Objectives To evaluate the influence of the SARS-CoV-2 pandemic on the adherence of patients with inflammatory rheumatic diseases (IRD) to their immunomodulatory medication during the three-months lockdown in Germany. Methods From March 16th until June 15th 2020, IRD patients from private practices and rheumatology departments were asked to answer a questionnaire addressing their behaviour with respect to their immunomodulating therapy. Eight private practices and nine rheumatology departments which included rheumatology primary care centres and university hospitals participated. 4252 questionnaires were collected and evaluated. Results The majority of patients (54%) were diagnosed with rheumatoid arthritis, followed by psoriatic arthritis (14%), ankylosing spondylitis (10%), connective tissue diseases (12%) and vasculitides (6%). The majority of patients (84%) reported to continue their immunomodulatory therapy. Termination of therapy was reported by only 3% of the patients. The results were independent from the type of IRD, the respective immunomodulatory therapy and by whom the patients were treated (private practices vs rheumatology departments). Younger patients (<60 years) reported just as often as older patients to discontinue their therapy. Conclusion The data show that most of the patients continued their therapy in spite of the pandemic. A significant change in behavior with regard to their immunomodulatory therapy was not observed during the three months of observation. The results support the idea that the immediate release of recommendation of the German Society of Rheumatology were well received, supporting the well-established physician-patient-relationship in times of a crisis.

Einstellung von Patienten mit entzündlich-rheumatischenErkrankungen zur immunsuppressiven Therapie im Rahmen der COVID-19 Pandemie -eine Situationsanalyse Seit 11.03.2020 spricht die WHO von einer Coronavirus Pandemie. Verursacht wird die Coronavirus Krankheit (CO-VID-19) durch das SARS-CoV-2 Virus. Die Erkrankung manifestiert sich als Infektion der Atemwege mit den Leitsymptomen Fieber und Husten. Bei 81 % Patienten ist der Verlauf mild, 14 % erkranken schwer und 5% der Patienten kritisch [1]. Das erste Auftreten wurde im Dezember 2019 in der Millionenstadt Wuhan in der Provinz Hubei (China) dokumentiert. Am 07.04.2020 meldete die Johns-Hopkins-Universität bereits 1.348.628 registrierte, die Welt umspannende Infektionsfälle. Die Letalität lag zu diesem Zeitpunkt der Pandemie bei 5,6 % (n = 74.834 an Covid-19 Verstorbene). Zu diesem Zeitpunkt war bereits klar, dass das Vorhandensein und die Zahl von Komorbiditäten (wie Diabetes mellitus, arterielle Hypertonie und koronare Abb. 1 9 Verteilung der Studienzentren und deren Aktivität (regionenbezogen) Zeitschrift für Rheumatologie 4 · 2020 379 Hot Topics Abb. 2 8 Prozentuale Altersverteilung der bis zum 07.04.2020 befragten Patienten Abb. 3 8 Prozentuale Verteilung der entzündlich-rheumatischen Erkrankungen der bis zum 07.04.2020 befragten Patienten Herzerkrankungen) mitentscheidend ist für das Outcome der Patienten [2]. Trotz vieler klinischer Parallelen zu einer viralen Infektion der oberen und unteren Atemwege mit Influenzaviren, SARS oder MERS, alle mit einer vergleichbaren initialen Klinik (Husten, Fieber, Cephalgien und Myalgien), dem Übertragungsweg (Tröpfcheninfektion) und der sehr variablen Symptomatik von symptomlos bis zu kurzen letalen Verläufen, gab es bis zu dieser Pandemie keine Handlungsempfehlungen basierend auf evidenzbasierten Daten für Patienten mit entzündlich-rheumatischen Erkrankungen. Dasselbe galt für die Bedeutung oder den Einfluss einer dauerhaften immunsuppressiven oder immunmodulierenden Therapie. Wöchentlich zunehmende Daten aus China und Italien zeigen aber, dass schwere Verlaufsformen und Komplikationen in jedem Alter auftreten können, und bei Patienten ab dem 60. Lebensjahr und solchen mit chronischen Grunderkrankungen deutlich häufiger. InderletztenInfluenza-Saison(40. Meldewoche (MW) 2018 bis 20. MW 2019) wurden laut dem Robert-Koch-Institut (RKI) 182.000 labordiagnostisch bestätige Fälle dokumentiert. Davon waren 98,5 % durch Influenza A verursacht. Lediglich bei 0,7 % der Patienten konnte Influenza Typ B nachgewiesen werden. Dies legt laut RKI die Vermutung nahe, dass eine höhere Immunität gegen Influenza Typ B herrscht und könnte dadurch begründet sein, dass die letzte Grippe-Saison vordergründig durch Influenza Typ B verursacht wurde. 33 % der Fälle wurden in der Altersgruppe 35-59 dokumentiert. 25 % der Betroffenen waren über 59 Jahre. Die Altersgruppe 5-14 Jahre war dagegen am wenigsten betroffen. Unter den diagnostisch bestätigten Fällen befanden sich 40.000 hospitalisierte Fälle. Diese teilten sich auf in 54 % Betroffene übe...

