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Tumour necrosis factor inhibitors (TNFi) are effective in the majority of patients with rheumatoid arthritis (RA),1 however, an important reason for non-response is low drug level due to immunogenicity.2 To our knowledge, no data collected during a prospective observational study is currently available regarding the relationship between golimumab level, immunogenicity and response in RA.
This prospective observational cohort consisted of 37 consecutive adult patients with RA, according to the American College of Rheumatology 1987 revised criteria,3 in whom golimumab 50 mg subcutaneously once monthly was initiated according to the judgment of the rheumatologist, and who were recruited from two departments (Spain and The Netherlands). The study was approved by both Medical Ethics Committees. Clinical response was defined as Disease Activity Score using 28 joint count (DAS28) <3.2, calculated with erythrocyte sedimentation rate (ESR) (mm/h). Patients were eligible for inclusion when clinical data and sera of baseline with ≥ one follow-up visit were available.
Clinical measurements and trough-level sera were collected at baseline and 4, 16, 28 and 52 weeks (The Netherlands), or half yearly (Spain), thereafter. Golimumab levels were measured analogously to adalimumab4 using TNF for capture and rabbit antigolimumab for detection …
Contributors Study concept and design: ELK, CP, CLMK, DP-S, DvdK, MTN, MTL-C, RW, TR, GW. Acquisition of data: ELK, CP, DP-S. Analysis and interpretation of the data: ELK, CP, GW. Clinical revision and drafting of the manuscript for important intellectual content: ELK, CP, CLMK, DP-S, Dv dK, MTN, MTL-C, RW, TR, GW. Obtained funding: none. Study supervision: MTN, GW. Final approval: ELK, CP, CLMK, DP-S, DvdK, MTN, MTL-C, RW, TR, GW.
Competing interests MTN reports having received consultancy fees from Abbott, Roche, Pfizer, MSD, UCB, SOBI and BMS, payment for lectures from Abbott, Roche and Pfizer. GW reports having received a research grant from Pfizer (Wyeth) (paid to the institution) and payments for lectures from Pfizer, UCB, Abbvie and Amgen. CLMK reports having received payment for lectures from AbbVie and Pfizer. TR reports having received payment for lectures from AbbVie and Pfizer. CP reports having received a research grant from Pfizer. DP-S reports having received payments for lectures from Pfizer and a research grant from Pfizer. ELK reports having received payments for lectures from Pfizer. DvdK, MTL-C and RW have no disclosures
Patient consent Obtained.
Ethics approval The study was approved by the Medical Ethics Committee of the Slotervaart Hospital and Jan van Breemen Research Institute | Reade, Amsterdam (The Netherlands) and La Paz Hospital, Madrid (Spain).
Provenance and peer review Not commissioned; externally peer reviewed.