Table 7. Recommendations for High-Risk Patients with
Established RA with Moderate or High Disease
Activity and Comorbidities (cont'd)
High-risk
Condition Recommendations
Level of
Evidence
Hepatitis C
c
Hepatitis C infection and
receiving/received effective
antiviral treatment
Same recommendations as in patients without
this condition.
Very Low
Hepatitis C infection and
not receiving or requiring
effective antiviral
treatment
Use DMARDs
d
over TNFi.
Very Low
Past history of treated or untreated malignancy
e
Previously treated or
untreated skin cancer
(non-melanoma or
melanoma)
Use DMARDs over biologics in melanoma.
Use DMARDs over tofacitinib in melanoma.
Use DMARDs over biologics in non-melanoma.
Use DMARDs over tofacitinib in non-melanoma.
Very Low
Previously treated
lymphoproliferative
disorder
Use rituximab over TNFi Very Low
Previously treated
lymphoproliferative
disorder
Use combination DMARD or abatacept or
tocilizumab over TNFi.
Very Low
Previously treated solid
organ malignancy
Same recommendations as in patients without
this condition.
Very Low
Previous serious infection(s)
f
Previous serious
infection(s)
Use combination DMARD over TNFi.
f
Use abatacept over TNFi.
g
Very Low
See Table 9 for explanation of the Green and bolded and Yellow and italicized recommendations.
a
Conditional recommendations supported by evidence level ranging from moderate level to no
evidence, supported by clinical experience and FDA safety warning with TNFi.
b
No studies were available, leading to very low quality evidence, and the recommendation was based
on clinical experience.
c
Strong recommendations for Hepatitis B were largely based upon the recent American Association
for the Study of Liver Diseases (AASLD) practice guidelines and clinical experience; conditional
recommendations for Hepatitis C were largely supported by very low level evidence based upon case
series and clinical experience.
d
Consider using DMARDs other than methotrexate or leflunomide, such as sulfasalazine or
hydroxychloroquine.
e
Conditional recommendations supported by level of evidence ranging from very low to no evidence
are largely based upon expert opinion and clinical experience.
f
Conditional recommendation was supported by very low level evidence.
g
ere was no consensus for making recommendations regarding the use of rituximab over TNFi or
the use of tocilizumab over TNFi in this setting, due to indirect evidence (e.g., no comparison to
TNFi or including patients with TB) and differences of opinion. In one study, compared to patients
who restarted their previous TNFi following hospitalized infections, patients who switched to
abatacept exhibited lower risk of subsequent hospitalized infections among the therapies examined.
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