Aim: To analyze the quality of life (QoL), work productivity and activity impairment (WPAI) and healthcare resource utilization (HCRU) in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) patients receiving golimumab under routine clinical settings in Germany. Materials & methods: Prospective observational study, GO-ART, analyzed changes in WPAI, QoL and HCRU during 24 months of golimumab therapy. Results: Seven hundred and forty-eight patients (RA = 250, PsA = 249 and AS = 249) were enrolled. Substantial improvements in WPAI scores presenteeism, activity impairment and total work productivity impairment and QoL were observed at month three and were maintained through month 24. Fewer patients had disease-related hospitalizations and consulted physician at month 24 than at the baseline. Conclusion: Golimumab induces sustained improvements in WPAI and QoL and reduces healthcare resource utilization in RA, PsA and AS.

Retroperitoneal fibrosis is a disorder in which the retroperitoneal fat is the site of a subacute and chronic inflammatory reaction and is subsequently replaced by dense fibrotic tissue. Rheumatoid nodules are chronic granulomata occurring at sites of pressure and movement, both near the body surface and internally. A 55-year-old sales-manager was admitted to radiation synovectomy after a 5 year history of excessive right and left knee effusions. There were no other clinical or laboratory abnormalities. The patient did not respond to either radioisotope synoviorthesis using radioactive Yttrium (90 Y), or to open synovectomy and prostetic surgery of the right knee. One year later, surgery of left ureter was necessary. Histological findings revealed the diagnosis of Ormond's disease. Comparative histological studies of synovial membrane of knee and retroperitoneal tissues showed local necrosis, fibrin deposition, lining cell proliferation, and infiltration by lymphocytes. Diagnosis of arthritis complicated by retroperitoneal rheumatoid nodules and retroperitoneal fibrosis was made. Serum rheumatoid factor has been negative. For the last 3 years, the patient has been on successful therapy with azathioprine. Rheumatoid nodules of the retroperitoneum have vanished completely and frequency of knee effusions decreased.

