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Introduction: This post hoc analysis of the phase 3 rheumatoid arthritis (RA) filgotinib clinical trial program assessed the effect of filgotinib on body mass index (BMI) in patients with RA and the impact of BMI on the efficacy and safety of filgotinib. Methods: FINCH 1–3 were randomized, double-blind, active- or placebo-controlled phase 3 trials of filgotinib 100 and 200 mg in patients with RA (N = 3452). BMI assessments included the mean change from baseline in BMI and the proportion of patients whose BMI increased by incremental thresholds. Efficacy measures included American College of Rheumatology (ACR) 20/50/70 response and low disease activity/remission according to Disease Activity Score 28 using C-reactive protein. The exposure-adjusted incident rate (EAIR) of adverse events (AEs) was assessed by baseline BMI, using integrated data from the FINCH 1–4 and the phase 2 DARWIN 1–3 studies (total filgotinib exposure = 8085 patient-years). Results: Mean change from baseline in BMI over time was similar across treatment arms. In most patients, BMI increased by ≤ 1 or 2 kg/m2 at both weeks 12 and 24, regardless of treatment group or baseline BMI; few patients had increases of ≥ 4 kg/m2. For most efficacy measures, filgotinib 200 mg was more efficacious than filgotinib 100 mg or active comparators or placebo across BMI subgroups. For the higher filgotinib dose, the EAIR of serious treatment-emergent AEs, venous thrombotic and embolic events, and major adverse cardiovascular events increased with increasing BMI. Conclusions: Filgotinib did not lead to substantial changes in BMI, and BMI did not appear to affect the efficacy of filgotinib. Trial Registration: ClinicalTrials.gov identifiers: NCT02889796, NCT02873936, NCT02886728, NCT03025308, NCT01888874, NCT01894516, NCT02065700. Plain Language Summary: Some rheumatoid arthritis treatments cause patients to gain weight or are less effective in patients with obesity than in patients without obesity. Also, obesity can make rheumatoid arthritis worse. Filgotinib is a rheumatoid arthritis treatment that was evaluated in seven randomized clinical studies (FINCH 1–4 and DARWIN 1–3). We investigated whether filgotinib causes changes in weight and whether body mass index (BMI) affects the efficacy or safety of filgotinib. We analyzed how the BMI of patients who participated in FINCH 1, 2, or 3 changed over time. Most patients had a small increase in BMI (around 1–2 kg/m2) after 24 weeks of filgotinib treatment. This change in BMI was not affected by patients' BMI at baseline. Baseline BMI did not impact the efficacy of filgotinib, which was assessed using standard measures of disease activity. Filgotinib was more effective than other rheumatoid arthritis treatments and placebo in all patients, regardless of BMI subgroup. Using safety data from all seven clinical studies (FINCH 1–4 and DARWIN 1–3), we found that some adverse events occurred more often in patients with obesity (a BMI of ≥ 30 kg/m2) than in those without obesity. The increased adverse events included venous thrombotic and embolic events and major adverse cardiovascular events, for which obesity is a known risk factor. These results show that filgotinib did not substantially change BMI (which increased by around 1–2 kg/m2 in most patients), and that baseline BMI did not affect the efficacy of filgotinib. [ABSTRACT FROM AUTHOR]

