Certolizumab pegol, abatacept, tocilizumab or active conventional treatment in early rheumatoid arthritis: 48-week clinical and radiographic results of the investigator-initiated randomised controlled NORD-STAR trial.

BACKGROUND: The optimal first-line treatment in early rheumatoid arthritis (RA) is debated. We compared clinical and radiographic outcomes of active conventional therapy with each of three biological treatments with different modes of action. METHODS: Investigator-initiated, randomised, blinded-assessor study. Patients with treatment-naïve early RA with moderate-severe disease activity were randomised 1:1:1:1 to methotrexate combined with (1) active conventional therapy: oral prednisolone (tapered quickly, discontinued at week 36) or sulfasalazine, hydroxychloroquine and intra-articular glucocorticoid injections in swollen joints; (2) certolizumab pegol; (3) abatacept or (4) tocilizumab. Coprimary endpoints were week 48 Clinical Disease Activity Index (CDAI) remission (CDAI ≤2.8) and change in radiographic van der Heijde-modified Sharp Score, estimated using logistic regression and analysis of covariance, adjusted for sex, anticitrullinated protein antibody status and country. Bonferroni's and Dunnet's procedures adjusted for multiple testing (significance level: 0.025). RESULTS: Eight hundred and twelve patients were randomised. Adjusted CDAI remission rates at week 48 were: 59.3% (abatacept), 52.3% (certolizumab), 51.9% (tocilizumab) and 39.2% (active conventional therapy). Compared with active conventional therapy, CDAI remission rates were significantly higher for abatacept (adjusted difference +20.1%, p<0.001) and certolizumab (+13.1%, p=0.021), but not for tocilizumab (+12.7%, p=0.030). Key secondary clinical outcomes were consistently better in biological groups. Radiographic progression was low, without group differences.The proportions of patients with serious adverse events were abatacept, 8.3%; certolizumab, 12.4%; tocilizumab, 9.2%; and active conventional therapy, 10.7%. CONCLUSIONS: Compared with active conventional therapy, clinical remission rates were superior for abatacept and certolizumab pegol, but not for tocilizumab. Radiographic progression was low and similar between treatments. TRIAL REGISTRATION NUMBER: NCT01491815.

Uptake and effectiveness of newer biologic and targeted synthetic disease-modifying antirheumatic drugs in psoriatic arthritis: results from five Nordic biologics registries.

BACKGROUND: We aimed to describe the uptake of newer biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) in psoriatic arthritis (PsA) in the Nordic countries and to compare their retention and effectiveness. METHODS: Patients with PsA starting a b/tsDMARD in 2012-2020 in five Nordic rheumatology registers were included. Uptake and patient characteristics were described, with comorbidities identified from linkages to national patient registries. One-year retention and 6-month effectiveness (proportions achieving low disease activity (LDA) on the Disease Activity Index for PSoriatic Arthritis based on 28-joint evaluation) for the newer b/tsDMARDs (abatacept/apremilast/ixekizumab/secukinumab/tofacitinib/ustekinumab) were compared with adalimumab through adjusted regression models stratified by treatment course (first, second/third, and fourth or more). RESULTS: In total, 5659 treatment courses with adalimumab (56% biologic-naïve) and 4767 courses with a newer b/tsDMARD (21% biologic-naïve) were included. The uptake of newer b/tsDMARDs increased from 2014 and plateaued in 2018. Patient characteristics appeared similar across treatments at treatment start. Adalimumab was more often used as the first course and newer b/tsDMARDs more often in biologic-experienced patients. Used as a second/third b/tsDMARD, the retention rate and the proportion achieving LDA were significantly better for adalimumab (rate 65%, proportion 59%) compared with abatacept (45%, 37%), apremilast (43%, 35%), ixekizumab (LDA only, 40%) and ustekinumab (LDA only, 40%), but not significantly different from other b/tsDMARDs. CONCLUSION: Uptake of newer b/tsDMARDs occurred mainly in biologic-experienced patients. Regardless of mode of action, only a minority of patients starting a second or later b/tsDMARD course remained on drug and achieved LDA. Superior outcomes for adalimumab indicate that the positioning of newer b/tsDMARDs in the PsA treatment algorithm remains to be established.

