Treat-to-target in systemic lupus erythematosus: a pilot study

The treating-to-target (T2T) therapeutic strategy has been endorsed by experts
in systemic lupus erythematosus (SLE) but thus far it has not been properly
studied nor implemented. The field of health informatics has emerged as an
interdisciplinary science that could represent a way to facilitative clinical
decision support in the context of a T2T approach in SLE, providing a rapid
tool of computerized guidelines for an adequate therapy adjustment in order to
reach the treatment target efficiently. The computerized clinical decision
support systems, or CDSS, are e-health information systems designed to assist
clinicians and other health care professionals in clinical decision-making, and
can improve adherence to clinical guidelines.

The primary objectives of the study are as follow:
1) To assess usability and adherence to a T2T strategy implemented through a
digital e-health tool website (i.e. do physicians work through all aspects of
the website and take part in all the T2T process: target selection and
medication adjustments delivered by the e-health tool)
2) To assess acceptability of the T2T strategy implemented through a digital
e-health tool for the management of SLE patients (i.e. do patients and
physicians agree to the T2T approach and is it feasible to identify a treatment
target for each patient)
3) To assess the feasibility of recruitment including length of time required
to complete participant recruitment and retention rates (i.e. is it feasible to
recruit the number of participants required within the specified recruitment
time period, the proportion of patients that can/wishes to participate and the
proportion of *drop outs*)
4) To conduct a qualitative and quantitative process evaluation with
participants: patients and health care providers (HCP); to identify barriers
and enabling factors for completion of the study and its potential
reproducibility to larger T2T trials.

The secondary objectives are to estimate the variability in disease activity,
SLICC damage index, health related quality of life (HRQoL) and proportion of
disease flares apparition, by generating interval estimates of the mean
difference over time for each outcome measure. This will enable the statistical
power calculations for a subsequent larger scale evaluation to assess the
effectiveness of the T2T intervention as part of routine outpatient care.

A 24-weeks, non-randomized, cluster, multicentre, treat-to-target pilot study.

Patients will be grouped per treatment centre (cluster), where two out of the
four study centres will treat patients according to T2T, for which a target
will be defined by integrating all important aspects of the disease - clinical
state, measured by SLEDAI-2K and *clinical* SLEDAI-2K, Physician Global
Assessment (PGA), and current medication - through an input into the e-Health
tool, accompanied by the patient's wishes regarding her or his treatment. This
will allow to then generate the output defined as recommendations for regular
medication adjustments depending on the pre-defined target. This
recommendations can be implemented accordingly by a rheumatologist and/or a
nurse dedicated to SLE. In the two other centres, routine outpatient care will
be performed and will be evaluated as a control group where patients will be
treated following the regular standard of care according to the treating
physician*s judgment and criteria.

The burden associated with the study is minimal, and represented by extra
visits to the outpatient clinic by the patients in the T2T arm for target
achievement evaluation, plus extra physical examinations or other test as
required. Patients and physicians will be also asked to complete several
questionnaire before, during and near the end of the study on the
acceptability of the overall T2T strategy implementation and the usability of
the digital e-health tool for the management of SLE patients. There is no
direct risk associated to the study since no investigational treatment product
is involve. Patients have no direct benefit from participating in this study,
since their regular clinical assessment and treatment is not dependent on their
participation. Patients on the T2T arm will participate actively in the
decision making process regarding the treatment strategy.