Table 2 Position statements
Issue | Statement | PRP agreement (%) (n = 9) | Physician agreement (%) (n = 161) |
|---|---|---|---|
Biosimilars | Biosimilars must be approved through a robust regulatory review. ‘Biomimics’ or’intended copies’ are not biosimilars. This may require ongoing education for both patients’ and clinicians’ education to ensure a thorough understanding Periodic re-evaluation of biosimilar products after their initial approval would be important to ensure ongoing quality Extrapolation to PsA, even when no studies of a given biosimilar were conducted in PsA, is acceptable. Ideally, additional studies specifically in PsA can be conducted if they were not part of the initial approval process Patients and clinicians must be involved in decisions about switching Pharmacovigilance is crucial; naming conventions need to allow tracking of specific agents and batches Multiple switches need to be studied in a rigorous fashion on an ongoing basis Savings realized from the use of biosimilars should be utilized to improve access for larger numbers of patients Immunogenicity is a potential concern that should be monitored on an ongoing basis | 85.7 | 92.5 |
Tapering | For patients who achieve the goals of therapy (for example, ideally remission, or low disease activity if remission is not achievable), tapering and ultimately discontinuing therapy may be considered Potential benefits of tapering may include lower risks of adverse effects as well as pharmacoeconomic benefits The decision to taper therapy should be made with the patients’ thorough understanding and direct involvement Discussions between patient and clinician should inform the optimal approach to tapering for each individual (for example, decreasing dosages, increasing treatment intervals, appropriate time intervals for making changes) Patients and clinicians need to understand that the potential drawbacks of tapering include: Reactivation of disease activity, with the possibility that re-achievement of the target may not be immediate and may not always be achieved At present it is not possible to predict a priori which patients might be able to successfully taper, which patients may be able to come off all medications and which patients will not be able to taper at all Although focused on active domains such as peripheral arthritis, it is not known how tapering of effective therapy might influence other outcomes, such as the increased risk of cardiovascular disease presumably related to systemic inflammation | 71.4 | 91.9 |