Introduction: Etanercept (ETN) has been shown to slow radiographic progression of rheumatoid arthritis (RA) and psoriatic arthritis (PsA) in clinical trials. This real-world, non-interventional study assessed radiographic progression in patients with RA or PsA treated with ETN for ≤ 36 months in outpatient care in Germany (NCT01623752). Methods: Patients with RA or PsA attended ≤ 10 visits across two study phases (phase 1: seven visits, baseline to month 18; phase 2: three visits until month 36). Radiographs were taken at baseline (Rx1), months 12–18 (Rx2), and/or months 30–36 (Rx3). Historic radiographs (Rx0) taken 12–48 months pre-baseline were also evaluated (if available). The primary endpoint was the change in modified total Sharp score (mTSS). The erosion score (ES) and joint space narrowing score (JSN) were also evaluated. Results: Overall, 1821 patients were enrolled (RA: n = 1378; PsA: n = 440). In patients with Rx1 and Rx2 (RA: n = 511; PsA: n = 167), the mean mTSS remained stable for both disease groups, and the annualized median change in mTSS was 0. In patients with Rx0, Rx1, and Rx2 (RA: n = 180; PsA: n = 47), annualized radiographic progression in mTSS, ES, and JSN was larger in the pre-ETN treatment phase than during ETN treatment in both disease groups. The percentage of patients with radiographic non-progression was higher during ETN treatment versus pre-ETN. Improvement in clinical disease activity and patient-reported outcomes was also observed. Conclusions: This was the first real-world, non-interventional study to report systematically collected radiographic data in a large cohort of patients with RA or PsA under treatment with a biologic. In patients with available radiographic data, mean radiographic progression was lower and the proportion of patients without progression was greater during ETN treatment than in the pre-ETN period. Plain Language Summary: Rheumatoid arthritis (RA) and psoriatic arthritis (PsA) are diseases in which inflammation can lead to damage in the joints. X-ray images can show whether the disease gets worse; this is called radiographic progression. Etanercept is a drug that acts on the body's immune system and can reduce inflammation in the joints. In clinical studies, radiographic progression was slower in people with RA or PsA who received etanercept compared with people who received another drug called methotrexate. In this study, we wanted to know how radiographic progression changes in people in Germany who receive etanercept as part of their routine treatment. A total of 1378 people with RA and 440 people with PsA received etanercept for up to 36 months. We observed little to no radiographic progression for most people during the study. Radiographic progression was worse before people started taking etanercept. More people had no radiographic progression while taking etanercept compared with before they started treatment. The proportion of people who responded to treatment with etanercept as measured by the number of painful joints increased throughout the study. Overall, people felt that their health improved after they started taking etanercept. This was the first large study in which we investigated how radiographic progression changes when people with RA or PsA start taking etanercept as part of their routine treatment. We observed a slowing or halting of radiographic progression in most people and an improvement in their overall health. [ABSTRACT FROM AUTHOR]

The original article can be found online at https://doi.org/10.1007/s40744-022-00491-4.Correction: Rheumatol Ther (2023) 10:117–133https://doi.org/10.1007/s40744-022-00491-4A video abstract is now available for this publication. The video abstract can also be accessed on the article's Figshare page here: https://doi.org/10.6084/m9.figshare.23709666.Graph: Video AbstractBy Siegfried Wassenberg; Rolf Rau; Thilo Klopsch; Anja Plenske; Jürgen Jobst; Pascal Klaus; Thomas Meng and Peter-Andreas LöschmannReported by Author; Author; Author; Author; Author; Author; Author; Author [Extracted from the article]

This document is a correction notice for an article titled "Etanercept is Effective and Halts Radiographic Progression in Rheumatoid Arthritis and Psoriatic Arthritis: Final Results from a German Non-interventional Study (PRERA)." The original article contained incorrect keywords, which have been updated to "Rheumatoid arthritis; Psoriatic arthritis; Radiographic progression; Etanercept; Noninterventional study." The authors of the article are Siegfried Wassenberg, Rolf Rau, Thilo Klopsch, Anja Plenske, Jürgen Jobst, Pascal Klaus, Thomas Meng, and Peter-Andreas Löschmann. The correction notice provides a link to the original article for further reference. [Extracted from the article]

Golimumab (GLM) has shown its efficacy and safety in various clinical trials. We aimed to assess the effect of GLM on socio economic and health economic parameters in daily clinical practice. Rheumatology offices in Germany. Analysis of socio economic and health economic parameters of the non-interventional, multicentre, prospective study GO-NICE. Analyses were performed in an exploratory manner using descriptive statistical methods. Further, p-values on socio economic variables were calculated based on one-sample t-test on the differences between baseline and follow-up visits. A total of 1458 patients were evaluable, of whom a total of 664 patients completed the 24-month observation period. The proportions of hospitalizations decreased statistically significantly (p ≤.05) from 10.4/7.6/14.0% at baseline (BL) to 1.7/2.2/0.8%, and the in-patient rehabilitations decreased from 3.3/3.7/7.5% at BL to 0.6/1.8/2.1% at month 24 in patients with RA, PsA, and AS. When considering a 30-day period, the mean number of sick leave days decreased statistically significantly (p ≤.005) from 4.0 at BL to 0.9 at month 24 (greatest improvement in RA), and the mean number of days with impaired capability decreased statistically significantly (p ≤.001) from 14.9 at BL to 4.5 at month 24 (greatest improvement in patients with AS). There was also a reduction in the number of consultations and remedies. This evaluation shows improvements in socio economic and health economic parameters on GLM treatment. [ABSTRACT FROM AUTHOR]

