Bullous Pemphigoid (BP) Is An Auto-Immune Skin Disease Which Can Be Fatal, Particularly In Patients Who Are Debilitated

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Three relatively new medical studies add weight to an emerging drug safety issue involving Tradjenta (linagliptin), which is part of the dipeptidyl peptidase 4 (DPP-4) inhibitors class of type 2 diabetes drugs.

Before getting to the recent medical journal articles which seem to show that an increased risk of bullous pemphigoid (BP) is a side effect associated with Tradjenta, we point out that at least three other diabetes drugs also contain linagliptin, which is the active ingredient in Tradjenta:

• Glyxambi (empagliflozin and linagliptin)
• Jentadueto (linagliptin and metformin hydrochloride)
• Jentadueto XR (linagliptin and metformin hydrochloride)

The first medical journal article, "Association of Bullous Pemphigoid With Dipeptidyl-Peptidase 4 Inhibitors in Patients With Diabetes", provides findings from a retrospective case-control study, and was published online August 8, 2018 in the medical journal JAMA Dermatology.

From the Abstract for this first article we get the following Tradjenta safety information:

Importance:  The association of bullous pemphigoid (BP) with the use of dipeptidyl-peptidase 4 (DPP-4) inhibitors among patients with diabetes has recently emerged. The risk of developing BP during treatment with new DPP-4 inhibitor agents like [Tradjenta (linagliptin)] is yet to be established….

Results:  Eighty-two patients with BP and 328 age- and sex-matched control participants were enrolled; mean (SD) age, 79.1 (9.1) years; and 44 patients were female (53.7%). Overall, DPP-4 inhibitor intake was associated with a 3-fold increased risk for BP (adjusted odds ratio [OR], 3.2; 95% CI, 1.9-5.4). The adjusted ORs for [Galvus (vildagliptin)] and [Tradjenta (linagliptin)] were 10.7 (95% CI, 5.1-22.4) and 6.7 (95% CI, 2.2-19.7), respectively…. Discontinuation of DPP-4 inhibitor treatment was followed by improved clinical outcomes.

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We note that Galvus is not FDA-approved at this time, i.e., 8/20/2018.

The second medical journal article, "Bullous Pemphigoid and Dipeptidyl Peptidase 4 Inhibitors: A Disproportionality Analysis Based on the Japanese Adverse Drug Event Report Database", was published online July 12, 2018 in the medical journal Diabetes Care.

For this second article, we get a concise summary of relevant points from an August 9, 2018 Medscape report, "Type 2 Diabetes Drugs Linked to Bullous Pemphigoid":

In the earlier Diabetes Care study, Masanori Arai, MD, of the department of endocrinology and metabolism, Graduate School of Medicine, Yokohama City University, Japan, and colleagues, identified 546 bullous pemphigoid cases from the Japanese Adverse Drug Event Report (JADER) database, of which 392 were associated with DPP4 inhibitor use.

The JADER contains all pharmacovigilance data spontaneously reported to Japan's Pharmaceuticals and Medical Devices Agency since April 2004.

In an adjusted analysis, reported odds ratios for bullous pemphigoid by individual DPP4 inhibitor were 2.67 for [Tradjenta (linagliptin)]… and 12.09 for [Galvus (vildagliptin)].

The third article, "Dipeptidyl peptidase‐4 inhibitors‐associated bullous pemphigoid: A retrospective study of 168 pemphigoid and 9,304 diabetes mellitus patients", was published June 19, 2018 by the Journal of Diabetes Investigation (JDI).

From the Abstract for this third article we get some general background information which is relevant to the Tradjenta – bullous pemphigoid drug safety issue:

Aims/Introduction:  Bullous pemphigoid (BP) might be drug‐induced. The present study evaluated the relationship between BP and dipeptidyl peptidase‐4 inhibitors (DPP4Is).

Conclusions:  The positive rate of anti‐BP180NC16a antibody was lower in BP patients with DPP4I than without DPP4I, regardless of type 2 diabetes mellitus. The antibody titer was low in both the overall and type 2 diabetes mellitus populations. The prevalence of BP in 9,304 patients receiving DPP4Is was 0.0859%, which is higher than that in the general population. As DPP4Is are common diabetes treatments, we must be aware of the risk of BP.

We will continue to monitor the medical literature for further developments concerning Tradjenta (linagliptin) drug-induced bullous pemphigoid (BP) as a potential side effect of this popular diabetes drug.  We will also watch to see whether there is any increased risks of bullous pemphigoid associated with Glyxambi (empagliflozin and linagliptin) or Jentadueto (linagliptin and metformin hydrochloride).

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