Real-world data on seropositive rheumatoid arthritis, then and now: ten-year outcomes of 1151 patients diagnosed between 1997 and 2011.

OBJECTIVES: To study 10-year outcomes in patients with early seropositive rheumatoid arthritis (RA) whether the outcomes improve over time. METHODS: Data of 1754 patients with early RA, diagnosed in 1997-2011 were explored; 66% (n=1151) were seropositive and included in the analyses. Patients were divided into five groups by diagnosis year: 1997-1999, 2000-2002, 2003-2005, 2006-2008 and 2009-2011. Clinical parameters including disease activity and function were compared between the groups. RESULTS: A total of 832 (72%) patients attended the 10-year visit, while 319 did not (e.g. 196 had died and 49 moved). The median (IQR) DAS28 decreased from 2.9 (2.2, 3.7) to 2.3 (1.4, 3.0) (p<0.001) between groups 1997-1999 and 2009-2011. The proportion of patients with 2 or more swollen joints on 46 joint count decreased from 33% to 13%, respectively. Median (IQR) pain decreased from 30 (15, 52) to 25 (6, 51) (p=0.03) and fatigue from 31 (12, 52) to 15 (2, 50) (p=0.012). Median (IQR) dr.global decreased from 20 (5, 40) to 0 (0, 5) p<0.001. The proportion of patients with a HAQ-score of ≤0.5 increased from 39% to 49% (p=0.002). The proportion of patients that had used methotrexate by the 10-year visit increased from 79% to 96% (p<0.001) and the proportion of patients who had used bDMARDs increased from 11% to 28% (p=0.001), respectively. CONCLUSIONS: Several clinical outcomes were better in patients who were diagnosed more recently. More intensive use of medications over time might have contributed to these improvements.

Is seronegative rheumatoid arthritis true rheumatoid arthritis? A nationwide cohort study.

OBJECTIVES: The classification of seronegative arthritides can be challenging. Our aim was to examine the incidence of SpA diagnosis among patients initially diagnosed as seronegative RA. METHODS: Using nationwide Finnish registers from social insurance institutions, we identified all adult patients who were diagnosed with incident seronegative RA [International Classification of Diseases (ICD)-10 code M06] from 1 January 2000 to 31 December 2014. The patients whose diagnoses subsequently changed to the ICD-10 codes of SpA (M07, M45, M46, K50 and K51) were identified in the national care register, until 31 December 2016. RESULTS: A total of 9784 adult seronegative RA patients were identified. Of these, 564 patients had their diagnosis subsequently changed to SpA: 275 (48.7%) patients with PsA, 245 (43.4%) patients with axial SpA and 44 (7.8%) patients with diagnoses related to IBD. The cumulative incidence of SpA diagnoses in 15 years was 10.4% (95% CI 8.9, 12.1) and 8.1% (95% CI 7.1, 9.3) in men and women, respectively. CONCLUSION: This study calls for vigilance in seronegative RA patients, especially those with more atypical presentations, since the diagnosis could change. The possibility of SpA diagnosis should be considered and specifically looked for, as this could impact on management and response to treatment.

Prevalence of calcium pyrophosphate deposition disease in a cohort of patients diagnosed with seronegative rheumatoid arthritis.