Introduction: While golimumab (GLM) has demonstrated efficacy in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) in several randomized clinical trials with biologic-naïve patients, observational data from biologic-experienced patients are sparse. We aimed to assess the effectiveness of GLM used as the first-, second-, or at least third-line biologic agent in RA, PsA, and AS patients in a real-world setting. Methods: Post hoc analysis of the noninterventional, prospective, 24-month GO-NICE study of RA, PsA, and AS patients who initiated GLM 50 mg subcutaneously once monthly in a real-world setting in Germany. Results: In 1454 patients with RA, PsA, or AS, GLM was administered as the first-line (n = 305, 286, 292, respectively), second-line (n = 104, 136, 130, respectively), or at least third-line (n = 64, 79, 58, respectively) biologic agent. In RA patients (n = 473), the time since first diagnosis was 9.7, 10.1, and 14.3 years, respectively. The DAS28 score at BL was 5.0, 4.9, and 5.1 in patients using GLM as a first-, second-, and third-line biologic agent, respectively, and dropped significantly in all groups. After 3 months of treatment, 27.5%, 19.5%, and 14.5% of patients were in remission; the corresponding values after 24 months were 45.3%, 50.0%, and 33.3%, respectively. In PsA patients (n = 501), time since fist diagnosis was 12.4, 13.7, and 13.8 years, respectively. Based on PsARC, a response was achieved at 24 months in the first-, second-, and third-line use of GLM in 76.4%, 51.0%, and 50.0% of the patients. In AS patients (n = 480), the time since first diagnosis was 9.4, 9.8, and 12.4 years in patients using GLM as the first-, second-, and at least third-line biologic agent, respectively. After 24 months of treatment, the mean BASDAI scores decreased significantly (p < 0.001 vs. BL) to 2.1, 2.9, and 2.9 in the patients using GLM as the first-, second-, and at least third-line treatment, respectively. Conclusions: Golimumab is an effective treatment in patients with RA, PsA, and AS, irrespective of any pretreatment with biologic agents. Study Registration: ClinicalTrials.gov NCT01313858. [ABSTRACT FROM AUTHOR]

The TNF inhibitor golimumab (GLM) is a treatment option in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). The GO-NICE study assessed patient-reported outcomes (PRO) in patients newly treated with monthly GLM 50 mg subcutaneously (SC) under real-life conditions in Germany. A prospective non-interventional study with 24-month observation per patient was conducted at 158 sites. Available for analysis were 1,458 patients, 474 with rheumatoid arthritis (RA: 54.9 ± 13.4 years, 72.8% females, 60.4% biologic-naïve), 501 with psoriatic arthritis (PsA: 50.5 ± 12.1 years, 54.1% females; 47.5% biologic-naïve), and 483 with ankylosing spondylitis (AS: 43.6 ± 12.3 years, 66.5% males; 58.4% biologic-naïve). A total of 664 patients completed follow-up to month 24. An improvement of QoL by EuroQoL EQ-5D-3L was seen after 6 months and was maintained over 24 months. The patients' health state today (EQ visual analog scale) improved statistically significantly (p < 0.0001 vs. BL) from 51.0 at baseline (BL) to 63.4 (RA), from 48.4 to 64.3 (PsA) and from 46.8 to 66.5 (AS). Functional ability (FFbH) improved significantly (p < 0.003 vs. BL) from BL 68.2 to 76.1 points (RA), from 69.0 to 76.8 points (PsA), and from 69.0 to 78.5 points (AS). The mean FACIT-Fatigue score increased significantly (p < 0.0001 vs. BL) from BL 32.4 to 38.3 points (RA), from 30.0 to 35.9 points (PsA), and from 29.9 to 37.9 points after 24 months (AS); p < 0.0001 vs. BL each. On treatment with GLM SC once monthly, significant improvements in patient-reported QoL parameters were noted in a very similar manner in all three diseases.Trial registration ClinTrials.gov Identifier: NCT01313858. Registered March 14, 2011; https://clinicaltrials.gov/ct2/show/record/NCT01313858. [ABSTRACT FROM AUTHOR]

