PMID- 33236554
OWN - NLM
STAT- MEDLINE
DCOM- 20201204
LR  - 20201214
IS  - 1565-1088 (Print)
VI  - 22
IP  - 9
DP  - 2020 Sep
TI  - A Study of the Efficacy and Safety of Subcutaneous Injections of Tocilizumab in 
      Adults with Rheumatoid Arthritis.
PG  - 557-563
AB  - BACKGROUND: Tocilizumab is an interleukin 6 (IL-6) receptor antagonist used treat 
      moderate to severe active rheumatoid arthritis (RA). Both intravenous (IV) and 
      subcutaneous (SC) routes are approved for the treatment of adults with RA. 
      OBJECTIVES: To evaluate SC tocilizumab in a real-life clinical setting. METHODS: 
      Our study was a multi-center, open-label, single-arm study. Participants were 
      adults with a diagnosis of active RA, previously treated with disease-modifying 
      antirheumatic drugs (DMARDs), with or without biologic agents. Participants 
      received a weekly SC injection of tocilizumab 162 mg as monotherapy or in 
      combination with methotrexate or DMARDs for 24 weeks. Efficacy, safety, and 
      immunogenicity were assessed. RESULTS: Treatment of 100 patients over 24 weeks 
      resulted in improvement in all efficacy parameters assessed: Clinical Disease 
      Activity Index, Disease Activity Score using 28 joint counts and erythrocyte 
      sedimentation rate, American College of Rheumatology response scores, Simplified 
      Disease Activity Index, tender and swollen joint counts, and patient-reported 
      outcomes including fatigue, global assessment of disease activity, pain, and 
      Health Assessment Quality of Life Disease Index. Improvement was achieved as 
      early as the second week of treatment. There were 473 adverse events (AEs)/100 
      patient-years (PY) and 16.66 serious AEs/100 PY. The most common AEs were 
      neutropenia (12%), leukopenia (11%), and increased hepatic enzymes (11%). Of a 
      total of 42 PY, the rates of serious infections and AEs leading to 
      discontinuation were 4.8, and 11.9 events/100 PY, respectively. CONCLUSIONS: The 
      safety, tolerability, and efficacy profile of tocilizumab SC were comparable to 
      those reported in other studies evaluating the IV and SC routes of 
      administration.
FAU - Langevitz, Pnina
AU  - Langevitz P
AD  - Department of Rheumatology, Sheba Medical Center, Tel Hashomer, Israel.
AD  - Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Lidar, Merav
AU  - Lidar M
AD  - Department of Rheumatology, Sheba Medical Center, Tel Hashomer, Israel.
FAU - Rosner, Itzhak
AU  - Rosner I
AD  - Department of Rheumatology, Bnai Zion Medical Center, Haifa, Israel.
FAU - Feld, Joy
AU  - Feld J
AD  - Rheumatology Unit, Carmel Medical Center, Haifa, Israel.
FAU - Tishler, Moshe
AU  - Tishler M
AD  - Department of Internal Medicine B, Assaf Harofeh Medical Center, Zerifin, Israel.
FAU - Amital, Howard
AU  - Amital H
AD  - Department of Internal Medicine B, Sheba Medical Center, Tel Hashomer, Israel.
FAU - Aamar, Suhail
AU  - Aamar S
AD  - Rheumatology Unit, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.
FAU - Elkayam, Ori
AU  - Elkayam O
AD  - Department of Rheumatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
FAU - Balbir-Gurman, Alexandra
AU  - Balbir-Gurman A
AD  - Shine Rheumatology Institute, Rambam Health Care Campus, Haifa, Israel.
FAU - Abu-Shakra, Mahmoud
AU  - Abu-Shakra M
AD  - Rheumatology Disease Unit, Soroka University Medical Center, Beer Sheva, Israel.
FAU - Mevorach, Dror
AU  - Mevorach D
AD  - Department of Internal Medicine, Hadassah-Hebrew University Medical Center, 
      Jerusalem, Israel.
FAU - Kimhi, Oded
AU  - Kimhi O
AD  - Department of Internal Medicine A, Meir Medical Center, Kfar Saba, Israel.
FAU - Molad, Yair
AU  - Molad Y
AD  - Rheumatology Unit, Rabin Medical Center (Beilinson Campus), Petah Tikva, Israel.
AD  - Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
FAU - Kuperman, Ana
AU  - Kuperman A
AD  - Rheumatology Clinic, Rabin Medical Center (Hasharon Campus), Petah Tikva, Israel.
FAU - Ehrlich, Sharon
AU  - Ehrlich S
AD  - Roche Pharmaceuticals (Israel) Ltd., Hod HaSharon, Israel.
LA  - eng
PT  - Clinical Study
PT  - Journal Article
PT  - Multicenter Study
PL  - Israel
TA  - Isr Med Assoc J
JT  - The Israel Medical Association journal : IMAJ
JID - 100930740
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antirheumatic Agents)
RN  - I031V2H011 (tocilizumab)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage/adverse effects
MH  - Antirheumatic Agents/*administration & dosage/adverse effects
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Male
MH  - Methotrexate/administration & dosage/adverse effects
MH  - Middle Aged
MH  - Patient Reported Outcome Measures
EDAT- 2020/11/26 06:00
MHDA- 2020/12/15 06:00
CRDT- 2020/11/25 05:53
PHST- 2020/11/25 05:53 [entrez]
PHST- 2020/11/26 06:00 [pubmed]
PHST- 2020/12/15 06:00 [medline]
PST - ppublish
SO  - Isr Med Assoc J. 2020 Sep;22(9):557-563.