Abstract | OBJECTIVE: METHODS: This is a posthoc analysis of the noninterventional, prospective, GO-NICE study in the subgroup of biologic-naive AS treated with golimumab (GOL) 50 mg subcutaneously once monthly. RESULTS: Of the 244 biologic-naive AS patients at baseline, 70.5% had a BASDAI ≥ 4 (Group 1), 14.3% had 2.8 to < 4 (Group 2), and 15.2% had even < 2.8 (Group 3). A total of 134 patients (54.9%) completed the 24-month observational period. The mean BASDAI in Groups 1, 2, and 3 was initially 5.9 ± 1.3, 3.4 ± 0.4, and 2.0 ± 0.8, decreased to 2.2 ± 2.0, 1.9 ± 1.2, and 1.0 ± 1.2 within 3 months (all p < 0.0001 vs baseline), and decreased significantly to 2.2 ± 1.7, 1.9 ± 1.7, and 1.4 ± 1.0 at Month 24 (all p < 0.005), respectively. BASDAI 50% improvement was noted in 68.8%, 44.8%, and 45.2% of patients at Month 3, and in 84.9%, 61.9%, and 55.0% at Month 24. CONCLUSION: TNFi treatment was initiated in almost a third of AS patients with lower disease activity states as assessed by BASDAI cutoff of ≥ 4. Patients with a BASDAI between 2.8 and < 4 appeared to benefit significantly from GOL treatment, while patients with BASDAI < 2.8 did not. This finding should lead to a reevaluation of the established BASDAI cutoff of ≥ 4.
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Authors | Jürgen Braun, Xenofon Baraliakos, Uta Kiltz, Klaus Krüger, Gerd R Burmester, Siegfried Wassenberg, Matthias H Thomas |
Journal | The Journal of rheumatology
(J Rheumatol)
Vol. 47
Issue 1
Pg. 35-41
(01 2020)
ISSN: 0315-162X [Print] Canada |
PMID | 30877206
(Publication Type: Journal Article, Multicenter Study, Observational Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal
- Antirheumatic Agents
- Biological Products
- TNF protein, human
- Tumor Necrosis Factor Inhibitors
- Tumor Necrosis Factor-alpha
- golimumab
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Topics |
- Adolescent
- Adult
- Aged
- Antibodies, Monoclonal
(administration & dosage)
- Antirheumatic Agents
(administration & dosage)
- Biological Products
(administration & dosage)
- Female
- Follow-Up Studies
- Germany
(epidemiology)
- Humans
- Male
- Middle Aged
- Prospective Studies
- Severity of Illness Index
- Spondylitis, Ankylosing
(drug therapy, epidemiology)
- Treatment Outcome
- Tumor Necrosis Factor Inhibitors
(administration & dosage)
- Tumor Necrosis Factor-alpha
(antagonists & inhibitors)
- Young Adult
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