Thymopentin Adverse effects: incidence study

Data on all reported side effects from 196 patients with rheumatoid arthritis taking thymopentin in the European clinical program were compared with those of 762 patients in a multicentre trial taking a commerical NSAID.

Overall, 45 patients (22%) taking thymopentin reported adverse drug experiences compared with 143 (18.8%) taking the NSAID. 30.5% of adverse reactions associated with thymopentin therapy were CNS related (19.4% for the NSAID) whereas 69.1 % were gastrointestinal side effects in patients taking the NSAID (18.6% for thymopentin). A further 18.6% of adverse reactions were skin-related for patients taking thymopentin (0.6% for the NSAID). The difference in rates of gastrointestinal and skin adverse reactions may be explained by the route of administration: the NSAID was given orally, whereas thymopentin was injected. None of the gastrointestinal effects necessitated withdrawal of therapy. Similarly, skin reactions were mild. The CNS-related effects (sleep disturbances and fatigue in some patients) may be associated with thymopentin's known effect on the neuromuscular junction.

A double-blind study compared haematological values for 21 patients with active rheumatoid arthritis given IV thymopentin 50mg over 10 minutes 3 times a week for 3 weeks, with 20 who received placebo. Significant changes occurred in the active treatment group (baseline vs value after 3 weeks' treatment) in erythrocytes (4.56 vs 4.38 x 1()6/mm3), haemoglobin (12.99 vs 12.61 g/l00ml) and haematocrit (39.1 vs 37.7 vol%). However, the changes seemed to be 'unique to this study'. After 2 weeks' thymopentin treatment, side effects reported and 'possibly' drug related, were 10 cases of somnolence, 19 of hypersomnia and 46 of itching. Dysaesthesia, 'probably' drug related, occurred in 46 cases. After 2 weeks' placebo treatment, 7 cases of asthenia and 42 of transpiration 'possibly' related to placebo were reported.After 3-7 weeks' thymopentin treatment, there were 46 reports of heavy menstrual flow and itching but their relationship to drug therapy was 'unknown'. In the placebo group 42 cases of transpiration were reported. The authors concluded that ' ... thymopentin appears to be a very safe drug when used according to the recommended dose regimens'. Weiss p. Stocker H. Survey of Immunological Research 4 (Suppl. 1): 149·154, Jull985

10 Reactions'" 8 Feb 1986 0157-7271/86/1026-0010/0S01.00/0 © ADIS Press

Thymopentin Adverse effects: incidence study

Data on all reported side effects from 196 patients with rheumatoid arthritis taking thymopentin in the European clinical program were compared with those of 762 patients in a multicentre trial taking a commerical NSAID.

Overall, 45 patients (22%) taking thymopentin reported adverse drug experiences compared with 143 (18.8%) taking the NSAID. 30.5% of adverse reactions associated with thymopentin therapy were CNS related (19.4% for the NSAID) whereas 69.1 % were gastrointestinal side effects in patients taking the NSAID (18.6% for thymopentin). A further 18.6% of adverse reactions were skin-related for patients taking thymopentin (0.6% for the NSAID). The difference in rates of gastrointestinal and skin adverse reactions may be explained by the route of administration: the NSAID was given orally, whereas thymopentin was injected. None of the gastrointestinal effects necessitated withdrawal of therapy. Similarly, skin reactions were mild. The CNS-related effects (sleep disturbances and fatigue in some patients) may be associated with thymopentin's known effect on the neuromuscular junction.

A double-blind study compared haematological values for 21 patients with active rheumatoid arthritis given IV thymopentin 50mg over 10 minutes 3 times a week for 3 weeks, with 20 who received placebo. Significant changes occurred in the active treatment group (baseline vs value after 3 weeks' treatment) in erythrocytes (4.56 vs 4.38 x 1()6/mm3), haemoglobin (12.99 vs 12.61 g/l00ml) and haematocrit (39.1 vs 37.7 vol%). However, the changes seemed to be 'unique to this study'. After 2 weeks' thymopentin treatment, side effects reported and 'possibly' drug related, were 10 cases of somnolence, 19 of hypersomnia and 46 of itching. Dysaesthesia, 'probably' drug related, occurred in 46 cases. After 2 weeks' placebo treatment, 7 cases of asthenia and 42 of transpiration 'possibly' related to placebo were reported.After 3-7 weeks' thymopentin treatment, there were 46 reports of heavy menstrual flow and itching but their relationship to drug therapy was 'unknown'. In the placebo group 42 cases of transpiration were reported. The authors concluded that ' ... thymopentin appears to be a very safe drug when used according to the recommended dose regimens'. Weiss p. Stocker H. Survey of Immunological Research 4 (Suppl. 1): 149·154, Jull985

10 Reactions'" 8 Feb 1986 0157-7271/86/1026-0010/0S01.00/0 © ADIS Press