Comparable Long-term Safety of Tofacitinib and Biologics in RA Treatment – Data from a US Registry
An analysis of the long-term safety profile of tofacitinib in real clinical practice was published in the journal of the American College of Rheumatology (ACR). Patients with rheumatoid arthritis (RA) who started treatment with tofacitinib showed a similar frequency of predefined adverse events of special interest compared to a cohort treated with biological disease-modifying antirheumatic drugs (bDMARDs).
Evaluation of Tofacitinib in Real Clinical Practice
Tofacitinib is a Janus kinase inhibitor whose efficacy in treating RA has been demonstrated in numerous clinical trials and their extension phases with follow-up periods up to 9.5 years. These results are now supplemented by an analysis of data from the Corrona registry, which collects data on RA patients through 177 private or academic centers in the USA. In 2018, the database contained data on 50,605 patients.
Analysis Methodology
The authors compared the incidence rate (IR) of adverse events (AEs) between patients who started treatment with tofacitinib and those who started treatment with bDMARDs between November 6, 2012, and July 31, 2018, regardless of dosage. The IR was calculated as the number of first occurrences of a given AE per 100 patient-years.
Adverse events of special interest included major adverse cardiovascular events (MACE), serious infections, herpes zoster (HZ) infections, malignancies, and deaths. The hazard ratios (HR) were estimated using a multivariable-adjusted Cox regression model.
Patients Monitored
The analysis of MACE and infections included 1,999 patients who started treatment with tofacitinib and 8,357 who started treatment with bDMARDs (adalimumab, certolizumab, golimumab, etanercept, infliximab, abatacept, anakinra, rituximab, or tocilizumab; it may not have been the first line of treatment). For the comparison of malignancy and mortality incidence, the cohort consisted of 1,999 patients who started treatment with tofacitinib and 6,354 who started treatment with bDMARDs. The analyzed sample included 732 patients treated with both tofacitinib and one or more bDMARDs.
Results
The incidence rate of AEs was similar between the cohorts (see table), except for HZ infections, which were significantly more frequent in the tofacitinib group (HR 2.32; 95% confidence interval [CI] 1.43−3.75).
Table. Incidence of Adverse Events of Special Interest
|
tofacitinib |
bDMARDs |
p-value |
|
|
IR (95% CI) |
IR (95% CI) |
(for adjusted HR) |
|
|
MACE |
0.64 (0.39−1.00) |
0.91 (0.74−1.09) |
0.081 |
|
serious infections |
3.12 (2.51−3.84) |
2.83 (2.54−3.15) |
0.943 |
|
HZ |
1.44 (1.03−1.94) |
0.65 (0.52−0.81) |
0.001 |
|
malignancies (excluding NMSC*) |
0.88 (0.58−1.27) |
0.81 (0.66−0.98) |
0.847 |
|
NMSC |
1.08 (0.75−1.51) |
1.10 (0.92−1.30) |
0.917 |
|
deaths |
0.84 (0.55−1.23) |
0.86 (0.71−1.04) |
0.688 |
Note: * NMSC – non-melanoma skin cancer
Conclusion
The analysis of data from a US patient registry showed that the safety profile of tofacitinib in RA treatment is comparable to that of bDMARDs, with the exception of HZ infections, which were more frequent in patients on tofacitinib.
(este)
Source: Kremer J. M., Bingham C. O., Cappelli L. C. et al. Postapproval comparative safety study of tofacitinib and biological disease-modifying antirheumatic drugs: 5-year results from a United States-based rheumatoid arthritis registry. ACR Open Rheumatol 2021; 3 (3): 173−184, doi: 10.1002/acr2.11232.
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