survey included responses from licensed rheumatologists (orthopaedists in Japan) who saw ≥10 pts with moderate/severe RA per month, ≥10% of whom had been prescribed a bDMARD. A post-weight was applied to raw data to adjust for the relative adult population size of each country vs the total for all 9 countries surveyed. Results In total, 900 pts, 714 caregivers and 840 HCPs responded to the surveys. Overall, 50% of both pts and caregivers reported that pts always took their current RA prescription medications exactly as directed. However, 67% of pts reported that they had not always adhered to dosing regimens (most common deviations: skipping doses [45%]; extending time between doses [44%]; taking other medications without HCP direction [38%]; taking less than the prescribed dose [34%]; dose splitting [31%]; and stopping medications altogether [28%]). Among HCP respondents, 98% reported asking pts about adherence to RA medication, even though 61% felt there was no way of knowing if pts were taking medications as prescribed and, overall, HCPs responded that 64% of pts did not always take RA medication as prescribed. While 87% of HCPs agreed that bDMARDs were most effective when taken in combination with csDMARDs and 92% reiterated this to pts, 62% were concerned that pts take bDMARDs without csDMARDs. Pts and caregivers reported that pts often stopped taking csDMARDs; however, HCPs underestimated the number of non-adherent pts (Figure A). The most common reason given by pts and caregivers for non–adherence to RA medication was difficulty in remembering to take medication; however, concerns about feeling ill and potential side effects were also common (Figure B). Despite this, 47% of pts and 51% of caregivers responded that pts often don’t share all side effects caused by their RA medication with HCPs, while 38% of HCPs believed that pts did not inform them of all side effects. Conclusion This study from a large, multinational cohort of pts with RA, caregivers and HCPs describes medication adherence patterns. Pts on bDMARDs often did not take their background csDMARDs; however, the extent of pt non-adherence was underestimated by HCPs. These results highlight gaps in communication and understanding of non-adherence between pts, caregivers and HCPs. Acknowledgement Study sponsored by Pfizer Inc. Medical writing support was provided by Anthony G McCluskey, PhD, of CMC Connect and funded by Pfizer Inc. Disclosure of Interests James Galloway Consultant for: Pfizer Inc, Ara Dikranian Consultant for: AbbVie, Pfizer Inc, Speakers bureau: AbbVie, Pfizer Inc, Cheryl L Koehn Shareholder of: Arthritis Consumer Experts, Grant/research support from: Canadian Institutes of Health Research, Arthritis Research Canada, St. Paul’s Hospital, Employee of: Arthritis Consumer Experts, David C Gruben Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, John Woolcott Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Sander Strengholt Shareholder of: Pfizer Inc, Employee of: Pfizer Inc

Objectives To describe characteristics, treatment patterns and persistence in patients with RA treated with tofacitinib, an oral Janus kinase inhibitor, in Canadian clinical practice between 1 June 2014 and 31 May 2017. Methods Data were obtained from the tofacitinib eXel support programme. Baseline demographics and medication history were collected via patient report/special authorization forms; reasons for discontinuation were captured by patient report. Treatment persistence was estimated using Kaplan–Meier methods, with data censored at last follow-up. Cox regression was applied to analyse baseline characteristics associated with treatment discontinuation. Results The number of patients with RA enrolled from 2014 to 2017 was 4276; tofacitinib utilization increased during that period, as did the proportion of biologic (b) DMARD-naïve patients prescribed tofacitinib. Of patients who initiated tofacitinib, 1226/3678 (33.3%) discontinued, mostly from lack of efficacy (35.7%) and adverse events (26.9%). Persistence was 62.7% and 49.6% after 1 and 2 years of treatment, respectively. Prior bDMARD experience predicted increased tofacitinib discontinuation (vs bDMARD-naïve, P < 0.001). Increased retention was associated with older age (56–65 years and >65 years vs ⩽45 years; P < 0.05), and time since diagnosis of 15 to 730, 613, 667 and 592 days, respectively. Conclusion Since 2014, tofacitinib use in Canadian patients with RA increased, especially among bDMARD-naïve/post-1 bDMARD patients. Median drug survival was ∼2 years. Likelihood of persistence increased for bDMARD-naïve (vs bDMARD-experienced) patients and those aged ⩾56 (vs ⩽45) years.

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here, the safety and efficacy data from five Phase 2 studies of tofacitinib in patients with RA are summarized. Tofacitinib 1–30 mg twice daily was investigated, as monotherapy and in combination with methotrexate, in patients with RA. Tofacitinib 20 mg once daily was investigated in one study. Tofacitinib 5 and 10 mg twice daily were selected for investigation in Phase 3 studies; therefore, the efficacy and safety of tofacitinib 5 and 10 mg twice daily in Phase 2 studies are the focus of this review. Tofacitinib ≥ 5 mg twice daily was efficacious in a dose‐dependent manner, with statistically significant and clinically meaningful reductions in the signs and symptoms of RA and patient‐reported outcomes. The safety profile was consistent across studies. The efficacy and safety profile of tofacitinib in Phase 2 studies supported its further investigation and the selection of tofacitinib 5 mg twice daily and tofacitinib 10 mg twice daily for evaluation in Phase 3 studies.

