Thymopentin therapy reduces the clinical severity of atopic dermatitis.

One hundred patients with moderate to severe atopic dermatitis were entered into a two-center, double-blind trial. Patients were randomized to receive either thymopentin (Timunox, n = 48) or placebo (n = 52), administered as daily subcutaneous injections for 6 weeks. Clinical extent of disease and severity parameters were measured at baseline and at regular time intervals during the study. Both the placebo- and thymopentin-treated groups demonstrated a progressive and statistically significant (p less than 0.001) decline in the overall severity of their disease, but reduction in the clinical severity score was higher in the thymopentin-treated group and statistically significant (p = 0.04) in comparison with the placebo-treated group after 6 weeks of treatment. Of the individual symptoms comprising the total severity score, pruritus (p = 0.02) and erythema (p = 0.04) were reduced significantly when thymopentin therapy was compared to placebo therapy. In addition, both the extent of body involvement and severity index (a combined severity/extent index) were significantly reduced after 6 weeks in the thymopentin-treated group in comparison to the placebo-treated group (p = 0.04). There were no serious adverse experiences in either treatment group. We conclude that treatment with thymopentin is safe and offers significant therapeutic promise for atopic dermatitis.

Thymopentin (TP-5) in the treatment of rheumatoid arthritis.

A randomized control trial of TP-5 in rheumatoid arthritis is reported. In a multicentre study, 76 patients were treated with TP-5 50 mg or placebo three times a week for 3 weeks as a slow intravenous injection, and followed for 7 weeks. Clinical parameters such as the Ritchie index and sum score of swollen joints improved significantly on TP-5 compared to placebo. Laboratory parameters did not change but an increased skin test score to common recall antigens was observed. Toxicity was minimal. TP-5 is a potentially useful agent in the treatment of rheumatoid arthritis, although further studies are required to determine the optimal treatment regimen.

[Immunomodulating therapy in chronic polyarthritis with thymopentin. A multicenter placebo-controlled study of 119 patients]. / Immunmodulierende Therapie der chronischen Polyarthritis mit Thymopentin. Eine multizentrische placebokontrollierte Studie an 119 Patienten.

In a multicenter, placebo-controlled and randomized double-blind trial 119 patients with rheumatoid arthritis were treated with thymopentin, an immunoregulating drug. The data of 107 patients were complete enough to be evaluated: 51 were given intravenous injections over ten minutes of 50 mg thymopentin three times weekly, 56 were similarly treated with a placebo solution. Significant improvement of five among nine clinical criteria were obtained with thymopentin after the third week of treatment. The response rate (improvement of a clinical parameter by at least 40%) was significantly greater for all clinical parameters in the thymopentin group. Regression to a functionally more favourable class (Steinbrocker's classification) occurred in seven thymopentin-treated, but in none of the placebo-treated patients. The improvement gradually subsided over four weeks after the end of treatment. There were no changes during the trial with respect to immunological, biochemical or haematological findings. Except for one systemic allergic reaction there were no side effects.

Thymopentin: safety overview.

This paper reviews all available data on thymopentin derived from the extensive preclinical safety program; most of those studies have been concluded, only the carcinogenicity studies are nearing completion. The overview also compiles the safety parameters generated from patients treated with thymopentin for different clinical conditions; in some cases treatment lasted for 12-24 months (56 patients). Different doses and modes of administration were used. The percentage of patients with side effects was comparable to the incidences in the placebo groups. Thymopentin was also well tolerated when administered concomitantly with a long list of drugs given for other reasons. The overall conclusion in that thymopentin is a safe compound.

Safety of thymopentin. Data from European clinical studies.

