An evaluation of non-melanoma skin cancer and melanoma skin cancer rates among patients treated for moderately to severely active rheumatoid arthritis with Xeljanz® (tofacitinib citrate): A retrospective non-interventional database study of observational data embedded within Optimising Patient outcome in Australian RheumatoLogy - Quality Use of Medicines Initiative (OPAL-QUMI) (Skin cancer rates in OpaL - SOL study)

Study identification

• EU PAS number:
  EUPAS18431
• Study ID:
  40879
• Official title and acronym:
  An evaluation of non-melanoma skin cancer and melanoma skin cancer rates among patients treated for moderately to severely active rheumatoid arthritis with Xeljanz® (tofacitinib citrate): A retrospective non-interventional database study of observational data embedded within Optimising Patient outcome in Australian RheumatoLogy - Quality Use of Medicines Initiative (OPAL-QUMI) (Skin cancer rates in OpaL - SOL study)
• DARWIN EU® study:
  No
• Study countries:
  Australia
• Study description:
  Xeljanz® (tofacitinib citrate) is a potent, selective inhibitor of the Janus kinase (JAK) family of kinases with a high degree of selectivity against other kinases in the human genome. It was approved for use in Australia Feb 2015 and PBS listed (reimbursement) in Oct 2015. Being the first oral JAK inhibitor for the treatment of moderate to severe RA, there is a need to gather emerging real-world long-term safety data. These data will help to further contextualise and expand knowledge about the benefit:risk profile of Xeljanz in RA. To permit assessment of NMSC and MSC rates among RA patients being treated with Xeljanz in the post-approval setting, Pfizer will support a database study utilising data collected within the Optimising Patient outcome in Australian RheumatoLogy (OPAL) network, a clinician driven point of care observational data management consortium. The OPAL network is made up of Australian private-practice rheumatologists who agree to share a clinical record system for data gathering. Several studies have already been published based on data collected from this combined cohort. This protocol outlines operational and analytical aspects of a database study within the OPAL network to describe rates of NMSC and MSC among patients with RA treated with Xeljanz, stratified by patient demographics and clinical characteristics. The analyses will be based on enrolled incident users of Xeljanz for RA treatment. Similar data will also be collected for patients treated with biologic disease-modifying anti-rheumatic drugs (bDMARDs) to provide context about rates and types of NMSC/MSC in real-world Australian clinical practice. This study does not aim to perform formal comparisons between Xeljanz and bDMARDs.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pfizer

Networks

OPAL-QUMI

Study timelines

Date when funding contract was signed

Planned: 20/04/2016

Actual: 20/04/2016

Study start date

Planned: 19/05/2017

Actual: 09/05/2017

Data analysis start date

Planned: 19/05/2017

Actual: 09/05/2017

Date of final study report

Planned: 30/05/2022

Actual: 10/12/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable