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100 Publications visible to you, out of a total of 100
[Safety of biologic therapy - results from the German biologics register RABBIT]

Abstract

Not specified

Authors: A. Strangfeld, A. Zink

Date Published: 2014

Publication Type: Journal

Evaluation of the RABBIT Risk Score for serious infections

Abstract (Expand)

OBJECTIVE: To evaluate the Rheumatoid Arthritis Observation of Biologic Therapy (RABBIT) Risk Score for serious infections in patients with rheumatoid arthritis (RA). METHODS: The RABBIT Risk Score for … serious infections was developed in 2011 on a cohort of RA patients enrolled in the German biologics register RABBIT between 2001 and 2007. To evaluate this score, we used data from patients enrolled in RABBIT after 1 January 2009. Expected numbers of serious infections and expected numbers of patients with at least one serious infection per year were calculated by means of the RABBIT Risk Score and compared with observed numbers in the evaluation sample. RESULTS: The evaluation of the score in an independent cohort of 1522 RA patients treated with tumour necrosis factor alpha (TNFalpha) inhibitors and 1468 patients treated with non-biological disease-modifying antirheumatic drugs (DMARDs) showed excellent agreement between observed and expected rates of serious infections. For patients exposed to TNF inhibitors, expected as well as observed numbers of serious infections were 3.0 per 100 patient-years (PY). For patients on non-biological DMARDs the expected and observed numbers were 1.5/100 PY and 1.8/100 PY, respectively. The score was highly predictive in groups of patients with low as well as with high infection risk. CONCLUSIONS: The RABBIT Risk Score is a reliable instrument which determines the risk of serious infection in individual patients based on clinical and treatment information. It helps the rheumatologist to balance benefits and risks of treatment, to avoid high-risk treatment combinations and thus to make informed clinical decisions.

Authors: A. Zink, B. Manger, J. Kaufmann, C. Eisterhues, A. Krause, J. Listing, A. Strangfeld

Date Published: 2014

Publication Type: Journal

Current state of evidence on ’off-label’ therapeutic options for systemic lupus erythematosus, including biological immunosuppressive agents, in Germany, Austria and Switzerland–a consensus report

Abstract (Expand)

Systemic lupus erythematosus (SLE) can be a severe and potentially life-threatening disease that often represents a therapeutic challenge because of its heterogeneous organ manifestations. Only … glucocorticoids, chloroquine and hydroxychloroquine, azathioprine, cyclophosphamide and very recently belimumab have been approved for SLE therapy in Germany, Austria and Switzerland. Dependence on glucocorticoids and resistance to the approved therapeutic agents, as well as substantial toxicity, are frequent. Therefore, treatment considerations will include ’off-label’ use of medication approved for other indications. In this consensus approach, an effort has been undertaken to delineate the limits of the current evidence on therapeutic options for SLE organ disease, and to agree on common practice. This has been based on the best available evidence obtained by a rigorous literature review and the authors’ own experience with available drugs derived under very similar health care conditions. Preparation of this consensus document included an initial meeting to agree upon the core agenda, a systematic literature review with subsequent formulation of a consensus and determination of the evidence level followed by collecting the level of agreement from the panel members. In addition to overarching principles, the panel have focused on the treatment of major SLE organ manifestations (lupus nephritis, arthritis, lung disease, neuropsychiatric and haematological manifestations, antiphospholipid syndrome and serositis). This consensus report is intended to support clinicians involved in the care of patients with difficult courses of SLE not responding to standard therapies by providing up-to-date information on the best available evidence.