The safety data collected from 196 patients treated with thymopentin during the clinical development of this compound in Europe are reviewed and compared with the incidence of adverse drug reactions experienced when using a commercial nonsteroid anti-inflammatory drug. Quantitatively side effects are reported in the same range for both drugs, however, they appear to be quite different when classified by body systems. Some patients complained about somnolence, and it is speculated whether this symptom might be related to thymopentin's known effect on the neuromuscular junction. The general conclusion is that thymopentin is an extremely well tolerated drug when used according to the dose regimens recommended.

Thymopentin in active rheumatoid arthritis. An open, monitored study in 16 patients.

The present paper reports on 16 patients with active rheumatoid arthritis who were treated with thymopentin administered as intravenous prolonged injections (one push of 5 mg every minute for 10 min) three times weekly for 3 consecutive weeks. Thirteen patients were evaluated, including a follow-up period of 2 months. Most patients improved clinically already after 5 injections. The overall data showed a statistically significant improvement (p less than 0.05) at the end of treatment; this favorable effect lasted for 6-7 weeks after thymopentin was discontinued. Standard laboratory tests and immunological parameters did not reveal any meaningful findings, hence, it can only be speculated about thymopentin's mechanism of action. It is suggested that the dose regimen is very critical as to therapeutic outcome when using an immunomodulating drug in clinical medicine.

Confirmative study of the effectiveness of thymopentin in active rheumatoid arthritis.

Forty-one patients with active rheumatoid arthritis entered a controlled double-blind randomized study. Of these patients, 21 received prolonged intravenous injections (10 min) of thymopentin 50 mg three times a week for 3 consecutive weeks, whereas 20 received placebo. Both groups were comparable with regard to clinical parameters. No immunological tests were performed. Analysis of the results after 3 weeks showed that the improvement in the thymopentin group was statistically significant (p less than 0.05 or p less than 0.01) for all clinical parameters, except for the left-hand grip strength. On the other hand, no significant improvement was observed for any parameter, except morning stiffness, in the patients on placebo. The intergroup comparison showed statistically significant differences, favoring thymopentin over placebo treatment, in the Ritchie index, the scores of swollen joints, the assessment of severity of pain, and the scores for changes in the activity of the disease. The present placebo-controlled double blind study thus confirms the positive results generated in a similar open study, i.e., the beneficial therapeutic effect of prolonged intravenous injections of thymopentin in patients with severe rheumatoid arthritis. The drug appears to be safe at the dose regimen used.

Interim results on the clinical effects of i.v. administered thymopentin in active rheumatoid arthritis.

Forty-one patients with active rheumatoid arthritis entered a controlled, double-blind, randomized study; 21 received prolonged i.v. injections (10 min) of thymopentin 50 mg 3 times a week for 3 consecutive weeks; the other 20 received placebo under the same conditions. The groups were comparable at the start of the study. Statistical tests of changes within the treatment groups after 3 weeks showed that the improvement achieved in the thymopentin group was significant (p less than 0.05 or p less than 0.01) for each clinical parameter, except for left-hand grip strength. On the other hand, no significant improvement was observed for any parameter except morning stiffness in the patients on placebo. The intergroup comparison showed significant differences, favouring thymopentin over placebo treatment, in the Ritchie index, scores for swollen joints, assessment of severity of pain and scores for changes in the activity of the disease. Only minor side-effects were experienced in the two treatment groups. The present placebo-controlled double-blind study confirms the previous positive results achieved in open studies, i.e., the beneficial therapeutic effect of prolonged i.v. injections of thymopentin in patients with severe rheumatoid arthritis observed after 3 weeks of therapy. The drug appears to be safe at the dose regimen used.

Thymopoietin in rheumatoid arthritis.

In a controlled study involving 36 patients, thymopoietin was shown to be more effective than levamisole and as effective as penicillamine in improving the clinical status of patients with rheumatoid arthritis. There were small reductions in erythrocyte sedimentation rate and IgG which did not achieve statistical significance. Rheumatoid factor titre did not change. Although its mechanism of action is almost certainly related to its immunomodulatory properties it does not seem to be the same as that of levamisole.