The protocols for An Australian Specific Registry It is recommended the ongoing registry study for patients diagnosed with that the Sponsor studies have not RA, PsA and AxSpA is already report on both the been reviewed as established in Australia. The ARAD and DANBIO part of this registry is known as the studies within the evaluation. Should Australian Rheumatology PSUR. this application be Association Database (ARAD). It is also important approved it is ARAD is a national Australian to note that the recommended that database, which is supported by Sponsor makes the the sponsor the Australian Rheumatology following statement consider completing Association, and which collects regarding the an Australian important health information DANBIO registry Specific Registry from individuals with within the EU-RMP study including inflammatory arthritis including page 22: is “DANBIO patients diagnosed rheumatoid arthritis, ankylosing not a safety registry with RA, PsA and spondylitis and psoriatic arthritis. and does not look for AxSpA. The aim of ARAD is to determine specific adverse the short and long term events. All adverse effectiveness and safety of new events are received biological drugs, including as spontaneous certolizumab pegol, used to treat adverse events”. inflammatory arthritis conditions. The registry captures information on patient’s anti-rheumatic medications, including reasons for stopping or switching, current symptoms, and suspected adverse effects. Information about intercurrent infections, new comorbidities including malignancy, joint surgery, and hospitalizations, are also collected. Patients and rheumatologists across Australia contribute to ARAD. In addition, registries exist in the EU with a much larger cohort of patients. Examples of these specific registries include DANBIO. The sponsor should Medication This is acceptable. justify why the Potential medication errors are It is important to important missing note that the listed as missing information for information of Cimzia in the UCB Risk Sponsor discusses for “Potential Management Plan (RMP). the risk of medication errors” Medication error refers to any medication error will not be further unintentional error in the within the EU-RMP elucidated via prescribing, dispensing, or and makes the additional administration of a medicinal following statement pharmacovigilance. product while in the control of the regarding the importance of additional risk
The protocols for the ongoing registry studies have not been reviewed as part of this evaluation. Should this application be approved it is recommended that the sponsor consider completing an Australian Specific Registry study including patients diagnosed with RA, PsA and AxSpA. An Australian Specific Registry study for patients diagnosed with RA, PsA and AxSpA is already established in Australia. The registry is known as the Australian Rheumatology Association Database (ARAD). ARAD is a national Australian database, which is supported by the Australian Rheumatology Association, and which collects important health information from individuals with inflammatory arthritis including rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. The aim of ARAD is to determine the short and long term effectiveness and safety of new biological drugs, including certolizumab pegol, used to treat inflammatory arthritis conditions. The registry captures information on patient’s anti-rheumatic medications, including reasons for stopping or switching, current symptoms, and suspected adverse effects. Information about intercurrent infections, new comorbidities including malignancy, joint surgery, and hospitalizations, are also collected. Patients and rheumatologists across Australia contribute to ARAD. In addition, registries exist in the EU with a much larger cohort of patients. Examples of these specific registries include DANBIO. It is recommended that the Sponsor report on both the ARAD and DANBIO studies within the PSUR. It is also important to note that the Sponsor makes the following statement regarding the DANBIO registry within the EU-RMP page 22: “DANBIO is not a safety registry and does not look for specific adverse events. All adverse events are received as spontaneous adverse events”. The sponsor should justify why the important missing information of “Potential for medication errors” will not be further elucidated via additional pharmacovigilance. Medication Potential medication errors are listed as missing information for Cimzia in the UCB Risk Management Plan (RMP). Medication error refers to any unintentional error in the prescribing, dispensing, or administration of a medicinal product while in the control of the This is acceptable. It is important to note that the Sponsor discusses the risk of medication error within the EU-RMP and makes the following statement regarding the importance of additional risk
auspar-certolizumab-140815.docx