Objective.To examine the influence of concomitant methotrexate (MTX) with adalimumab (ADA) on outcomes in patients with psoriatic arthritis (PsA) using data from an observational study of ADA.Methods.Data from a German noninterventional study of patients with PsA starting treatment with ADA were analyzed retrospectively for effects of concomitant MTX on key outcomes, including Disease Activity Score-28 joints, tender and swollen joint counts, skin assessments, and safety. Patients were categorized into those with symptoms of axial involvement and those with no symptoms of axial involvement as judged by the examining clinician.Results.A total of 1455 patients met the study criteria, 296 with axial involvement (ADA monotherapy = 165; plus MTX = 131) and 1159 with no axial involvement (ADA monotherapy = 658; plus MTX = 501). ADA, alone or combined with MTX, resulted in strong and comparable reductions in disease activity measures in patients with and those without axial disease over 24 months of therapy. In multiple regression analyses, concomitant MTX did not affect joint or skin outcomes in either the group with axial manifestations or the group without axial disease. Neither adverse event rates nor withdrawal rates were significantly influenced by concomitant MTX.Conclusion.ADA is an effective treatment option for patients with PsA with or without axial involvement. Compared with ADA monotherapy, the use of concomitant MTX with ADA does not improve articular or skin outcomes in patients with PsA regardless of axial symptoms. Trial registration: Clinicaltrials.govNCT01111240

Anemia of chronic disease (ACD) is a frequent complication of chronic inflammation in rheumatoid arthritis (RA). Recombinant human erythropoietin (rHuEpo) has been shown to be effective in correcting ACD, although with a variable rate of nonresponders. The first aim of this trial was to improve the response to rHuEpo by parenteral iron supplementation in cases of iron-deficient erythropoiesis (IDE). An additional goal was the evaluation of the zinc protoporphyrin content of erythrocytes (ZnPP), the soluble transferrin receptor (sTrfR) serum concentration, and the hemoglobin (Hb) content of reticulocytes (CHr) in stimulated erythropoiesis as diagnostic and prognostic parameters. Thirty RA patients with ACD were treated with subcutaneous 150 IU rHuEpo/kg body weight twice weekly. Intravenous iron supplementation (200 mg iron sucrose once weekly) was added in cases of IDE (n=23), which was defined by the presence of two of three criteria: saturation of transferrin (TrfS) < or =15%, hypochromic erythrocytes (HypoE) > or =10%, and a serum ferritin (Fn) concentration < or =50 microg/l. All 28 completers met the treatment goal, with an increase of the median Hb concentration from 10.3 g/dl to 13.3 g/dl. Epo treatment and iron supplementation was safe and well tolerated in all patients. Monitoring of Fn, TrfS, and HypoE every other week allowed a successful correction of anemia. Retrospective analysis of the evaluable parameters (CHr, sTrfR, and ZnPP) revealed no additional benefit for predicting or monitoring IDE in this setting, although the one or other may be advantageous in other therapeutic situations.

We evaluated a combined physician and patient questionnaire designed for identifying early rheumatoid arthritis (RA) and spondyloarthritis (SpA) in a cohort of 220 patients supposed for admission to an early arthritis clinic (EAC). The documents including personal and basis demographic data, referral diagnosis, questions related to RA and SpA classification criteria, functional limitations and previous diagnostic and therapeutic attempts were fax-transmitted to referring practices and returned before first EAC appointment. 125 referrals before introduction of the questionnaire served as controls. We found that a functional impairment of the hands provided more accurate prediction of RA than reports on morning stiffness or joint swelling. No clinical data proved predictive for SpA. We observed an unintended increase in the prescription of analgesics/NSAID and corticosteroids. In conclusion, questionnaires as designed here may provide substantial information for diagnosis of RA, but also imply the risk of unmeant therapeutic attempts.