Glucocorticoids reduce disease activity and retard progression of joint damage in rheumatoid arthritis, but current recommendations discourage their use because of drug adverse effects. This study examined the effects of low-dose glucocorticoids on weight gain and hypertension, which are among the more worrisome adverse effects for patients and rheumatologists. Visual Abstract. The Effect of Low-Dose Glucocorticoids Over Two Years on Weight and Blood Pressure in Rheumatoid Arthritis: Individual Patient Data From Five Randomized Trials Glucocorticoids reduce disease activity and retard progression of joint damage in rheumatoid arthritis, but current recommendations discourage their use because of drug adverse effects. This study examined the effects of low-dose glucocorticoids on weight gain and hypertension, which are among the more worrisome adverse effects for patients and rheumatologists. Background: Weight gain and hypertension are well known adverse effects of treatment with high-dose glucocorticoids. Objective: To evaluate the effects of 2 years of low-dose glucocorticoid treatment in rheumatoid arthritis (RA). Design: Pooled analysis of 5 randomized controlled trials with 2-year interventions allowing concomitant treatment with disease-modifying antirheumatic drugs. Setting: 12 countries in Europe. Patients: Early and established RA. Intervention: Glucocorticoids at 7.5 mg or less prednisone equivalent per day. Measurements: Coprimary end points were differences in change from baseline in body weight and mean arterial pressure after 2 years in intention-to-treat analyses. Difference in the change of number of antihypertensive drugs after 2 years was a secondary end point. Subgroup and sensitivity analyses were done to assess the robustness of primary findings. Results: A total of 1112 participants were included (mean age, 61.4 years [SD, 14.5]; 68% women). Both groups gained weight in 2 years, but glucocorticoids led, on average, to 1.1 kg (95% CI, 0.4 to 1.8 kg; P  < 0.001) more weight gain than the control treatment. Mean arterial pressure increased by about 2 mm Hg in both groups, with a between-group difference of −0.4 mm Hg (CI, −3.0 to 2.2 mm Hg; P  = 0.187). These results were consistent in sensitivity and subgroup analyses. Most patients did not change the number of antihypertensive drugs, and there was no evidence of differences between groups. Limitation: Body composition was not assessed, and generalizability to non-European regions may be limited. Conclusion: This study provides robust evidence that low-dose glucocorticoids, received over 2 years for the treatment of RA, increase weight by about 1 kg but do not increase blood pressure. Primary Funding Source: None. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to assess the safety and efficacy of long-term low-dose glucocorticoids (GCs) in RA. Methods A protocolised systematic review and meta-analysis (PROSPERO No. CRD42021252528) of double-blind, placebo-controlled randomised trials (RCTs) comparing a low dose of GCs (≤ 7.5mg/day prednisone) to placebo over at least 2 years was performed. The primary outcome investigated was adverse events (AEs). We performed random-effects meta-analyses and used the Cochrane RoB tool and GRADE to assess risk of bias and quality of evidence (QoE). Results Six trials with 1078 participants were included. There was no evidence of an increased risk of AEs (incidence rate ratio 1.08; 95% CI 0.86, 1.34; P  = 0.52); however, the QoE was low. The risks of death, serious AEs, withdrawals due to AEs, and AEs of special interest did not differ from placebo (very low to moderate QoE). Infections occurred more frequently with GCs (risk ratio 1.4; 1.19–1.65; moderate QoE). Concerning benefit, we found moderate to high quality evidence of improvement in disease activity (DAS28: −0.23; −0.43 to −0.03), function (HAQ −0.09; −0.18 to 0.00), and Larsen scores (–4.61; −7.52 to −1.69). In other efficacy outcomes, including Sharp van der Heijde scores, there was no evidence of benefits with GCs. Conclusion There is very low to moderate QoE for no harm with long-term low dose GCs in RA, except for an increased risk of infections in GC users. The benefit-risk ratio might be reasonable forusing low-dose long-term GCs considering the moderate to high quality evidence for disease-modifying properties. [ABSTRACT FROM AUTHOR]