Background:Non-interventional studies (NIS) are essential instruments in pharmaceutical research not only for pharmaceutical companies but also for regulatory authorities or reimbursement bodies in Germany.Aside from direct costs caused by a disease, German sick funds as well as health authorities have a keen interest in indirect costs, such as costs derived from loss of work productivity.Objectives:It is the aim of this study to show the benefit of Golimumab (GLM) in work productivity and activity for RA, AS and PsA patients in Germany. The analysis was performed using the validated indication-specific Work Productivity Activity Impairment (WPAI) Questionnaire as primary endpoint. The WPAI is rated to be the most psychometrically validated and frequently used instrument for measuring of health-related work-productivity.Methods:As primary endpoint, the change of work productivity impairment and ability for daily activities in month 3 (V1) versus baseline visit (V0) was evaluated.All 4 subscores of the WPAI were analysed: disease related absence from work (absenteeism), working while sick (presenteeism), total work productivity impairment (TWPI) and activity impairment with TWPI as primary score.In addition, an evaluation of the activity impairment in the mITT population (modified-Intention-To-Treat) was performed.As exploratory endpoint, the change in work productivity/activity impairment after 6 months and 12 months versus baseline as measured by WPAI for PsA, RA and AS patients treated with Golimumab in German clinical practice was evaluated.Results:Of 748 patients (100%) who started treatment with Golimumab at V0 (baseline), 666 (89.0%), 634 (84.8%) and 552 patients (73.8%) continued treatment until V1 (Month 3), V2 (Month 6), and V3 (Month 12/end of observation period), respectively.Efficacy analyses were performed on the mITT population which included 700 patients (RA=237, PsA=235, AS=228) who had at least 2 documented visits.The statistically significant improvements (all p-values <0.05) in the mean WPAI domain scores were maintained over the 12-month observation period in all 3 indications with a higher treatment effect regarding “activity impairment” and “presenteeism” than with “absenteeism”. The magnitude of improvements in the 4 WPAI domains and the time course of improvements varied between the underlying disease (RA, PsA, AS).In general, the improvements in the 4 WPAI domains were greater in patients with AS and PsA compared to RA patients. A continuous improvement over time was seen in AS patients regarding the domain “activity impairment. A positive effect of pre-treatment with biologics (i.e. better improvement in WPAI) was seen in RA patients for 3 domains (TWPI”, absenteeism, presenteeism), and in PsA patients for 2 domains (absenteeism, activity impairment).Conclusions:Golimumab s. c. 1 x monthly is an effective treatment in patients with RA, AS and PsA.All scores of the WPAI showed a significant (p<0.05) reduction in mean score values in each indication.Golimumab leads to an improvement of work...

This paper presents two case histories of patients receiving intravenous (IV) darbepoetin alfa for the treatment of anaemia in chronic renal failure. The paper sets these cases against the general clinical picture of patients receiving intravenous darbepoetin alfa in our renal unit.

BackgroundGolimumab (GLM) has shown its efficacy and tolerability in various randomized clinical trials. Systemic data for GLM regarding health-economic parameters in daily clinical practice are essential not only for pharmaceutical companies but also for cost-benefit analyses in Germany.ObjectivesThis prospective NIS was designed to evaluate the impact of GLM therapy on work productivity and activity as well as Quality of Life (QoL) in patients with RA, AS or PsA in Germany under routine settings over an observation period of 12 months, plus an additional voluntary extension period of 12 months (total 24 months) to collect long-term data on health economic parameters.MethodsGO-ART was an observational prospective study on patients with RA, AS or PsA (biologic-naïve and biologic-experienced) who started treatment with GLM at 63 sites of Germany.The primary endpoint was the change in work productivity/activity impairment as measured by Work Productivity and Activity Impairment (WPAI) questionnaire from baseline, measured primarily at month 3 and secondarily at months 6, 12 and 24.As secondary endpoint the change in quality of life (RAQoL for RA patients, ASQoL for AS patients and NAPPA-QoL for PsA patients) was assessed.Results748 patients (RA=250, PsA=249, AS=249) started GLM therapy.The primary efficacy endpoint was analyzed in the modified intention-to-treat (mITT) subset of 493 patients (RA=158, PsA=157, AS=178) with full-time or part-time employment at baseline (mITTe).A total of 348 patients entered the additional 12-month observation period, of which 303 completed the 24-month assessment.By 3 months after initiation of Golimumab treatment, a marked improvement was seen in all 4 WPAI domain scores (“absenteeism” (time off work), “presenteeism” (on-the-job productivity), “total work productivity impairment” (TWPI), and “activity impairment”) in daily living because of patient’s health problems related to RA, PsA or AS, as shown in Table 1 (all p-values <0.05).The statistically significant improvements in the mean WPAI domain scores were maintained over the 24-month observation period in all 3 indications with a higher treatment effect regarding “activity impairment” and “presenteeism” compared to “absenteeism” (Table 1).Quality of life improved significantly (p<0.0001) from baseline at month 3, 6, 12 and 24 in patients with RA (RAQoL), AS (ASQoL) and PsA (NAPPA-QoL) based on questionnaire data of 237 RA patients (RA-mITT), 228 AS patients (AS-mITT) and 235 PsA patients (PsA-mITT) indicating a clinically relevant improvement.ConclusionTreatment with GLM provided sustained improvement in WPAI and QoL in patients with RA, PsA and AS over the observational period of 24 months.All scores of the WPAI showed a significant (p< 0.05) reduction in mean score values in each indication.GLM leads to an improvement of work productivity and daily activities in patients already within the first 3 months of treatment.Disclosure of InterestsInes Klaudius Employee of: MSD Sharp & Dohme GmbH, Klaus Krueger: None declared, Sven Re...

