Effectiveness of baricitinib and tofacitinib compared with bDMARDs in RA: results from a cohort study using nationwide Swedish register data

Abstract

Objectives To describe the use of baricitinib and tofacitinib by Swedish rheumatoid arthritis (RA) patients and to compare their effectiveness with that of biological disease-modifying anti-rheumatic drugs (bDMARDs). Methods RA patients who initiated baricitinib [N = 1420], tofacitinib [N = 316], abatacept [N = 1050], interleukin-6 inhibitors (IL6i) [N = 849], rituximab [N = 1101] or tumour necrosis factor inhibitors (TNFi) [N = 6036] between January 2017 and November 2019 were followed for minimum one year, using data from several linked Swedish national registers. Proportions reaching good-EULAR-DAS28 response, HAQ-DI improvement above 0.2 units and CDAI remission were compared at one year, imputing discontinued treatments as “non-response”. Additionally, we compared drug retention and changes in DAS28, HAQ-DI and CDAI from baseline to three months after treatment initiation. Results On average, baricitinib and particularly tofacitinib were initiated as later lines of therapy and more frequently as monotherapy compared with rituximab and TNFi. Adjusted one-year response proportions were consistently lower on TNFi compared with baricitinib, with differences of -4.3 percentage points (95% CI: -8.7–0.1) for good-EULAR response, -9.9 (-14.4 to -5.4) for HAQ-DI improvement, and -6.0 (-9.8 to -2.2) for CDAI remission. Comparisons with non-TNFi bDMARDs also favoured baricitinib, but not consistently. Treatment responses for tofacitinib were only marginally lower than those for baricitinib and generally similar to those of bDMARDs, with precision limited by low power. Comparisons of drug retention and changes in disease activity from baseline to three months supported the one-year findings. Conclusions Baricitinib and tofacitinib showed at least equivalent effectiveness compared with bDMARDs after exploring several different effectiveness measures.

Efficacy and drug persistence of baricitinib monotherapy is similar to combination therapy in patients with active RA: a prospective observational study

“…Our real-world prospective analysis shows a similar time course of disease activity using DAS28 ESR under BARI-mono and BARI-combo therapy with the BARI-combo group being numerically, but not statistically better throughout almost all time points, confirming data from a randomised controlled trial and Swedish Registry data, the latter comparing BARI mono with BARI combination with csDMARDs 5 14. Furthermore, we detected similar rates of drug survival between BARI-mono and BARI-combo which is of interest for patients who do not tolerate MTX.…”

“…Italian and Spanish multi-centre observational cohorts confirmed the efficacy and safety profile of BARI in bDMARD-naïve RA patients and revealed that drug survival is better in patients with seropositive RA 12 13. Analysis from a Swedish registry data revealed that BARI was equally effective compared with other bDMARDs and that BARI was more commonly used as monotherapy compared with rituximab and TNFi 14. These studies have analysed the efficacy of BARI mono versus BARI combination with overall csDMARDs but detailed observational data comparing BARI monotherapy to an explicit combination with MTX with respect to treatment response and drug survival were not reported.…”

“…Furthermore, long-term extension phases of these clinical trials demonstrated effectiveness and drug persistence for monotherapy as well as combination with MTX with slight benefits for combination therapy 5 7. Apart from the RA-BEYOND study results, there is to our knowledge no other published study to date comparing the efficacy of BARI as monotherapy versus combination therapy with MTX explicitly, while there are data available on combination with csDMARDs 13 14. Furthermore, no study from routine practice is available that compared BARI-mono versus BARI-combo therapy in a large cohort.…”

“… 12 13 Analysis from a Swedish registry data revealed that BARI was equally effective compared with other bDMARDs and that BARI was more commonly used as monotherapy compared with rituximab and TNFi. 14 These studies have analysed the efficacy of BARI mono versus BARI combination with overall csDMARDs but detailed observational data comparing BARI monotherapy to an explicit combination with MTX with respect to treatment response and drug survival were not reported. This situation stands in contrast to TNFi in RA, which are recommended in combination with MTX, as it has long been shown that MTX improves the overall response to and persistence with TNFi probably by preventing the development of anti-drug antibodies.…”

Safety of biological and targeted synthetic disease-modifying antirheumatic drugs for rheumatoid arthritis as used in clinical practice: results from the ARTIS programme

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