OBJECTIVES: We aimed to characterise the clinical and radiographical phenotype of calcium pyrophosphate dihydrate deposition (CPPD) disease in patients initially diagnosed with seronegative RA, and to increase the awareness that CPPD disease can be falsely diagnosed as seronegative rheumatoid arthritis (RA). METHODS: Altogether 435 early seronegative RA patients were clinically diagnosed in a single rheumatology centre and scheduled for a 10-year follow-up. All clinical data were collected and reviewed. CPPD-related arthritis was suspected if a patient had typical radiographical findings and suitable clinical pattern of CPPD or calcium pyrophosphate crystals were found in the synovial fluid. These patients are the subjects of this study. RESULTS: Among 435 seronegative RA patients, 17 patients (3.9%) (baseline mean age 71.2 years, 82% women) with CPPD disease were identified. CPPD resembling clinical patterns in these patients were: chronic CPP crystal inflammatory arthritis (9 patients), acute CPP crystal arthritis (6 patients) and OA with CPPD (2 patients). All had typical radiographical findings of CPPD: Chondrocalcinosis (CC) of triangular fibrocartilage (17 patients [100%]), CC of knee (9 patients [53%]), CC or narrowing of metacarpophalangeal joints (7 patients [41.2%]), CC of metatarsophalangeal joints (4 patients [23.5%]), CC of symphysis pubis (1 patient [5.8%]), CC of glenohumeral joint (1 patient [5.8%]) and scapholunate advanced collapse (5 patients [29.4%]). None of these patients developed typical RA-like erosions. CONCLUSIONS: CPPD disease can mimic seronegative RA at baseline and is important in the differential diagnosis of seronegative arthritis at baseline and during follow-up. The prevalence of CPPD patients in our early seronegative RA patients was 3.9%, the percentage was 7.0% among patients ≥60 years at baseline.

Patients with rheumatoid arthritis facing sick leave or work disability meet varying regulations: a study among rheumatologists and patients from 44 European countries.

OBJECTIVES: To describe and explore differences in formal regulations around sick leave and work disability (WD) for patients with rheumatoid arthritis (RA), as well as perceptions by rheumatologists and patients on the system's performance, across European countries. METHODS: We conducted three cross-sectional surveys in 50 European countries: one on work (re-)integration and social security (SS) system arrangements in case of sick leave and long-term WD due to RA (one rheumatologist per country), and two among approximately 15 rheumatologists and 15 patients per country on perceptions regarding SS arrangements on work participation. Differences in regulations and perceptions were compared across categories defined by gross domestic product (GDP), type of social welfare regime, European Union (EU) membership and country RA WD rates. RESULTS: Forty-four (88%) countries provided data on regulations, 33 (75%) on perceptions of rheumatologists (n=539) and 34 (77%) on perceptions of patients (n=719). While large variation was observed across all regulations across countries, no relationship was found between most of regulations or income compensation and GDP, type of SS system or rates of WD. Regarding perceptions, rheumatologists in high GDP and EU-member countries felt less confident in their role in the decision process towards WD (ß=-0.5 (95% CI -0.9 to -0.2) and ß=-0.5 (95% CI -1.0 to -0.1), respectively). The Scandinavian and Bismarckian system scored best on patients' and rheumatologists' perceptions of regulations and system performance. CONCLUSIONS: There is large heterogeneity in rules and regulations of SS systems across Europe in relation to WD of patients with RA, and it cannot be explained by existing welfare regimes, EU membership or country's wealth.

Does early seronegative arthritis develop into rheumatoid arthritis? A 10-year observational study.