Introduction: Patients with rheumatoid arthritis (RA) who are treated with adalimumab (ADA) are offered a proprietary patient support program (PSP, AbbVie Care). The main objective of this study was to examine the effectiveness of ADA on RA treatment course over time in the context of PSP utilization. Methods: PASSION was a 78-week post-marketing observational study of RA patients with an insufficient response to ≥1 DMARD newly initiating ADA in routine clinical care that was conducted in Europe, Israel, Mexico, Puerto Rico, and Australia. One prior biologic DMARD was allowed. The primary endpoint was percentage of patients achieving the minimal clinically important difference (MCID; improvement of ≥0.22 compared to baseline) in Health Assessment Questionnaire (HAQ) Disability Index (HAQ-DI) at week 78. Additionally, multiple clinical and patient-reported outcomes (PROs) were evaluated over time. Patients were categorized based on their participation in the PSP: ever (PSP users) vs. never (PSP non-users). Safety events were monitored throughout the study. Results: Overall, 42.8% of PSP users achieved the MCID in HAQ-DI at week 78 (improvement of at least 0.22 compared to baseline). From 1025 enrolled, 48.7% of patients were PSP users while treated with ADA. The percentage of patients achieving MCID in the HAQ-DI was higher in PSP users vs. PSP non-users (48.1 vs. 37.8%) at week 78 ( p < 0.001, NRI). Most of the studied clinical outcomes and PROs showed significant improvements ( p < 0.05) from baseline to week 78 favoring PSP users over PSP non-users. Conclusions: In patients with moderate-to-severe RA who initiated ADA, improvements in clinical, functional, and PROs were achieved in real-world settings with significantly greater improvements among PSP users in comparison with PSP non-users. Funding: AbbVie. Trial registration: ClinicalTrials.gov identifier, NCT01383421. [ABSTRACT FROM AUTHOR]

Background: The optimal dose of rituximab in combination with leflunomide in patients with rheumatoid arthritis (RA) is not known. Methods: In Part 1 (previously reported) of the investigator-initiated AMARA study (EudraCT 2009-015950-39; ClinicalTrials.gov NCT01244958), improvements at week (W)24 were observed in patients randomized to rituximab + leflunomide compared with placebo + leflunomide. In the study reported here (Part 2), Part 1 responders received rituximab 500 or 1000 mg at W24/26 plus ongoing leflunomide. Patients were randomized at baseline to their eventual W24 treatment group. The Part 2 primary outcome was the mean Disease Activity Score-28 joints (DAS28) at W52, based on the last observation carried forward (LOCF) analyses and a two-sided analysis of variance. Patient-reported outcomes (PROs) and adverse events were evaluated. Results: Eighty-three patients received rituximab at W24/26 (31 rituximab→rituximab 1000 mg; 29 rituximab→rituximab 500 mg; 10 placebo→rituximab 1000 mg; 13 placebo→rituximab 500 mg). At W52, there were no significant differences in DAS28 between rituximab doses in patients originally treated with rituximab or those originally treated with placebo. In the Part 1 placebo group, the higher rituximab dose was associated with greater improvements in ACR response rates and some PROs. Adverse events were similar regardless of rituximab dose. Conclusions: Retreatment with rituximab 500 mg and 1000 mg showed comparable efficacy, whereas an initial dose of rituximab 500 mg was associated with lower response rates versus 1000 mg. Reduced treatment response with the lower dose in patients initially treated with placebo may have been influenced by small numbers and baseline disease activity. [ABSTRACT FROM AUTHOR]

