gms | German Medical Science

Introduction: The influence of BMI on the effectiveness of subcutaneous tocilizumab (TCZ s.c.) has not been systematically investigated in a prospective long-term study under real-world conditions. The non-interventional study ARATA (NCT02251860, first patient in 05/2014, last patient out 07/2020) analyzed for the first time effectiveness, safety and patient-reported outcomes (PROs) of TCZ s.c. in different BMI categories of rheumatoid arthritis (RA) patients in Germany over up to 2 years.

Methods: Analyzed BMI categories were normal weight (‘nw’, BMI ≥18.5 to ≤25 kg/m2, n=428 patients in the safety set), overweight (‘ow’, BMI 25 to ≤30 kg/m2, n=440 patients), and obese (‘ob’, BMI >30kg/m2, n=338 patients). RA Patients were treated with TCZ s.c. according to the German label (162 mg s.c. once per week per pre-filled pen or syringe).

Results: At baseline, patients with a higher BMI had more frequently comorbidities and a higher RA disease activity. During the study, they experienced more frequently Adverse Events (AEs), Serious AEs and AEs of Special Interest. The highest BMI category had a shorter treatment duration (ob 63.2±41.9 weeks, ow 67.6±41.1 weeks, nw 71.8±41.9 weeks) and a higher TCZ s.c. discontinuation rate (ob 113/338 [33.4%], ow 133/440 [30.2%], nw 100/438 [22.8%] patients). Similar proportions of patients in the BMI subgroups reached DAS28-ESR functional remission up to week 104 (nw: 73.5% [303/412], ow: 74.1% [297/401], ob: 69.8% [222/318] patients; baseline nw: 7.1% [24/338], ow: 3.5% [11/313], ob: 2.4% [6/253] patients). RA patients in the highest BMI category reported numerically higher mean pain and fatigue scores and Beck Depression Inventory II scores than RA patients in the two lower analyzed BMI categories. Mean sleep disturbance scores were higher in RA patients in the two higher BMI categories. Pain, fatigue, depression and sleep disturbance improved in all BMI categories during the ARATA study.

Conclusion: TCZ s.c. was shown to be an effective and safe therapy that reduced pain, fatigue, sleep disturbance and depression in RA patients in all analyzed BMI categories ≥18.5 in daily clinical practice in Germany.

Disclosure: Conflicts of Interest: F. Behrens received research grants, consulting fees, travel support, and/or speaker’s fees from Abbvie, Affibody, Amgen, Bionorica, BMS, Boehringer-Ingelheim, Chugai, Iron4u, Leo, Lilly, Galapagos, Genzyme, GSK, Moon-Lake, MSD, Novartis, Janssen-Cilag, Novartis, Pfizer, Roche, Sandoz, Sanofi, and UCB. G.R. Burmester received speaker’s fees, funding for research or training, or compensation for consultancies or board memberships from Roche, Sanofi and Chugai Pharma Germany GmbH. D. Strotkamp is an employee of Chugai Pharma Germany GmbH. M. Aringer received consulting fees, and/or speaker’s fees from Abbvie, BMS, Chugai, Galapagos, Lilly, MSD, Pfizer, Roche, Sanofi, and UCB. S. Wassenberg received research funding from Fraunhofer Society, speakers’ honoraria from Abbvie, Celgene, Lilly, Hexal, MSD, Pfizer, and Sanofi, consultancy fees from Abbvie, Amgen, BMS, Gilead, Lilly, Nichi-Iko, Pfizer and Sanofi, and grants from Pfizer. C. Amberger received speaker’s fees, funding for research or training, or compensation for consultancies or board memberships from Abbvie, Amgen, BMS, Chugai, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, and Roche.

Acknowledgements: Medical writing support, under the guidance of the authors, was provided by Kirsten Dahm, PhD (AMS Advanced Medical Services GmbH, Mannheim, Germany) and funded by Chugai Pharma Germany.