Authors: M. Aringer, H. Burkhardt, G. R. Burmester, R. Fischer-Betz, M. Fleck, W. Graninger, F. Hiepe, A. M. Jacobi, I. Kotter, H. J. Lakomek, H. M. Lorenz, B. Manger, G. Schett, R. E. Schmidt, M. Schneider, H. Schulze-Koops, J. S. Smolen, C. Specker, T. Stoll, A. Strangfeld, H. P. Tony, P. M. Villiger, R. Voll, T. Witte, T. Dorner

Date Published: 2012

Publication Type: Journal

How well do patient reports reflect adverse drug reactions reported by rheumatologists? Agreement of physician- and patient-reported adverse events in patients with rheumatoid arthritis observed in the German biologics register

Abstract (Expand)

OBJECTIVE: To analyse the validity of patient reports on adverse drug reactions (ADRs) compared with the reports given by the treating physician. METHODS: Patients with RA enrolled in the German biologics … register rheumatoid arthritis observation of biologic therapy (RABBIT) between May 2001 and September 2006 were included in the study. We investigated concordance of reporting and level of agreement between physician- and patient-reported ADRs, taking the physician as gold standard. RESULTS: Data from 4246 patients were analysed. Patients reported on average 1.2 ADRs per patient-year (PY) compared with 0.8 ADRs reported by the physicians (P<0.001). Gastrointestinal disorders were the most frequently reported ADRs by patients (277.8/1000 PYs) and physicians (137.8/1000 PYs), infections were reported with considerably higher frequency by physicians (124/1000 PYs) than by patients (72/1000 PYs). Agreement between patients and physicians (same or similar event reported at the same time) differed according to the nature of the reported ADR. High agreement was found for easily observable, known ADRs (such as alopecia, agreement 76.7%) In contrast, even for some serious ADRs, many patients did not see a connection between the event and the drug taken (e.g. pneumonia, agreement 37.7%). CONCLUSIONS: Patient reports on ADRs are a useful source of information on the safety of new therapies. However, drug surveillance cannot rely on patient reports only, since even life-threatening events were not reported as ADRs by the patients who failed to associate them with the therapy. When coding patient reports on ADRs to a standard coding system, the differences in language and terminology between patients and physicians should be taken into account.

Authors: L. Gawert, F. Hierse, A. Zink, A. Strangfeld

Date Published: 2011

Publication Type: Journal

Treatment benefit or survival of the fittest: what drives the time-dependent decrease in serious infection rates under TNF inhibition and what does this imply for the individual patient?

Abstract (Expand)

OBJECTIVE: To examine the risk of serious infection conveyed by tumour necrosis factor alpha (TNFalpha) inhibitors in the treatment of rheumatoid arthritis (RA). METHODS: Data from patients with RA … enrolled in the German biologics register RABBIT were used for analysis. Baseline patient characteristics, time-varying risk factors (treatment changes, functional capacity) and selection processes caused by dropout, death or switching to non-anti-TNF treatment were taken into account to estimate the adjusted incidence rate ratios (IRR(adj)) of serious infection during treatment with TNF inhibitors compared with non-biological disease-modifying antirheumatic drug treatment. RESULTS: Data were available on 5044 patients, in whom 392 serious infections occurred. The crude rates of serious infections in patients treated with TNF inhibitors declined over the first 3 years of observation (from 4.8 to 2.2/100 patient-years). This decline was driven by (1) treatment termination or loss to follow-up in patients at increased risk and (2) a risk reduction through decreasing glucocorticoid doses and improvement in function. Adjusted for selection processes and time-varying risk factors, the following parameters assessed at baseline (age, chronic diseases) or at follow-up prior to the infection were significantly associated with an increased risk: age >60 years, chronic lung or renal disease, low functional capacity, history of serious infections, treatment with glucocorticoids (7.5-14 mg/day, IRR(adj) 2.1 (95% CI 1.4 to 3.2); >/= 15 mg/day, IRR(adj) 4.7 (95% CI 2.4 to 9.4)) and treatment with TNFalpha inhibitors (IRR(adj) 1.8 (95% CI 1.2 to 2.7)). CONCLUSION: Reasons for the decline in infection rates observed at the group level were identified. The results enable expected infection rates to be calculated in individual patients based on their risk profiles.