OBJECTIVES: To investigate the 10-year clinical course of patients with seronegative arthritis with the emphasis of reclassification of diagnoses when applicable. METHODS: A total of 1030 patients including 435 seronegative cases were classified as early RA in 1997-2005 at Jyväskylä Rheumatology Centre and prospectively scheduled for a ten-year follow-up. Clinical data from the follow-up visits and the case-reports until and including the 10-year visit or death, whichever happened earlier, were retrospectively collected and reviewed with re-classification of the cases when applicable. Descriptive statistics were used. RESULTS: Among the 435 seronegative cases (69 % women, baseline mean age was 59 years), 13 (13/435 [3%]) could be reclassified as seropositive or erosive RA: 4 turned seropositive (2 for ACPA and 2 for RF [> 2x reference level]) and 9 developed erosions typical for RA. Reclassification revealed 68 (16%) cases of polymyalgia rheumatica, 46 (11%) psoriatic arthritis, 45 (10%) osteoarthritis, 38 (8.7%) spondyloarthritis, 15 (3.4%) plausible reactive arthritis, 10 (2.3%) gout, 17 (3.9%) pseudogout, 6 (1.4%) paraneoplastic arthritis, 6 (1.4%) juvenile arthritis, 2 (0.5%) haemochromatosis, 3 (0.7%) ankylosing spondylitis, 2 (0.5%) giant cell arteritis, and 8 miscellaneous diagnoses. The other 140 patients (32%) could not be reclassified in any clear-cut diagnosis and had features of transient arthritis (n=41), seronegative spondyloarthritis (n=47), while 49 remained unspecified. CONCLUSIONS: Over a 10-year follow-up period, reclassification revealed significant heterogeneity in the diagnosis of seronegative RA. Therefore, seronegative arthritis should not be studied as a homogenous entity.

Survival and safety of infliximab bio-original and infliximab biosimilar (CT-P13) in usual rheumatology care.

OBJECTIVES: Reports to-date indicate similarity between infliximab biosimilar (IB) and infliximab bio-original (IO) in clinical efficacy and safety. This study examines the survival of IB and IO using routinely collected data over a 2-year period. METHODS: Routinely collected clinical data inputted directly in an electronic database at a large rheumatology centre were analysed. Adult patients taking IO or IB for any rheumatological diagnosis were included. Kaplan-Meier survival analyses were used to examine IB and IO survival, with a sub-group analysis among those starting infliximab from 2008 onwards. RESULTS: Out of 395 patients analysed, 53% (n=209) were female; the majority had rheumatoid arthritis (31%) followed by spondyloarthritis (28%). Ninety-nine patients had IB as the first infliximab drug. Patients who started on IB vs. IO as their first infliximab product, had better survival over the first 2 years (log rank=0.001). Discontinuation due to inefficacy was much commoner in IO versus IB users (18 vs. 5%). In patients switching from IO to IB, drug survival was better versus those receiving IB as the first infliximab drug (log rank=0.073). CONCLUSIONS: IB was well-tolerated and comparable to IO, with no additional safety signals identified. The results suggest superior survival of IB over IO over the first 2 years.

A cross-sectional study of vitamin D levels in a large cohort of patients with rheumatic diseases.

The objective of this study is to examine 25-hydroxyvitamin D [25(OH)D] (D-25) levels and associations with patient- and disease-related factors in rheumatic diseases. This is a register-based study of D-25 levels in adult patients seen at the Central Finland Hospital rheumatology clinic (January 2011-April 2015). Demographic, clinical, laboratory, and patient-reported outcomes (PROs) were collected as part of the normal infrastructure of the outpatient clinic and examined for their association with D-25 level. Statistical analysis included descriptive statistics and univariable and multivariable regression analyses adjusting for age and gender. D-25 was measured in 3203 patients (age range 15-91 years, mean 54; 68% female) with diagnoses including RA (n = 1386), unspecified arthralgia/myalgia (n = 413), and connective tissues diseases (n = 213). The overall D-25 mean (SD) level was 78 (31) and median (IQR) 75 (55, 97). At baseline, 17.8% had D-25 deficiency, and only 1.6% severe deficiency  (< 25 nmol/l); 34%/49% had sufficient/optimal D-25 levels. Higher D-25 levels were associated with older age, lower BMI, and regular exercise (all p < 0.001) among other factors. In multivariable analyses, younger age, non-white background, higher BMI, smoking, less frequent exercise (p < 0.001), and first visit to the clinic (p = 0.033) remained significantly associated with D-25 deficiency. Among those with sub-optimal D-25 levels, 64% had improved to sufficient/optimal levels after a median (IQR) of 13 (7.8, 22) months. The proportion of patients with D-25 deficiency in this study was generally low. Older patients had considerably higher D-25 levels compared to younger patients. Lower physical exercise and higher BMI were associated with higher risk of deficiency. The study supports the benefit of strategies to help minimize the risk of D-25 deficiency.