Tofacitinib is an oral Janus kinase inhibitor indicated for the treatment of rheumatoid arthritis (RA). Tofacitinib can be administered as a monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (DMARDs). This study describes RA patients' characteristics, treatment patterns, and costs for those initiating tofacitinib treatment as monotherapy or combination therapy, using US claims data from clinical practice.A retrospective cohort analysis of patients aged ≥18 years with RA (International Classification of Diseases, Ninth Revision code 714.xx) and with ≥1 tofacitinib claim in the Truven Marketscan (TM) or the Optum Clinformatics (OC) database. Index was defined as the first tofacitinib fill date (November 2012-June 2014). Patients were continuously enrolled for ≥12 months before and after index. Adherence was assessed using the proportion of days covered (PDC) and medication possession ratio (MPR). Persistence was evaluated using a 1.5× days' supply gap or switch. All-cause and RA-related costs in the 12-month pre- and post-index periods were evaluated. Unadjusted and adjusted analyses were conducted on data on treatment patterns and costs stratified by monotherapy status.A total of 337 (TM) and 118 (OC) tofacitinib patients met the selection criteria; 52.2% (TM) and 50.8% (OC) received monotherapy and 83.7% (TM) and 76.3% (OC) had pre-index biologic DMARD experience. Twelve-month mean PDC values were 0.56 (TM) and 0.53 (OC), and 12-month mean MPR was 0.84 (TM) and 0.80 (OC), with persistence of 140.0 (TM) and 124.6 (OC) days. Between 12-month pre- and post-index periods, mean (SD) 12-month RA-related medical costs decreased by $5784 ($31,832) in TM and $6103 ($25,897) in OC (both, P0.05), whereas total costs increased by $3996 ($30,397) in TM (P0.05) and $1390 ($26,603) in OC. There were no significant differences in adherence, persistence, or all-cause/RA-related costs between monotherapy and combination therapy in unadjusted/adjusted analyses.This analysis adds to the existing tofacitinib knowledge base and will enable informed clinical and policy decision making based on valuable datasets independent of randomized controlled trials.

Adherence to biologic disease-modifying antirheumatic drugs (bDMARDs) among patients with rheumatoid arthritis (RA) is often suboptimal in routine clinical practice. Low or nonadherence can reduce the effectiveness of bDMARD therapies.To evaluate filling of newly prescribed initial bDMARDs for the treatment of RA and evaluate potential for characterizing treatment decisions and patient outcomes.In this retrospective cohort analysis, patients aged ≥ 18 years with an RA diagnosis (ICD-9-CM code 714.xx) were selected from a de-identified database of clinical information from the Electronic Health Record (EHR; Humedica) database linked to health care claims (Optum) from commercial and Medicare Advantage health plans (2007-2013). The first biologic prescription date in EHR was the index date. Patients were categorized as filling the prescription within 30 days (early fillers), 31-180 days (late fillers), or not at all within 180 days (nonfillers) of index date.Of 373 patients meeting inclusion criteria, 170 (45.6%), 59 (15.8%), and 144 (38.6%) were categorized as early fillers, late fillers, and nonfillers, respectively. Most prescriptions were written or ordered for tumor necrosis factor inhibitors (88.7%). Compared with late and nonfillers, early fillers were younger and more likely to be female, with higher pain scores (among those reporting pain scores) and RA severity scores pre-index, and filled more prescriptions for any reason pre-index. More nonfillers (66.0%) were Medicare patients than early (17.7%) and late (35.6%) fillers. During days 0-30 post-index, conventional synthetic DMARD use was greatest for early fillers (45.9%) and lowest among nonfillers (24.3%); however, during days 31-180 post-index, the proportion was highest for late fillers (61.0%) and lowest for nonfillers (35.4%). Of early fillers, 12.9% did not fill/receive a bDMARD after 30 days. Only 23 patients had pre/post-index pain scores, and 47 patients had a rationale for stopping or not filling a bDMARD. In patients with pharmacy and medical coverage for 180 days post-index, early fillers had greater RA-related pharmacy and medical resource use and costs than late and nonfillers combined.These findings confirm a high rate of primary nonadherence to bDMARDs among patients with RA.