BackgroundGolimumab (GLM) has demonstrated efficacy in RA, PsA, and AS in several randomized clinical trials with biologic-naïve patients. Data from real world practice comparing biologic naïve and experienced patients are lacking.ObjectivesThe aim of this post hoc analysis is to assess effectiveness of GLM used as first, second, or at least third biologic agent in RA, PsA and AS in a real-life setting.MethodsPost hoc analysis of the non-interventional, prospective, 24-month GO-NICE study with RA, PsA and AS patients (pts.) starting GLM 50mg SC once monthly in a real practice setting in Germany, details were shown earlier (1,2). Endpoint measures DAS28-ESR, PsARC, and BASDAI are shown as observed.ResultsIn 1458 pts. with RA, PsA or AS GLM was administered as first (n=305, 286, 292, resp.), second (n=104, 136, 130 resp.), or at least third biologic agent (n=64, 79, 58 resp.). Biologic argents in previous treatments included Adalimumab (348), Etanercept (287), Infliximab (139), Tocilizumab (27), Rituximab (15), Certolizumab (14), or Abatacept (n=12). 43.0, 30.8, 39.1% of pts. with RA, 53.1, 38.2, 34.2% with PsA, and 53.8, 49.2, 41.4% with AS completed the study until month 24.RA pts(n=473) RF was positive in 76.9%, 70.2%, and 59.4%, ACPA + in 76.2%, 78.4%, 59.0%, and disease duration was 9.7, 10.1, 14.3 years, in pts. with GLM use as 1st, 2nd, at least 3rd line respectively.DAS28 score at BL was 5.0, 4.9, 5.1 in first, second, and at least third line use of GLM, respectively and dropped significantly in all groups (table). After 3 months of treatment 27.5%, 19.5%, 14.5% of pts. were in remission (<2.6), after 24 months 45.3%, 50.0% or 33.3%, respectively.PsA pts(n=501) Disease duration was 12.4, 13.7, 13.8 yrs, in pts. with GLM use as 1st, 2nd, at least 3rd line respectively. PsARC response was achieved in 76.4%, 51.0% and 50.0% in first, second, and at least third line use of GLM, respectively at 24 months.AS pts(n=483) HLAB27-positive in 81.2%, 80.8%, and 74.1%, in pts. with GLM use as 1st, 2nd, at least 3rd line respectively. At BL 162 pts. had extra articular manifestations, most commonly iritis, enthesitis, IBD, and dactylitis (in 31.2%, 35.9%, and 43%, pts. respectively. Pts. with at least 2 previous bDMARDs had higher BASDAI at BL than pts. with GLM use in 1st or 2nd line: 5.7 vs. 5.0, and 4.9. After 24 months of treatment the mean BASDAI scores decreased significantly (p<0.001 vs. BL) to 2.1, 2.9, 2.9 in 1st, 2nd, and at least 3rd line use of GLM, respectively.Overall safety findings were comparable to those reported in controlled trials and no new safety signals were detected.RA DAS28-ESR1st line (bDMARD-naïve)2nd line 3rd line (at least)Month (mo) 0, BL mean DAS28 [SD] n=303n=104n=645.0 ± 1.34.9 ± 1.35.1 ± 1.5mo 24: mean DAS28 [SD] p vs. BLn=128 n=32 n=24 2.9 ±1.3 <.00012.9 ± 1.3 <.0001 3.4 ± 1.5 <.0001PsA PsARC1st line (bDMARD-naïve)2nd line 3rd line (at least)visit 1 mo 0, BLn=286n=136n=79mo 24:PsARC. response n (%)n=113 n=25 n=12 76.4%51.0%50.0%AS BASDAI1st line (bDMARD-naïve)2nd line 3rd line (at least...