The spectrum of early rheumatoid arthritis practice across the globe: results from a multinational cross sectional survey.

OBJECTIVES: To explore patterns of real-world early RA (ERA) care across countries. METHODS: An online survey was disseminated to practising rheumatologists across Europe and the US, also made accessible on social media between April and May 2015. Survey questions (n=38) assessed the structure and setting of ERA clinics, times to diagnosis and treatment, patient monitoring, guideline use and data recording. RESULTS: A total of 212 rheumatologists from 39 countries (76% European) completed the survey. 62% had an ERA clinic based at a university hospital. Patient referral to rheumatology was mainly (78%) via primary care; 44% had an agreed ERA local referral pathway, 15% a national pathway. Only 16% had dedicated ERA clinics, the majority being practitioners in Northern Europe with access to a local or national referral pathway. Data for research were collected by 42%. Treatment guidelines were followed by the majority, especially rheumatologists practising in Europe. Variations existed in the use of initial DMARDs with treatment decisions reported to be influenced by international/national guidelines in 71%/61%. No significant relationship between country gross national income and the availability of ERA clinics was seen. CONCLUSIONS: This study provides comparative benchmark information regarding the global provision of ERA care. Substantial variations exist in referral and early assessment pathways with guidelines having a most apparent impact in Northern Europe. Provision of an ERA service does not appear to be constrained by cost, with conceptual factors, e.g. clinician engagement, perhaps playing a role. These initial insights could potentially help harmonise ERA management across countries.

Effectiveness and drug survival of TNF-inhibitors in the treatment of psoriatic arthritis: A prospective cohort study.

BACKGROUND AND OBJECTIVES: Tumor necrosis factor (TNF)-inhibitors are used to treat psoriatic arthritis (PsA), but only a limited number of observational studies on this subject have been published thus far. The aim of this research was to analyze the effectiveness and drug survival of TNF-inhibitors in the treatment of PsA. METHODS: PsA patients identified from the National Register for Biologic Treatment in Finland (ROB-FIN) starting their first, second, or third TNF-inhibitor treatment between 2004 and 2014 were included. Effectiveness was measured using ACR and EULAR response criteria and modeled using ordinal logistic regression. Treatment persistence was analyzed using Kaplan-Meier survival analysis and Cox proportional hazards model. RESULTS: The study comprised 765 patients and 990 TNF-inhibitor treatment courses. EULAR moderate treatment responses at 6 months were achieved by 68% and 37% of the users of the first and the second or the third biologic, respectively. The probabilities of discontinuing the treatment within 12 and 24 months were 20% and 28%, respectively. Adjusted treatment responses to all TNF-inhibitors were similar; however, co-therapy with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) was not associated with better effectiveness. Adalimumab [hazard ratio (HR) = 0.62; 95% confidence interval (CI): 0.44-0.88] was superior to infliximab in drug survival while etanercept (HR = 0.77, 95% CI: 0.55-1.1) and golimumab (HR = 0.75, 95% CI: 0.46-1.2) did not differ from it. Co-medication with csDMARDs did not statistically improve drug survival. CONCLUSION: All available TNF-inhibitors showed similar treatment responses with or without csDMARDs. Adalimumab was associated with better drug survival when compared to infliximab.

Go, go, GoTreatIT!

Patient monitoring has been emphasised in rheumatology for decades. However, many obstacles must be overcome before successful monitoring is part of routine care. We describe one model: GoTreatIT.

Delivering a one-stop, integrated, and patient-centered service for patients with rheumatic diseases.