Summary Anaemia affects quality of life and radiographic outcome in rheumatoid arthritis (RA). In a cross‐sectional study with 779 patients, we assessed the prognostic potential of the major haematopoietic regulators, hepcidin and erythropoietin, comparing their serum concentrations with respect to different anaemia types, inflammatory activity, anti‐cytokine‐specific treatment effects and iron deficiency (ID) indices. The results showed that clinical disease activity was more closely associated with haemoglobin levels than with anti‐tumour necrosis factor‐alpha or interleukin 6 receptor effects. In ID, hepcidin was suppressed, independently of inflammation. Erythropoietin levels were inappropriately low in relation to the degree of anaemia, but, in contrast to low haemoglobin, not directly associated with joint damage progression. Hepcidin and erythropoietin levels are intimately connected with inflammation and ID. Interventional studies on these important targets are already in progress.

Background In active psoriatic arthritis (PsA) the efficacy of TNF-inhibitors (TNFi) has been proven in randomized clinical trials (RCT). Methotrexate (MTX) co-medication can improve the therapeutic benefit of TNFi in rheumatoid arthritis (RA), but its role in PsA remains unclear. Thus, distinct patterns of disease manifestations such as peripheral joint and axial involvement might influence the choice of co-medication, treatment response and drug adherence differently in PsA. Accordingly, an appropriate study on the impact of MTX on TNFi treatment in PsA has to consider the confounding effects of the distinct disease manifestations on outcome measures. Methods Data of a large German multicentre, prospective observational study (n=1455) with active PsA patients treated with Adalimumab (ADA) in routine care was analysed. Patients were stratified in a cohort with exclusive peripheral arthritis (pPsA) i.e. no evidence for axial involvement, enthesitis and dactylitis and in a group with additional musculoskeletal manifestations (aPsA) for separate analysis. Safety and efficacy of ADA-monotherapy were analysed and compared to the results obtained by add-on treatment to MTX pre-medication. Besides documentation of demographic data, disease activity assessments (number of swollen (SJC), tender joints (TJC), disease activity score 28 (DAS28)) were calculated at baseline, month 3, 6, 12, 24. Treatment adherence (no withdrawal) and reasons for withdrawal were documented. In addition, those patients who stopped MTX after combinational treatment and those who added MTX (in ADA-monotherapy) were analysed. Step-wise regression analysis for influence of MTX on patient-outcome was calculated. Results DAS28 values after 24 months of ADA treatment is independent from concomitant MTX use in both groups (pPsA: ADA+MTX 2.58, ADA-Monotherapy 2.70; aPsA: ADA+MTX 2.82, ADA-Monotherapy 2.79 respectively). Treatment adherence was comparable in both groups as well as withdrawal rates due to lack of efficacy or adverse events. Moreover, treatment responses remained robust to changes of MTX co-medication either by discontinuation in combined TNFi therapy or by addition to TNFi-monotherapy. In step-wise regression analysis no parameters for MTX were found to influence patient-outcome. Conclusions In both, axial and peripheral involvement of PsA, co-medication of MTX added to TNFi treatment with ADA has no relevant impact on efficacy, safety or treatment adherence. Not even the addition of MTX to ongoing TNFi treatment or termination of MTX in combinational therapy with TNFi exhibits any influence on outcome. RCTs are needed to confirm the data. Disclosure of Interest F. Behrens Grant/research support: Abbvie Deutschland GmbH & Co.KG, M. Köhm Grant/research support: Abbvie Deutschland GmbH & Co.KG, U. Arndt: None declared, B. Wittig Employee of: Abbvie Deutschland GmbH & Co.KG, G. Greger Employee of: Abbvie Deutschland GmbH & Co.KG, D. Thaci Grant/research support: Abbvie Deutschland GmbH & Co.KG, E. Scharbatke Grant/research support:...

Nowadays undisputed is the effectiveness of early and long-standing DMARD therapy in the presence of active rheumatoid arthritis on disease progression and avoidance of structural joint changes. "Early" is defined as immediate initiation of drug therapy after diagnosis of rheumatoid arthritis. "Long-term" refers to a mostly life-long therapy, which even in the case of remission should be continued for at least 1 year. Clinical and laboratory routine controls during DMARD therapy are absolutely necessary. "DMARDs" summarize disease-modifying antirheumatic drugs such as methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, aurum but also the TNF-blockers infliximab and etanercept. In cases of disease remission with combination drug therapy, corticosteroids and NSAID should be discontinued in a timely manner ahead of DMARDs to ensure that the reduction of clinical symptoms is not steroid controlled. DMARD therapy should end at least 6 months prior to conception.

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