PMID- 27236390 OWN - NLM STAT- MEDLINE DCOM- 20180119 LR - 20181113 IS - 0975-4466 (Electronic) IS - 0256-4947 (Print) IS - 0256-4947 (Linking) VI - 36 IP - 3 DP - 2016 May-Jun TI - Tocilizumab efficacy and safety in rheumatoid arthritis patients after inadequate response to disease-modifying anti-rheumatic drugs oranti-tumor necrosis factor. PG - 190-6 LID - 10.5144/0256-4947.2016.190 [doi] AB - BACKGROUND: Tocilizumab (TCZ) is a humanized anti-human IL-6R antibody, a novel therapy for rheumatoid arthritis (RA) patients who fail treatment with disease modifying anti-rheumatic drugs (DMARDs) or anti-tumor necrosis factor (anti-TNFs). OBJECTIVE: To assess the safety and efficacy of TCZ monotherapy or in combination with non-biologic DMARDs or anti-TNFs in moderate to severe active RA. DESIGN: Prospective, phase III, multi-center, open-label, single arm, 24-week trial. SETTING: Three centers in Saudi Arabia. PATIENTS AND METHODS: The study included consecutive RA patients infused with TCZ (8 mg/kg) over 60 minutes every 4 weeks (up to 6 times), either alone or with non-biologic DMARDs. Patients were followed for 24 weeks. Patients with good/moderate European League Against Rheumatism responses, continued on TCZ as long as commerically available or for 1 year. MAIN OUTCOME MEASURE(S): Disease activity measured by DAS28 score. RESULTS: Of 28 patients enrolled from 2 November 2011 to 12 May 2013 (18 months), 21 completed (77.8%) and 7 (25%) discontinued TCZ therapy. One patient was excluded from the intent-to-treat analysis. Efficacy analysis showed a significant difference (P < .0001) in the Disease Activity Score based on 28 joints and on swollen and tender joint counts. Three (10.7%) patients experienced at least one AE that was considered related to study drug (one probably and two possibly). Only one (3.6%) patient reported a severe adverse event (neutropenia and thrombocytopenia). No adverse events led to dose modification or death. CONCLUSION: TCZ monotherapy or in combination with non-biologic DMARDs resulted in a significant effect on the endpoints in moderate to severe RA in Saudi Arabia, which is consistent with other published reports. LIMITATIONS: No information on tapering of steroid therapy, lack of follow-up data of all 28 patients, lack of data on long-term effects of TCZ on lipid levels and the need for statins. (ClinicalTrials.gov identifier: NCT01326962). FAU - Abdulkader, Omer Ahmad Fatheddin AU - Abdulkader OAF AD - King Abdul-Aziz University Hospital, Jeddah, Saudi Arabia. FAU - Qushmaq, Khalid AU - Qushmaq K FAU - Aljishi, Faiza AU - Aljishi F LA - eng SI - ClinicalTrials.gov/NCT01326962 PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PL - Saudi Arabia TA - Ann Saudi Med JT - Annals of Saudi medicine JID - 8507355 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Antirheumatic Agents) RN - 0 (Tumor Necrosis Factor-alpha) RN - I031V2H011 (tocilizumab) SB - IM EIN - Ann Saudi Med. 2017 Jul-Aug;37(4):339. PMID: 28761038 MH - Adult MH - Antibodies, Monoclonal, Humanized/administration & dosage/adverse effects/*therapeutic use MH - Antirheumatic Agents/administration & dosage/adverse effects/*therapeutic use MH - Arthritis, Rheumatoid/*drug therapy/physiopathology MH - Drug Therapy, Combination MH - Female MH - Follow-Up Studies MH - Humans MH - Male MH - Middle Aged MH - Saudi Arabia MH - Severity of Illness Index MH - Treatment Outcome MH - Tumor Necrosis Factor-alpha/antagonists & inhibitors PMC - PMC6074539 EDAT- 2016/05/30 06:00 MHDA- 2016/05/30 06:01 PMCR- 2016/05/01 CRDT- 2016/05/30 06:00 PHST- 2016/05/30 06:00 [entrez] PHST- 2016/05/30 06:00 [pubmed] PHST- 2016/05/30 06:01 [medline] PHST- 2016/05/01 00:00 [pmc-release] AID - asm-3-190 [pii] AID - 10.5144/0256-4947.2016.190 [doi] PST - ppublish SO - Ann Saudi Med. 2016 May-Jun;36(3):190-6. doi: 10.5144/0256-4947.2016.190.