OBJECTIVE: To describe a one-stop, integrated rheumatology service and assess patient satisfaction. METHODS: A descriptive report and patient satisfaction survey of a rheumatology clinic model first developed in 1996 to enhance the patient "journey" through rheumatology services. A patient-satisfaction survey over a 3-week period assessed several aspects of care including quality of services, consultations, and patient education. RESULTS: All referrals are screened by a rheumatologist to pre-schedule laboratory/radiology/other tests for the visit. Upon arrival to the clinic, patients check-in at an electronic desk, and then complete the electronic GoTreatIT monitoring system which assesses patient-reported outcomes. The patient is reviewed by a doctor in a 30- to 60-min consultation, and then by a nurse (for diagnosis/treatment education, vaccinations). An ultrasound machine and capillaroscopy are available for use in the clinic. Patients can be scheduled on the same day to see a nutritionist, physiotherapist, or other heath professionals as necessary. An "early-rheumatoid arthritis treatment path" is available to ensure early, intensive treatment. A patient satisfaction survey revealed high rating of the overall service (90.6/100). None of the patients felt that they lacked education on their disease or medication. Only 6% of the respondents gave negative feedback, reasons including feeling overwhelmed with information or not being given a cause for their symptoms. The multi-disciplinary approach was highly valued and only 3% would rather see a doctor and nurse on separate days. CONCLUSION: The specific clinic model provides an ideal setting for a one-stop service, avoiding unnecessary visits, collecting patient data, and enhancing the patient experience and journey through the system. Where possible, the specific clinic model could be used or adapted to build similar models in other rheumatology departments. The clinic model could also form the basis for services in other specialties dealing with chronic conditions.

Long-term outcomes of destructive seronegative (rheumatoid) arthritis - description of four clinical cases.

BACKGROUND: Seronegative rheumatoid arthritis is associated with a milder course of progression compared to seropositive disease. However, long-term follow-up data of the clinical course of seronegative rheumatoid arthritis are sparse. Here we describe four cases with a rare disease entity of aggressive destructive seronegative (rheumatoid) arthritis with 20-35 years of follow-up. CASE PRESENTATION: The four cases are women with an initial presentation of seronegative rheumatoid arthritis in 1980-1996 and have received disease-modifying anti-rheumatic drugs since the diagnosis. In all cases, the condition has been refractory to treatments and evolved into a severe disease with destructions of the wrists, sub-talar and ankle joints, as well as large joints but not small joints of fingers and toes. All cases are negative with regard to rheumatoid factor, anti-cyclic citrullinated peptide antibodies and antibodies against carbamylated proteins. CONCLUSIONS: This report adds to the existing literature, making the reader aware of this sub-type of inflammatory arthritis which despite being seronegative, can have devastating disease consequences. The report highlights the need for further research into this field in order to better understand this disease sub-type, the pathogenesis, disease course and outcomes.

Cost-effectiveness of biologic compared with conventional synthetic disease-modifying anti-rheumatic drugs in patients with rheumatoid arthritis: a Register study.

OBJECTIVE: The aim of this study was to explore the cost-effectiveness of biological DMARDs (bDMARDs) compared with conventional synthetic DMARDs (csDMARDs) for RA using real-world data from Finnish registers. METHODS: RA patients starting their first bDMARD and comparator patients using csDMARDs during 2007-11 were obtained from the National register of biologic treatments in Finland and the Jyväskylä Central Hospital patient records. Propensity score matching was applied to adjust for differences between bDMARD and csDMARD users. Effectiveness was measured in quality-adjusted life years (QALY) and based on the register of biologic treatments in Finland and Jyväskylä Central Hospital patient records, whereas the direct costs were obtained from relevant Finnish national registers. Patients were followed up for 2 years, and both costs and effectiveness for the second year were discounted at 3%. The incremental cost-effectiveness ratio (ICER) with 95% CI was calculated based on bootstrapped mean costs and effectiveness. RESULTS: Of 1581 RA patients meeting study inclusion criteria, 552 bDMARD and 220 csDMARD users were included in analyses after matching. Mean costs for bDMARDs and csDMARDs were €55 371 and €24 879, while mean effectiveness was 1.23 and 1.20 QALYs, respectively. Consequent ICER was €902 210/QALY. Results were confirmed in sensitivity analyses. CONCLUSION: The high incremental cost and the small, non-significant difference in effectiveness resulted in high ICER, suggesting that bDMARDs are not cost-effective. Regardless of matching, latent confounders may introduce bias to the results.

