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Efficacy and safety of canakinumab in adolescents and adults with colchicine-resistant familial Mediterranean fever.

Gül A, Ozdogan H, Erer B, Ugurlu S, Kasapcopur O, Davis N, Sevgi S - Arthritis Res. Ther. (2015)

Bottom Line: Primary efficacy outcome measure was the proportion of patients with 50 % or more reduction in attack frequency.All 9 patients achieved a 50 % or more reduction in attack frequency, and only one patient had an attack during the treatment period.Five patients had an attack during the 2-month follow-up, occurring median 71 (range, 31 to 78) days after the last dose.

View Article: PubMed Central - PubMed

Affiliation: Istanbul Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, 34093 Fatih, Istanbul, Turkey. agul@istanbul.edu.tr.

ABSTRACT

Introduction: This open-label pilot study aimed to investigate the efficacy of canakinumab in colchicine-resistant familial Mediterranean fever (FMF) patients.

Method: Patients with one or more attacks in a month in the preceding 3 months despite colchicine were eligible to enter a 30-day run-in period. Patients who had an attack during the first run-in period advanced to a second 30-day period. At the first attack, patients started to receive three canakinumab 150 mg subcutaneous injections at 4-week intervals, and were then followed for an additional 2 months. Primary efficacy outcome measure was the proportion of patients with 50 % or more reduction in attack frequency. Secondary outcome measures included time to next attack following last canakinumab dose and changes in quality of life assessed by SF-36.

Results: Thirteen patients were enrolled in the run-in period and 9 advanced to the treatment period. All 9 patients achieved a 50 % or more reduction in attack frequency, and only one patient had an attack during the treatment period. C-reactive protein and serum amyloid A protein levels remained low throughout the treatment period. Significant improvement was observed in both physical and mental component scores of the Short Form-36 at Day 8. Five patients had an attack during the 2-month follow-up, occurring median 71 (range, 31 to 78) days after the last dose. Adverse events were similar to those observed in the previous canakinumab trials.

Conclusion: Canakinumab was effective at controlling the attack recurrence in patients with FMF resistant to colchicine. Further investigations are warranted to explore canakinumab's potential in the treatment of patients with colchicine resistant FMF.

Trial registration: ClinicalTrials.gov NCT01088880 . Registered 16 March 2010.

No MeSH data available.


Related in: MedlinePlus

Physician’s global assessment of control of familial Mediterranean fever over the previous month. EOS end of study
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Fig2: Physician’s global assessment of control of familial Mediterranean fever over the previous month. EOS end of study

Mentions: The median SF-36 physical and mental component scores increased dramatically at day 8 compared with baseline scores and continued to improve throughout the treatment period (Additional file 3: Figure S2). Compared with baseline, the physician’s and patient’s global assessment of crFMF control improved with canakinumab treatment, and overall treatment response was reported as being very good both by physicians (for all patients) and patients (seven of nine patients) at the end of study (Fig. 2).Fig. 2


Efficacy and safety of canakinumab in adolescents and adults with colchicine-resistant familial Mediterranean fever.

Gül A, Ozdogan H, Erer B, Ugurlu S, Kasapcopur O, Davis N, Sevgi S - Arthritis Res. Ther. (2015)

Physician’s global assessment of control of familial Mediterranean fever over the previous month. EOS end of study
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4559892&req=5

Fig2: Physician’s global assessment of control of familial Mediterranean fever over the previous month. EOS end of study
Mentions: The median SF-36 physical and mental component scores increased dramatically at day 8 compared with baseline scores and continued to improve throughout the treatment period (Additional file 3: Figure S2). Compared with baseline, the physician’s and patient’s global assessment of crFMF control improved with canakinumab treatment, and overall treatment response was reported as being very good both by physicians (for all patients) and patients (seven of nine patients) at the end of study (Fig. 2).Fig. 2

Bottom Line: Primary efficacy outcome measure was the proportion of patients with 50 % or more reduction in attack frequency.All 9 patients achieved a 50 % or more reduction in attack frequency, and only one patient had an attack during the treatment period.Five patients had an attack during the 2-month follow-up, occurring median 71 (range, 31 to 78) days after the last dose.

View Article: PubMed Central - PubMed

Affiliation: Istanbul Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology, 34093 Fatih, Istanbul, Turkey. agul@istanbul.edu.tr.

ABSTRACT

Introduction: This open-label pilot study aimed to investigate the efficacy of canakinumab in colchicine-resistant familial Mediterranean fever (FMF) patients.

Method: Patients with one or more attacks in a month in the preceding 3 months despite colchicine were eligible to enter a 30-day run-in period. Patients who had an attack during the first run-in period advanced to a second 30-day period. At the first attack, patients started to receive three canakinumab 150 mg subcutaneous injections at 4-week intervals, and were then followed for an additional 2 months. Primary efficacy outcome measure was the proportion of patients with 50 % or more reduction in attack frequency. Secondary outcome measures included time to next attack following last canakinumab dose and changes in quality of life assessed by SF-36.

Results: Thirteen patients were enrolled in the run-in period and 9 advanced to the treatment period. All 9 patients achieved a 50 % or more reduction in attack frequency, and only one patient had an attack during the treatment period. C-reactive protein and serum amyloid A protein levels remained low throughout the treatment period. Significant improvement was observed in both physical and mental component scores of the Short Form-36 at Day 8. Five patients had an attack during the 2-month follow-up, occurring median 71 (range, 31 to 78) days after the last dose. Adverse events were similar to those observed in the previous canakinumab trials.

Conclusion: Canakinumab was effective at controlling the attack recurrence in patients with FMF resistant to colchicine. Further investigations are warranted to explore canakinumab's potential in the treatment of patients with colchicine resistant FMF.

Trial registration: ClinicalTrials.gov NCT01088880 . Registered 16 March 2010.

No MeSH data available.


Related in: MedlinePlus