Objective: In active early rheumatoid arthritis (RA), glucocorticoids are often used for bridging, due to the delayed action of methotrexate. This study was undertaken to compare the effect of 3 bridging strategies, including high‐dose and low‐dose prednisolone, on radiographic and clinical outcomes. Methods: Adult RA patients from 1 rheumatology hospital and 23 rheumatology practices who presented with moderate/high disease activity were randomized (1:1:1) to receive 60 mg prednisolone (high‐dose prednisolone [HDP]) or 10 mg prednisolone (low‐dose prednisolone [LDP]) daily (tapered to 0 mg within 12 weeks) or placebo. The 12‐week intervention period was followed by 40 weeks of therapy at the physicians' discretion. The primary outcome measure was radiographic change at 1 year measured using the total modified Sharp/van der Heijde score (SHS). Disease activity was assessed with the Disease Activity Score in 28 joints using the erythrocyte sedimentation rate (DAS28‐ESR). Results: Of 395 randomized patients (HDP, n = 132; LDP, n = 131; placebo, n = 132), 375 (95%) remained in the modified intention‐to‐treat analysis. Mean ± SD changes in SHS scores in the 3 groups after 1 year were comparable: mean ± SD 1.0 ± 2.0 units in the HDP group, 1.1 ± 2.2 units in the LDP group, and 1.1 ± 1.5 units in the placebo group. The primary analysis showed no superiority of HDP compared to placebo (estimated difference of the mean change −0.04 [95% confidence interval (95% CI) −0.5, 0.4]). At week 12, the mean DAS28‐ESR differed: −0.6 (95% CI −1.0, −0.2) for HDP versus placebo; –0.8 (95% CI −1.2, −0.5) for LDP versus placebo. At week 52, there was no significant difference in DAS28‐ESR between the 3 groups (range 2.6–2.8). Serious adverse events occurred similarly often. Conclusion: Short‐term glucocorticoid bridging therapy at a high dose showed no benefit with regard to progression of radiographic damage at 1 year. [ABSTRACT FROM AUTHOR]

Objective To investigate the efficacy and safety of rituximab + LEF in patients with RA. Methods In this investigator-initiated, randomized, double-blind, placebo-controlled phase 3 trial, patients with an inadequate response to LEF who had failed one or more DMARD were randomly assigned 2:1 to i.v. rituximab 1000 mg or placebo on day 1 and 15 plus ongoing oral LEF. The primary efficacy outcome was the difference between ≥50% improvement in ACR criteria (ACR50 response) rates at week 24 (P  ≤ 0.025). Secondary endpoints included ACR20/70 responses, ACR50 responses at earlier timepoints and adverse event (AE) rates. The planned sample size was not achieved due to events beyond the investigators' control. Results Between 13 August 2010 and 28 January 2015, 140 patients received rituximab (n  = 93) or placebo (n  = 47) plus ongoing LEF. Rituximab + LEF resulted in an increase in the ACR50 response rate that was significant at week 16 (32 vs 15%; P  = 0.020), but not week 24 (27 vs 15%; P  = 0.081), the primary endpoint. Significant differences favouring the rituximab + LEF arm were observed in some secondary endpoints, including ACR20 rates from weeks 12 to 24. The rituximab and placebo arms had similar AE rates (71 vs 70%), but the rituximab arm had a higher rate of serious AEs (SAEs 20 vs 2%), primarily infections and musculoskeletal disorders. Conclusion The primary endpoint was not reached, but rituximab + LEF demonstrated clinical benefits vs LEF in secondary endpoints. Although generally well tolerated, the combination was associated with additional SAEs and requires monitoring. Trial registration EudraCT: 2009-015950-39; ClinicalTrials.gov: NCT01244958. [ABSTRACT FROM AUTHOR]

Tocilizumab (TCZ) and tumour necrosis factor inhibitors (TNFi) are recommended for the treatment of rheumatoid arthritis (RA) in patients with inadequate response (IR) to prior disease-modifying antirheumatic drugs (DMARDs). This retrospective analysis assessed the efficacy of TCZ and TNFi, alone or in combination with DMARDs, in 1603 patients with IR to previous treatment with either DMARDs (DMARD-IR) and/or TNFi (TNFi-IR), initiating treatment with TCZ or a TNFi, managed in routine clinical practice. Patients were grouped according to treatment history and treatment initiated: DMARD-IR patients initiating treatment with TCZ + DMARD (DMARD-IR TCZ) or TNFi + DMARD (DMARD-IR TNFi), DMARD-IR and/or TNFi-IR patients initiating treatment with TCZ monotherapy (TCZ mono) or TNFi monotherapy (TNFi mono), and TNFi-IR patients initiating treatment with TCZ + DMARD (TNFi-IR TCZ) or TNFi + DMARD (TNFi-IR TNFi). Patients initiating treatment with TCZ generally had more severe disease and longer disease duration compared with the corresponding TNFi group. Significantly more patients achieved remission (DAS28 ESR <2.6) in the TCZ groups compared with corresponding TNFi groups (DMARD-IR, TCZ 44.0 % vs. TNFi 29.6 %; monotherapy, TCZ 37.2 % vs. TNFi 30.2 %; TNF-IR, TCZ 41.3 % vs. TNFi 19.2 %; p < 0.001 for all comparisons). More patients achieved moderate-good responses (EULAR criteria) in the TCZ treatment groups (79-85 %) compared with TNFi treatment groups (65-81 %). Patient-reported outcomes showed greater improvements in TCZ compared with TNFi groups. In patients with inadequate response to DMARDs and/or TNFi treated in routine clinical practice, TCZ in combination with DMARDs or as monotherapy resulted in significantly more patients achieving remission and more marked improvements in patient-reported outcomes compared with TNF inhibitors. [ABSTRACT FROM AUTHOR]