Is long-term radiographic joint damage different between men and women? Prospective longitudinal data analysis of four early RA cohorts with greater than 15 years follow-up.

OBJECTIVES: To examine gender-related differences in radiographic joint damage in rheumatoid arthritis (RA) using four prospective early RA cohorts. METHODS: Radiographs of patients from four early prospective RA cohorts were examined. The extent of joint damage in hands and feet was assessed by three evaluators according to the Larsen score (0-100). Descriptive statistics and two-way bootstrap ANOVA with time as a covariate were employed. RESULTS: A total of 312 patients were included who had at least 15 years of follow up: 68 from the Rheumatism Foundation Hospital in Heinola in the 1970s (Heinola1970), 117 patients from Lund University Hospital in the 1980s, (Lund1980), and 81 and 46 patients from Jyväskylä Central Hospital in the 1980s (JYV1980) and the 1990s (JYV1990), respectively. Median Larsen scores in seropositive women vs. men were 43 vs. 48 (p=0.57), 37 vs. 34 (p=0.25), 31 vs. 9.5 (p=0.008), and 3.0 vs. 4.0 (p=0.34) in the Heinola1970, Lund1980, JYV1980, and JYV1990 cohorts, respectively. The corresponding figures in seronegative women vs. men were 12 vs. 23 (p=0.59), 2.0 vs. 8.0 (p=0.36), and 1.0 vs. 1.5 (p=0.63), in the Lund1980, JYV1980 and JYV1990 cohorts. All Heinola patients were seropositive. CONCLUSIONS: After a 15-20 year follow-up period, RA joint damage appears comparable in women and men. The results suggest that management should not differ at least based on gender.

A survey on the medication adherence to methotrexate among rheumatoid arthritis patients treated with self-administered biologic drugs.

OBJECTIVES: Methotrexate (MTX) is the most widely used co-therapy among rheumatoid arthritis (RA) patients using biological disease-modifying anti-rheumatic drugs (bDMARDs). However, adherence to MTX treatment remains a concern with estimates of adherence ranging from 59 to 63%. The objective of this study was to assess the self-reported use and adherence to MTX among RA patients treated with self-administered bDMARDs. METHODS: An electronic questionnaire survey was conducted in 68 community pharmacies in Finland. To be included in the present study patients had to be at least 18 years old, be currently using a self-administered bDMARD and be diagnosed with RA. The results are presented as medians with their respective interquartile ranges (IQR) or percentages. RESULTS: Of the 158 pharmacy customers asked to participate, 135 (85%) consented to complete the questionnaire. The included respondents were predominantly female (72%) with a median age of 55 (IQR 44-65) and rheumatic activity of 3 out of 10 (IQR 2-6.5). The majority (91%) of the included respondents were using TNF-inhibitors and 27% of all patients were on biologic monotherapy. MTX was currently used by 45% of the respondents while 50% were past users. Of the current MTX users, 6.8% identified themselves moderately non-adherent to the treatment. MTX-related adverse events were important factors associated with nonadherence and discontinuation of the treatment. CONCLUSIONS: Only 45% of the respondents were currently using MTX co-therapy, but the ones who did were adherent to their treatment. Self-reported adherence may however be subject to social desirability bias and recall bias.