BSRBR|Newsletter - The British Society for Rheumatology

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BSRBR|Newsletter Presentation of latest results: ACR, Philadelphia, October 2009 We have had two new analyses accepted for oral presentation at the ACR in Philadelphia this year and one poster: Wednesday 21st October 11 – 12:30pm Session: RA Clinical Aspects Treatment Outcomes Presentation 1: The influence of anti-TNF therapy upon incidence of non-melanoma skin cancer (NMSC) in patients with rheumatoid arthritis (RA): Results from the BSR Biologics Register (BSRBR) Presentation 2: Risk of septic arthritis in patients with rheumatoid arthritis treated with anti-TNF therapy: results from the BSR Biologics Register (BSRBR) Tuesday 20th October Poster: Serious infections in patients with Rheumatoid Arthritis (RA) treated with anakinra (ANA): Experience from the BSR Biologics Register (BSRBR) Web-based data collection We are starting to plan for a web-based data collection system for those of you who would prefer to enter data directly onto a website (for submission to the Register database) rather than completing and sending paper-based questionnaires. Our aim is to create the web entry forms in such a way that: • it is quicker for you to complete them than filling in paper forms (use of drop-down lists etc) • data is checked as entered, thus reducing need to correct errors by the team at Manchester. We will soon be sending a short survey to those of you responsible for sending data, to find out how easy you would find it to switch to electronic data entry. We also hope to identify some sites willing to be the “guinea pigs” for this new system. If you are interested in discussing this, please contact Kath Watson at kath.watson@manchester.ac.uk or Nia Taylor at ntaylor@rheumatology.org.uk. Recent Publications For a full list of BSRBR publications list please visit the “Health Professionals” area of our website (www.manchester.ac.uk/medicine/arc/BSRBR) and click on “Publications”. Saad AA, Ashcroft DM, Watson KD, Hyrich KL, Noyce PR, Symmons DP; British Society for Rheumatology Biologics Register. Persistence with anti-tumour necrosis factor therapies in patients with psoriatic arthritis: observational study from the British Society for Rheumatology Biologics Register. Arthritis Res Ther. 2009; 11(2):R52. Epub 2009 Apr 8. Harrison MJ, Dixon WG, Watson KD, King Y, Groves R, BSRBR Control Centre Consortium, Hyrich KL, Symmons DP on behalf of the BSRBR. Rates of new-onset psoriasis in patients with rheumatoid arthritis receiving anti-tumour necrosis factor alpha therapy: results from the BSRBR. Ann Rheum Dis. 2009 Feb; 68(2):209-15. Lunt M, Solomon D, Rothman K, Glynn R, Hyrich K, The BSRBR Control Centre Consortium, BSRBR, Symmons DP, Stürmer T. Different Methods of Balancing Covariates Leading to Different Effect Estimates in the Presence of Effect Modification. Am J Epidem. 2009 Jan 19. [Epub ahead of print] Hyrich KL, Lunt. M, Dixon WG, Watson KD, Symmons. DPM, BSRBR. Effects of switching between anti-TNF therapies on HAQ response in patients who do not respond to their first anti-TNF drug. Results from the national British Society for Rheumatology Biologics Register (BSRBR). Rheumatology (Oxford). 2008 Jul; 47(7):1000-5. Hyrich KL, Watson KD, Isenberg DA, Symmons DP. The British Society for Rheumatology Biologics Register: 6 years on. Rheumatology (Oxford). 2008 Oct; 47(10):1441-3. All BSRBR follow-up extended to 2013 As already mentioned, we have extended the follow-up of all patients in the BSRBR to 2013. This means that annual follow-ups will be sent out after five years of follow-up asking about any changes in therapy and any serious adverse events that have occurred in the past year. Therefore we are only interested in those events that fulfil our definition of serious and those non serious adverse events that led to discontinuation of a drug (see table). Website suggestions? Please send suggestions for improvements/information you would like to be able to access on the BSRBR website to pat.creighton@manchester.ac.uk. Definition of serious adverse events 1. Death 2. Hospitalisation 3. IV antibiotics 4. Significant loss of function 5. Congenital malformation 6. Life threatening Please also record all events that led to a drug discontinuation. 6
BSRBR|Newsletter www.rheumatology.org.uk Events of Special Interest forms reminder We urge you to download our new “Events of Special Interest” forms from our website www.manchester.ac.uk/medicine/arc/BSRBR under the “Health Professionals” section. This is so you can complete these forms at the same time as you initially report one of these events to us on the follow-up form. This means that we will not have to bother you for more information on the event at a later date and will save you having to access the case notes again. The following events are those for which we need to have one of these forms completed: • Aplastic anaemia • Central demyelination • Congestive heart failure • Infusion/immunologic reactions (rituximab only) • Lymphoproliferative tumour • Myocardial infarction • Pregnancy • Pulmonary embolism • Serious infections • Stroke • Surgery • Tuberculosis If not received with the follow-up form, we will post the form out to you to enable us to collect this information. BSRBR Events of Special Interest Forms NICE update Multiple Technology Appraisals Rheumatoid arthritis – drugs for treatment after failure of a TNF inhibitor BSR submitted evidence on 10 August 2009 based on the final scope of this appraisal. The submission consisted of two papers: one from the arc epidemiology unit at Manchester with the latest evidence from the Biologics Register and one from the BSR Clinical Affairs Committee based on the revised BSR Biologics Guidelines. The appraisal was re-started in November 2008, following the NICE Appeal Committee’s recommendation that NICE reconsider the issue of allowing patients prescription of an alternative anti-TNF if their first anti-TNF does not work satisfactorily. The first appraisal committee meeting will take place on 4 February 2010. Psoriatic arthritis - etanercept, infliximab and adalimumab (review) BSR submitted comments on the final scope on 26 August 2009. Single Technology Appraisals Abatacept - Juvenile idiopathic arthritis NICE informed us that this technology appraisal had been suspended, as the manufacturer of Abatacept was not in a position to submit evidence due to a delay in the regulatory process. We will keep you updated on any developments. Certolizumab BSR submitted an organisational statement for this appraisal in June 2009. The first appraisal committee meeting took place on 23 September 2009, with the guidance expected to be issued in February 2010. Golimumab The three appraisals on Golimumab (for the treatment of rheumatoid arthritis after failure of previous antirheumatic drugs, for the treatment of rheumatoid arthritis (methotrexate-naïve) and for the treatment of ankylosing spondylitis) have all been suspended at the request of the manufacturer, as they were not in a position to submit evidence. We will keep you updated on any developments. Tocilizumab NICE Appraisal Committee’s preliminary recommendation (1st October) is that Tocilizumab is not recommended for the treatment of moderate to severe active rheumatoid arthritis. These recommendations are under consultation and the deadline for comments is 22nd October 2009. Clinical guideline updates Tuberculosis - update of clinical guidelines BSR is participating in the revision of these guidelines, and took part in the stakeholder workshop held on 29 September 2009. 7
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