Background: Osteoarthritis (OA) is a heterogeneous group of conditions with disturbed integrity of articular cartilage and changes in the underlying bone. The pathogenesis of OA is multifactorial and not just a disease of older people. Hydroxychloroquine (HCQ) is a disease-modifying anti-rheumatic drug (DMARD) typically used for the treatment of various rheumatic and dermatologic diseases. Three studies of HCQ in OA, including one abstract and one letter, are available and use a wide variety of outcome measures in small patient populations. Despite initial evidence for good efficacy of HCQ, there has been no randomized, double-blind, and placebo-controlled trial in a larger patient group. In the European League Against Rheumatism (EULAR), evidence-based recommendations for the management of hand OA, HCQ was not included as a therapeutic option because of the current lack of randomized clinical trials. Methods/Design: OA TREAT is an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled trial. A total of 510 subjects with inflammatory and erosive hand OA, according to the classification criteria of the American College of Rheumatology (ACR), with recent X-ray will be recruited across outpatient sites, hospitals and universities in Germany. Patients are randomized 1:1 to active treatment (HCQ 200 to 400 mg per day) or placebo for 52 weeks. Both groups receive standard therapy (non-steroidal anti-inflammatory drugs [NSAID], coxibs) for OA treatment, taken steadily two weeks before enrollment and continued further afterwards. If disease activity increases, the dose of NSAID/ coxibs can be increased according to the drug recommendation. The co-primary clinical endpoints are the changes in Australian-Canadian OA Index (AUSCAN, German version) dimensions for pain and hand disability at week 52. The co-primary radiographic endpoint is the radiographic progression from baseline to week 52. A multiple endpoint test and analysis of covariance will be used to compare changes between groups. All analyses will be conducted on an intention-to-treat basis. Discussion: The OA TREAT trial will examine the clinical and radiological efficacy and safety of HCQ as a treatment option for inflammatory and erosive OA over 12 months. OA TREAT focuses on erosive hand OA in contrast to other current studies on symptomatic hand OA, for example, HERO [Trials 14:64, 2013]. [ABSTRACT FROM AUTHOR]

The objective of this study is to compare the radiological progression in patients with rheumatoid arthritis (RA) diagnosed in the 1980s with those of the late 1990s until 2005 and to evaluate prognostic factors. Ninety-two RA patients who were firstly seen in our clinic from 1997 to 2005 were identified. As a control group, 89 RA patients from 1986 to 1990 were matched for the criteria disease duration (mean, 22 ± 17 months), age, and number of x-ray controls. Radiological damage was measured by the Ratingen score (RS). The baseline RS of the 1997–2005 group was significantly lower (mean, 3.8 ± 8.7 vs 7.7 ± 13.0; p < 0.0001) and showed less radiological progression during follow-up than the 1986–1990 group (ΔRS/year of 0.95 ± 2.19 vs. 5.69 ± 8.43; p < 0.0001). In the later group, more patients (73 vs. 28 %) had methotrexate (MTX). Twenty-one (23 %) of the patients in the later group received biological drugs. However, the subgroup 1997–2000 ( n = 29), before the approval of TNF-inhibitors, had already lower baseline RS in comparison to 1986–1990 (2.7 ± 4.9; p < 0.001). Multivariate analysis showed that early start of MTX (before or directly after first consultation) was a predictor of favorable outcome ( p < 0.005), as were low erythrocyte sedimentation rate at baseline and belonging to the later group. In contrast, neither treatment with glucocorticoids or biological drugs nor the overall rate of MTX or other disease-modifying antirheumatic drug use was predictive. Radiological damage is markedly diminished in RA patients seen since mid of the 1990s. Early treatment with MTX seems to be the key factor for this improved prognosis. [ABSTRACT FROM AUTHOR]

