菌状息肉症を対象とした遺伝子組換え型IL-1β誘導体(OCT-43)の後期臨床第II相試験

A multicenter late phase II study of recombinant IL-1β derivative (OCT-43) was performed in patients with mycosis fungoides at 37 institutions nationwide. This study consisted of two stages, one to find the optimal dosage and regimen and the other to evaluate clinical efficacy at the optimal dosage and regimen. OCT-43 was administered by the subcutaneous route at a daily dose of 2.5×104 JRU or 7.5×104JRU, twice a week on 2 consecutive days with a 5-day rest, for 6 weeks or longer. The optimal dosage and regimen for the administration of OCT-43 was concluded to besubcutaneous administration once daily at a dose of 2.5×104 JRU or 7.5×104 JRU, adjusting the dose in accordance with the occurrence of adverse reactions and theseverity of the symptoms. Thus, the second stage of the study was performed usingthese dosages and regimen for 6 weeks or longer. Of a combined total of 37 completedcases in both stages of the study, complete response (CR) was observed in 1 case and partial response (PR) in 18 cases, for an overall response rate of 51.4%. The responserates in the individual study phases were 41.2% (7/17) in the dosage and regimen-Finding stage and 60.0% (12/20) in the efficacy-evaluation stage. Major subjectivesymptoms and objective signs consisted of fever (82.1%, 32/39), chills (61.5%, 24/39), and general fatigability (53.8%, 21/39), and clinical laboratory tests showed positiveCRP (93.8%, 30/32), an increase in RBC sedimentation (83.3%, 20/24), and an increasein WBC count (63.2%, 24/38) . Three completed cases were withdrawn at the end of the study due to adverse reactions: 1 case due to worsening of erythema and swelling in rash, 1 due to fever and headache, and l due to diarrhea. These results indicate that although OCT-43 may cause some adverse reactions which require careful attention, this drug is highly useful in the treatment of mycosis fungoides.