Abstract | OBJECTIVE: METHOD: Adult RA, PsA, axSpA, JIA patients treated with ADA for at least 6 months, switched to SB5 in stable clinical conditions, were eligible. Data on safety, activity indexes and patient-reported outcomes were collected at baseline, 3 and 6 months after switching. RESULTS: Eighty-two patients (19 RA, 28 PsA, 32 axSpA and 3 JIA; 45 females, mean age 54 ± 14 years, disease duration 13 ± 7 years, ADA duration 6 ± 3 years) were enrolled. RA patients showed stable conditions, while PsA patients showed an increase in both HAQ, DAS28(CRP) and DAPSA and axSpA patients an increase in VAS pain, VAS patient disease activity and ASDAS, both at 3 months. There were changes in the concomitant medications profile, with regression of activity indexes increases at 6 months. Adverse events were reported by 33.7% patients at 3 months and 16.6% patients at 6 months, mostly disease flares and infectious events. Two patients stopped SB5. CONCLUSIONS: Despite temporary changes in the concomitant medication profile for mild disease flares, our real-life data replicate the safety profile of switching from ADA to SB5 in RA, with additional data for its applicability in PsA and axSpA patients, further supporting switching to biosimilars in treating inflammatory rheumatic conditions. Key Points • Switching from adalimumab originator to SB5 is feasible in real life rheumatic inflammatory joint diseases. • Mild disease flares can present after switching from originator adalimumab to SB5, in particular in axial spondyloarthritis and psoriatic arthritis. • Changes in concomitant medications profile allows the control of minor disease flares presenting after switching from adalimumab originator to SB5.
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Authors | Cosimo Bruni, Roberta Bitti, Francesca Nacci, Laura Cometi, Lorenzo Tofani, Francesca Bartoli, Ginevra Fiori, Marco Matucci-Cerinic |
Journal | Clinical rheumatology
(Clin Rheumatol)
Vol. 40
Issue 1
Pg. 85-91
(Jan 2021)
ISSN: 1434-9949 [Electronic] Germany |
PMID | 32514676
(Publication Type: Journal Article)
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Chemical References |
- Antirheumatic Agents
- Biosimilar Pharmaceuticals
- Adalimumab
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Topics |
- Adalimumab
(adverse effects)
- Adult
- Aged
- Antirheumatic Agents
(adverse effects)
- Arthritis, Psoriatic
(drug therapy)
- Arthritis, Rheumatoid
(drug therapy)
- Biosimilar Pharmaceuticals
(therapeutic use)
- Female
- Humans
- Middle Aged
- Treatment Outcome
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