Quality of Life Changes with Canakinumab Therapy in Adults with Colchicine Resistant FMF

Ahmet Gul¹, Huri Ozdogan², Ozgur Kasapcopur³, Burak Erer⁴, Serdal Ugurlu⁵, S. Sevgi⁶ and Soner Turgay⁷, ¹Department of Internal Medicine, Rheumatology Division, Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey, ²Division of Rheumatology, Department of Internal Medicine, Cerrahpasa Medical Faculty, University of Istanbul, Istanbul, Turkey, ³Istanbul University, Cerrahpasa Medical School, Department of Pediatric Rheumatology, Professor of Pediatric Rheumatology, Istanbul, Turkey, ⁴Istanbul Faculty of Medicine, Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey, ⁵Rheumatology, Division of Rheumatology, Department of Internal Medicine, Cerrahpasa Medical Faculty, University of Istanbul, Istanbul, Turkey, ⁶Novartis Pharma, Istanbul, Turkey, ⁷Medical, Novartis Pharma, İstanbul, Turkey

Meeting: ACR/ARHP Annual Meeting 2015

Date of first publication: September 29, 2015

Keywords: Autoinflammation, canakinumab, familial Mediterranean fever and quality of life, New Therapeutics

Session Information

Date: Sunday, November 8, 2015

Title: Miscellaneous Rheumatic and Inflammatory Diseases Poster I

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose:

Introduction:Familial Mediterranean Fever (FMF), the most common form of the hereditary autoinflammatory disorders, is characterized by recurrent attacks of fever along with serosal or synovial inflammation lasting usually 12 to 72 hours. FMF is associated with impaired functional ability, and the persistent disabling features and chronic pain, emotional and physical limitations can have a negative impact on the health-related quality of life (QoL) of the patients.

There is no established treatment available for those resistant or intolerant to standard of care colchicine treatment. Interleukin-1 (IL-1) plays a pivotal role in the pathogenesis of crFMF. Canakinumab, a fully human, selective, anti-IL-1β monoclonal antibody, binds to IL-1β and inactivates its signalling activity. Gul et al. have described the efficacy and safety of canakinumab in adults with colchicine resistant (cr) FMF in a local pivotal phase II trial. Here, we report the effect of canakinumab treatment on QoL measured by SF-36 Questionnaire.

Objectives: This study aimed to show the effects of canakinumab treatment on quality of life by 8 sub-items of SF-36 as well as to see the correlation between the physician global assessments and SF-36 scores.

Methods:

crFMF patients with ≥1 attack/month in the preceding 3-months despite the highest tolerated colchicine dose entered the study. Canakinumab injections were administered at Day 1, Day 29 and Day 57. Changes in the quality of life was recorded in 9 subjects by using SF-36 at Day 1, 8, 29,57, 86,115 and the end of the study.

Results:

In all 8 sub-items (physical functioning, role limitations due to emotional/physical health, energy, emotional-well being, body pain, social functioning and general health) of SF-36 scores improved dramatically with canakinumab treatment, starting from 1st day. However the differences in emotional well-being and role limitations due to emotional problems scores couldn’t reach the statistical significance. All scores are showed in tables below. Also there was a strong negative correlation between Physician Global Assessment (PGA) and Physical Component Score(PGS) (R-sq: -0,793). A weaker correlation observed between Mental Component Score(MCS) and Physical Global Assessment (R-sq: -0,540).

Conclusion:

Canakinumab treatment in cr-FMF patients resulted in a rapid improvement in QoL measures. Also these improvements sustained during the withdrawal period. PGA scores seem to be correlating well with SF-36 scores. In addition, Physical Component Score matches with PGA more than Mental Component Score.

Disclosure: A. Gul, None; H. Ozdogan, None; O. Kasapcopur, None; B. Erer, None; S. Ugurlu, None; S. Sevgi, Novartis Pharmaceutical Corporation, 3; S. Turgay, Novartis Pharmaceutical Corporation, 3.

To cite this abstract in AMA style:

Gul A, Ozdogan H, Kasapcopur O, Erer B, Ugurlu S, Sevgi S, Turgay S. Quality of Life Changes with Canakinumab Therapy in Adults with Colchicine Resistant FMF [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/quality-of-life-changes-with-canakinumab-therapy-in-adults-with-colchicine-resistant-fmf/. Accessed .

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