The objective of this study was to use data from a noninterventional study to evaluate the effectiveness of adalimumab in rheumatoid arthritis (RA) patients during routine clinical practice and to explore the potential impact of patient and disease characteristics in response to adalimumab therapy. A total of 2,625 RA patients with specified data at baseline (prior to initiating adalimumab treatment) and 12 months entered this study between April 2003 and March 2009. We evaluated response to adalimumab therapy and conducted stepwise regression and subgroup analyses of factors influencing therapeutic response. During the 1-year adalimumab treatment period, disease activity decreased from a baseline mean disease activity score-28 joints (DAS28) of 5.9-3.9, while functional capacity improved from 59.0 to 68.4 Funktionsfragebogen Hannover (FFbH) percentage points. In multivariate regression models, high baseline DAS28 was the strongest positive predictor for decrease in disease activity, and high baseline functional capacity was associated with reduced gains in functional capacity. Male gender was a positive predictor of therapeutic response for both disease activity and functional capacity, while older age and multiple previous biologics were associated with a reduced therapeutic response. Subset analyses provided further support for the impact of baseline DAS28, FFbH, and prior biologic therapy on therapeutic response during treatment. We conclude that treatment with adalimumab leads to decreased disease activity and improved function during routine clinical practice. Patients with high disease activity and low functional capacity are particularly benefitted by adalimumab therapy. [ABSTRACT FROM AUTHOR]

The article considers the hazard risk of developing or worsening heart failure among patients with rheumatoid arthritis who have been treated with tumor necrosis factor (TNF) alpha inhibitors. According to the authors, three-year heart failure incidence rates among patients with cardiovascular disease was at 2.2 percent, while those without cardiovascular problem at the start of treatment was at 0.4 percent. They conclude that TNF alpha inhibitor treatment is more beneficial than harmful.

Background: Osteoarthritis (OA) is a heterogeneous group of conditions with disturbed integrity of articular cartilage and changes in the underlying bone. The pathogenesis of OA is multifactorial and not just a disease of older people. Hydroxychloroquine (HCQ) is a disease-modifying anti-rheumatic drug (DMARD) typically used for the treatment of various rheumatic and dermatologic diseases. Three studies of HCQ in OA, including one abstract and one letter, are available and use a wide variety of outcome measures in small patient populations. Despite initial evidence for good efficacy of HCQ, there has been no randomized, double-blind, and placebo-controlled trial in a larger patient group. In the European League Against Rheumatism (EULAR), evidence-based recommendations for the management of hand OA, HCQ was not included as a therapeutic option because of the current lack of randomized clinical trials. Methods/design: OA TREAT is an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled trial. A total of 510 subjects with inflammatory and erosive hand OA, according to the classification criteria of the American College of Rheumatology (ACR), with recent X-ray will be recruited across outpatient sites, hospitals and universities in Germany. Patients are randomized 1:1 to active treatment (HCQ 200 to 400 mg per day) or placebo for 52 weeks. Both groups receive standard therapy (non-steroidal anti-inflammatory drugs [NSAID], coxibs) for OA treatment, taken steadily two weeks before enrollment and continued further afterwards. If disease activity increases, the dose of NSAID/coxibs can be increased according to the drug recommendation. The co-primary clinical endpoints are the changes in Australian-Canadian OA Index (AUSCAN, German version) dimensions for pain and hand disability at week 52. The co-primary radiographic endpoint is the radiographic progression from baseline to week 52. A multiple endpoint test and analysis of covariance will be used to compare changes between groups. All analyses will be conducted on an intention-to-treat basis. Discussion: The OA TREAT trial will examine the clinical and radiological efficacy and safety of HCQ as a treatment option for inflammatory and erosive OA over 12 months. OA TREAT focuses on erosive hand OA in contrast to other current studies on symptomatic hand OA, for example, HERO [Trials 14:64, 2013]. Trial Registration: ISRCTN46445413, date of registration: 05-10-2011. [ABSTRACT FROM AUTHOR]