Background and objectives: Rheumatoid arthritis (RA) is a chronic, debilitating disease affecting an estimated 1.5 million patients in the US. The condition is associated with a substantial health and economic burden. An economic model was developed to evaluate the cost-effectiveness of tofacitinib (a novel oral Janus kinase inhibitor) versus biologic therapies commonly prescribed in the US for the treatment of RA. Methods: A cost–utility model was developed whereby sequences of treatments were evaluated. Response to treatment was modeled by HAQ change, and informed by a network meta-analysis. Mortality, resource use and quality of life were captured in the model using published regression analyses based on HAQ score. Treatment discontinuation was linked to response to treatment and to adverse events. Patients were modeled as having had an inadequate response to methotrexate (MTX-IR), or to a first biologic therapy (TNFi-IR). Results: The tofacitinib strategy was associated with cost savings compared with alternative treatment sequences across all modeled scenarios (i.e. in both the MTX-IR and TNFi-IR scenarios), with lifetime cost savings per patient ranging from $65,205 to $93,959 (2015 costs). Cost savings arose due to improved functioning and the resulting savings in healthcare expenditure, and lower drug and administration costs. The tofacitinib strategies all resulted in an increase in quality-adjusted life years (QALYs), with additional QALYs per patient ranging from 0.01 to 0.22. Conclusions: Tofacitinib as a second-line therapy following methotrexate failure and as a third-line therapy following a biologic failure produces lower costs and improved quality of life compared with the current pathway of care.

Background: Persistence of active disease in patients (pts) with rheumatoid arthritis (RA) is highly variable following treatment initiation. One possible explanation is the existence of distinct disease activity/response trajectories influenced by baseline variables, such as sociodemographics, disease characteristics and health status.1 Objectives: To identify distinct disease activity trajectories over 12 months and distinguishing baseline factors using pooled data from 3 randomised, controlled Phase 3 (P3) studies of tofacitinib 5 mg twice daily (BID) in pts with active RA who were inadequate responders (IR) to conventional synthetic (cs)DMARDs, with or without prior biologic (b)DMARDs (NCT00847613, NCT00856544 and NCT00853385). Methods: Disease Activity Score in 28 joints, erythrocyte sedimentation rate (DAS28–4[ESR]) data from 3 P3 studies were pooled. A group-based trajectory modelling strategy was applied to find unique longitudinal groups of pts with similar disease activity over time.2 Trajectories were latent models, fit as polynomials. The number of groups and polynomial degree of each group were specified and fit for all combinations of up to 6 groups and up to a 4th degree polynomial; a best-fit model was chosen using Bayesian information criteria. Results: csDMARD-IR/bDMARD-naive pts (n=677) were separated into 5 unique disease activity trajectories (figure 1); csDMARD-IR pts who received prior bDMARDs (n=149) were separated into 4 trajectories (not shown). In the bDMARD-naive pts, Group 5 (3.8%) had the highest predicted baseline DAS (7.3) with minimal improvement (6.4) at Month 12; Group 4 (26.7%) had baseline DAS 7.0, improving to DAS 5.0 at Month 12; Groups 2 (30.4%) and 3 (36.6%) had baseline DAS 5.9 and 6.2, respectively, leading to low DAS (2.9) and moderate DAS (3.9), respectively, at Month 12; Group 1 (2.4%) had the lowest baseline DAS of 4.3, improving to remission (DAS 2.1) at Month 12 (figure 1). The 4 trajectories in csDMARD-IR pts who received prior bDMARDs were similar to Groups 2–5 in bDMARD-naive pts. While baseline demographics were generally similar between bDMARD-naive groups, there were statistically significant differences in baseline disease activity measures and pt-relevant outcomes between groups. Conclusions: It was possible to identify heterogeneous phenotypic subgroups as distinct disease activity trajectories in csDMARD-IR pts treated with tofacitinib. The groups were characterised by differences in disease activity and pt-relevant outcomes, including baseline pain and physical function. Very high disease activity may limit pts’ ability to achieve low disease activity. The identification of distinct trajectory groups could be used to develop personalised treatment optimisation algorithms incorporating clinical and molecular phenotypes. References [1]Barnabe C, et al. PLoS One2015;10:e0135327. [2]Nagin DS. In: Handbook of Quantitative Criminology. New York, NY. Springer 2010:53–67. Acknowledgements: Study sponsored by Pfizer Inc. Medical writing support was provided by R Knight of CMC and funded by Pfizer Inc. Disclosure of Interest: V. Bykerk Grant/research support from: Amgen, BMS, Genentech, UCB, Consultant for: AbbVie, Amgen, BMS, Gilead, Pfizer Inc, Sanofi-Regeneron, UCB, R. van Vollenhoven Grant/research support from: AbbVie, Amgen, BMS, GSK, Pfizer Inc, Roche, UCB, Consultant for: AbbVie, AstraZeneca, Biotest, BMS, Celgene, Crescendo, Eli Lilly, GSK, Janssen, Merck, Novartis, Pfizer Inc, Roche, UCB, Vertex, C. Connell Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, D. Gruben Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, L. Fallon Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, J. Woolcott Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, E. Keystone Grant/research support from: AbbVie, Amgen, BMS, Eli Lilly, Pfizer Inc, Roche, Consultant for: AbbVie, Amgen, BMS, Eli Lilly, Pfizer Inc, Roche