Authors: A. Strangfeld, M. Eveslage, M. Schneider, H. J. Bergerhausen, T. Klopsch, A. Zink, J. Listing

Date Published: 2011

Publication Type: Journal

Detection and evaluation of a drug safety signal concerning pancreatic cancer: lessons from a joint approach of three European biologics registers

Abstract (Expand)

OBJECTIVES: A high incidence of pancreatic cancer (PCa) in patients exposed to was observed in the German biologics register. To evaluate this possible safety signal, a concerted analysis with the … national biologics registers in the UK and Sweden was performed. METHODS: Patients with enrolled in the British Society of Rheumatology Biologics Register (BSRBR), the Swedish Rheumatology Register (SRR) or the German Biologics Register [Rheumatoid Arthritis Observation of Biologic Therapy (RABBIT)] were analysed. The patients were exposed to biologic or conventional DMARDs. Outcomes were obtained from physician reports, health authorities and via linkage to national cancer and death registers. Age- and gender-standardized incidence ratios (SIRs) of PCa were calculated based on the expected rates available from the individual national cancer registers. RESULTS: Data from 5126 (Germany), 16 930 (UK) and 19 351 (Sweden) RA patients were available for the analysis. The highly discrepant prescription rates of LEF in the respective countries resulted in 11 343 (Germany), 30 787 (UK) and 2518 (S) patient-years of exposure to LEF. Compared with the general population, the incidence of PCa in patients ever exposed to LEF corresponded to a SIR of 3.1 (95% CI 1.3, 6.5) in Germany, 1.05 (95% CI 0.5, 2.1) in the UK and 1.8 (95% CI 0.1, 10.2) in Sweden. CONCLUSION: The results of the replication analyses do not support the hypothesis of an increased risk of PCa in patients exposed to treatment with LEF. However, they do not completely rule out concerns, and therefore further verification in other data sets is recommended.

Authors: A. Strangfeld, K. Hyrich, J. Askling, E. Arkema, R. Davies, J. Listing, M. Neovius, J. Simard, D. Symmons, K. Watson, A. Zink

Date Published: 2011

Publication Type: Journal

[The importance of patient perspective in drug surveillance systems]

Abstract (Expand)

AIMS: using data from the German biologics register RABBIT we investigated which gain in information can be achieved by integrating patient-reported adverse drug reactions (ADRs) into drug surveillance … systems. METHODS: patients with rheumatoid arthritis enrolled in the longitudinal cohort of the German biologics register between May 2001 and September 2006 who had undergone at least one follow-up were included in the study. All ADRs reported to the register either by the treating rheumatologists or the patients were coded with the same coding system (MedDRA(R)). The agreement between patients and physicians was analysed for the most frequently reported ADRs using the patient as gold standard. RESULTS: data from 4246 patients with a mean observation time of 2 years were analysed. Patients reported on average 1.2 ADRs per patient year (PY), while physicians indicated 1 ADR per PY (p<0,001). The ADR most frequently reported by patients was nausea (93.8 per 1000 PY), followed by fatigue (72.5 per 1000 PYs) and alopecia (60.6 per 1000 PYs). These ADRs were significantly less often reported by physicians. Agreement between patients and physicians was higher in more objective symptoms, such as injection site reaction (in 60.0% of cases where the patient reported this symptom, the physician did so too) or rash (53.0%), than in more subjective symptoms such as fatigue (17.4%). Agreement was highest in life-threatening events. CONCLUSIONS: patients report a higher number of ADRs than their treating physicians. Patients report subjective symptoms impacting on quality of life more frequently than physicians. Patient-physician agreement on known or clinically relevant ARDs is high. Integration of patient reports on ADRs into clinical routine could enhance the patient-physician partnership and improve compliance as well as awareness of signs and symptoms of possible ADRs.

Authors: L. Gawert, F. Hierse, A. Zink, A. Strangfeld

Date Published: 2010

Publication Type: Journal

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