110
Application of the Concept of Personalized Medicine
in Rheumatoid Arthritis
The healthcare services worldwide are now both looking at the use of personalized
medicine to provide better care. One of the fi rst applications of personalized medi-
cine was for breast cancer [ 31 ], where identifi cation of molecular targets inside the
tumor tissue is now mandatory for the use of targeted treatments. This practice has
reached the regulatory level and drug trials are ongoing based on targeted biomark-
ers. Some of these aspects can be applied to RA. A tailored approach to treatment can
be envisioned, based, for example, on combinations of biologics or sequential thera-
pies guided by biomarkers. Maintaining a clinical balance between applying timely
and effective treatment and avoiding ineffective, costly, and potentially aggressive
treatment at the personal level is at present one of the main challenges in RA man-
agement. Unfortunately, the optimal tools for diagnosis, prognosis, treatment selec-
tion, and effi cacy measurement are not yet at hand. The search for biomarkers
identifying key targets for the assessment of major outcomes in rheumatoid arthritis
became a hot issue over the past few years. The National Institutes of Health bio-
markers defi nition working group [ 73 ] defi nes a biomarker as “a characteristic that
is objectively measured and evaluated as an indicator of normal biological processes,
pathogenic processes, or pharmacologic responses to a therapeutic intervention.”
Patient-Reported Outcome Measures as a Biomarker
in Rheumatoid Arthritis
In RA, which is a major leading cause of disability, proposed biomarkers should
help the identifi cation of the patients suffering from persistent infl ammatory arthri-
tis in its early stages. Biomarkers also should help to identify those who would
require aggressive forms of therapy (whether through a combination of disease-
modifying antirheumatic drugs [DMARDs] or early biologic therapy), and show
variation with the disease activity with the possibility of adopting patient-centered
care into standard clinical practice. Biomarkers should also be able to identify those
patients prone to sustaining structural joint damage early in the disease course. The
possibility of identifying the individual RA patient’s future disease severity could
guide the choice of the best treatment strategy and during the disease course could
help in tailoring a treatment plan aiming at stopping the joint damage.
Change from baseline for patient-reported outcomes was assessed in four treat-
to- target studies (Table 4.3 ) [ 74 – 77 ]. Recent studies [ 22 , 78 ] assessed biomarkers
and a patient-tailored approach in rheumatoid arthritis and whether PROMs are the
missing biomarkers. Changes from baseline to week 76 of clinical variables,
patient- reported outcome measures, and measures of radiographic progression were
assessed in 481 subjects suffering from early infl ammatory arthritis (disease dura-
tion <6 months) diagnosed according to the ACR/EULAR criteria 2010 and treated
Y. El Miedany