Background Little in-depth qualitative research has been conducted to investigate reasons for rheumatoid arthritis (RA) patient (pt) preferences for different modes of treatment administration. An understanding of pt preference can help physicians personalise therapy recommendations. Objectives To describe potential RA pt preferences for RA treatment modes and reasons for these preferences. Methods Pt demographic information was obtained at screening alongside qualitative interviews conducted using a semi-structured interview guide among adult RA pts in the US, UK, France, Germany, Italy, Spain, Switzerland and Brazil who were currently taking a DMARD (biologic or non-biologic). A 100-point allocation task was used to evaluate the strength of preference (0–100; 100=strong) across 4 treatment modes: oral (OR; once daily), self-injection (SI; weekly), clinic-injection (CI; weekly) and infusion (INF; monthly). Transcripts were developed in English; ATLAS.ti software (v7.5) was used for qualitative coding and analysis. Results 100 interviews (30 US; 10 in each of 7 other countries) were conducted (female: 75.0%; mean age: 53.9 years; mean time since diagnosis: 11.6 years). Current RA medication mode included OR (60.0%), injection (57.0%) and INF (14.0%); 79.0% and 37.0% of pts had experience with injection and INF medications, respectively; 31.0% of pts were taking a combination of biologic and non-biologic DMARDs. Among the 4 treatment modes, OR was allocated the highest mean (standard deviation [SD]) preference points (47.3 [33.1]) and the greatest percentage of pts with a 1st choice rank (57.0%); this was followed by SI (29.7 [27.7]; 29.0%), INF (15.4 [24.6]; 16.0%) and CI (7.5 [14.1]; 2.0%). Preferences by country suggested that the mean points allocated to OR were greater in the US vs other countries. Across all pts and treatment modes, 56.0% of pts had a ‘strong’ 1st choice preference (ie, a pt allocation ≥the mean pts across the 1st ranked choices [70]); of these pts, the majority chose OR (62.5%; SI: 23.2%; INF: 10.7%; CI: 3.6%). Speed of administration was among the most common reasons for choosing OR or SI as a 1st choice, together with ease of administration (OR) and frequency of dosing (SI; table 1). Difficulty remembering was the most common reason for not choosing OR and avoidance of pain was the most common reason for not choosing SI as a 1st choice. Conclusions More pts preferred OR as an RA treatment mode, followed by SI. Rationales for preference included ease of use, concerns about drug interactions, dosing frequency, feelings of control and avoidance of pain and needles. While 56.0% of pts felt strongly about their 1st choice preference, nearly half did not and may be receptive to and benefit from discussions with their healthcare professional and/or pt support groups about RA treatment mode options. Acknowledgements Study sponsored by Pfizer Inc. Editorial support was provided by C Viegelmann of CMC and funded by Pfizer Inc. Disclosure of Interest P. Taylor Grant/research support from: Celgene, Eli Lilly, UCB Pharma, Consultant for: AbbVie, Biogen, Eli Lilly, Galapagos, Janssen, Merck, Pfizer Inc, Roche, Sandoz, Sanofi, UCB Pharma, N. Betteridge Consultant for: Eli Lilly, Grunenthal, Janssen, Pfizer Inc, Roche, Sanofi Genzyme, T. M. Brown Consultant for: Pfizer Inc, Employee of: RTI-HS, J. Woolcott Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, A. Kivitz Consultant for: AbbVie, Celgene, Genentech, Genzyme, Janssen, Merck, Novartis, Pfizer Inc, Sanofi, UCB, Speakers bureau: AbbVie, Celgene, Genentech, Genzyme, Janssen, Merck, Novartis, Pfizer Inc, Sanofi, UCB, C. Zerbini Grant/research support from: Amgen, Celltrion, Eli Lilly, GSK, Merck, Novartis, Pfizer Inc, Sanofi, Consultant for: Eli Lilly, Pfizer Inc, Sanofi, D. Whalley Consultant for: Pfizer Inc, Employee of: RTI-HS, O. Olayinka-Amao Consultant for: Pfizer Inc, Employee of: RTI-HS, C. Chen Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, P. Dahl Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, D. Ponce de Leon Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, D. Gruben Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, L. Fallon Shareholder of: Pfizer Inc, Employee of: Pfizer Inc